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Clean Needle Technique Manual Best Practices for Acupuncture Needle Safety and Related Procedures 7th Edition Published by the Council of Colleges of Acupuncture and Oriental Medicine©2015 CCAOMCleanNeedle TechniqueManual th 7 Edition BestPracticesforAcupunctureNeedleSafetyandRelatedProcedures SeventhEdition Revised January 2016 CouncilofCollegesofAcupunctureandOrientalMedicine www.ccaom.org ©2015bytheCouncilofCollegesofAcupunctureandOrientalMedicine.Reviewedand updatedJanuary11,2016. Allrightsreserved,includingtherighttoreproducethisworkinanyformwhatsoever,without permissioninwritingfromthepublisher,exceptforbriefpassagesinconnectionwithareview. PrintedintheUnitedStatesofAmerica ISBN978-0-9963651-0-9 Editor:JenniferBrett,N.D.,L.Ac. CoverDesign:RobertaMcGrew CoverPhotos:Leaf©123RF.com,NanetteGrebe©123RF.com TheCleanNeedleTechnique(CNT)Manualisintendedforuseprimarilybystate-licensed acupuncturistsandstudentsenrolledinaformalcourseofinstructionataschoolapprovedby theAccreditationCommissionforAcupunctureandOrientalMedicine.Asastatementofbest practicesconcerningacupunctureneedlingandrelatedtechniques,themanualmayalsobe beneficiallyusedbystate-licensedhealthcareprofessionalsinotherdisciplineswhohave acupunctureandrelatedmodalitieswithintheirlawfulscopeofpracticeandbyacupuncturists outsidetheUnitedStateswhoareappropriatelyauthorizedtopracticeacupuncturewithin theirrespectivenationaljurisdictions.Themanualisnotintendedforusebypersonswithout formaltrainingandregulatoryauthorizationtopracticeacupuncture.Themanualfocuseson safetyandisnotaguidetoappropriatetreatmentforparticularhealthconditions.Whilethe manualisintendedtoreflectbestpracticesasofthedateofpublication,opinionsastobest practicesmaydifferandchangeovertime.Ongoingstudyanddebateconcerningbestpractices withintheacademicandpractitionercommunitiesisencouraged.TheCouncilassumesno liabilityforanyinjurythatmayoccurasaresultofapractitioner'suseof,orrelianceupon,any safetyprotocolcontainedinthismanual. TableofContents Preface..............................................................................................................................................xiv Acknowledgements...........................................................................................................................xvi Introduction......................................................................................................................................xvii References.........................................................................................................................................xix PartI:AOMClinicalProcedures,Safety,AdverseEvents(AEs)andRecommendationstoReduceAEs..1 References...........................................................................................................................................2 1.Acupuncture........................................................................................................................................3 Safety/AdverseEvents–AReviewoftheLiterature...........................................................................3 PreventingAcupunctureNeedlingAdverseEvents.............................................................................4 BruisingandBleeding......................................................................................................................4 SafetyGuidelinestoPreventBruising,Bleeding,andVascularInjury..........................................5 NeedleSitePain/Sensation..............................................................................................................5 SafetyGuidelinestoPreventNeedleSitePain.............................................................................6 Fainting............................................................................................................................................7 SafetyGuidelinestoPreventFainting..........................................................................................7 StuckNeedle....................................................................................................................................7 SafetyGuidelinestoAvoidand/orRespondtoStuckNeedle.......................................................8 FailuretoRemoveNeedles..............................................................................................................8 SafetyGuidelinesforNeedleRemoval.........................................................................................9 AggravationofSymptoms................................................................................................................9 SafetyGuidelinesforAggravationofSymptoms........................................................................10 PreventingRarebutSeriousAdverseEvents(SAEs)AssociatedwithAcupunctureNeedling...........10 Pneumothorax...............................................................................................................................10 SafetyGuidelinestoAvoidPneumothorax.................................................................................12 InjurytoOtherOrgans...................................................................................................................13 CentralNervousSystemInjury......................................................................................................15 SafetyGuidelinestoAvoidOrganandCentralNervousSystemInjury......................................15 TraumaticTissueInjury..................................................................................................................15 PeripheralNerves......................................................................................................................15 i BloodVessels.............................................................................................................................16 SafetyGuidelinestoAvoidTraumaticTissueInjury...................................................................16 Infections.......................................................................................................................................16 SafetyGuidelinestoPreventInfection.......................................................................................17 BrokenNeedle...............................................................................................................................18 SafetyGuidelinestoPreventBrokenNeedles............................................................................19 References.........................................................................................................................................19 2.Moxibustion.......................................................................................................................................24 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................24 PreventingMoxibustionAdverseEvents...........................................................................................25 Burns..............................................................................................................................................25 SafetyGuidelinestoPreventMoxaBurns..................................................................................26 SecondaryInfectionfromMoxaBurns..........................................................................................26 SafetyGuidelinestoPreventSecondaryInfectionfromMoxaBurns.........................................27 NauseaorOtherAdverseReactionstoMoxaSmoke....................................................................27 SafetyGuidelinestoPreventAdverseReactionstoMoxaSmoke..............................................27 OtherHeatTherapies.....................................................................................................................27 SafetyGuidelinesforHeatTherapiesOtherthanMoxa............................................................28 References.........................................................................................................................................29 3.Cupping..............................................................................................................................................31 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................31 FireCupping...................................................................................................................................31 SuctionCupping.............................................................................................................................32 WetCupping..................................................................................................................................32 OtherCuppingProcedures.............................................................................................................32 CuppingAdverseEvents....................................................................................................................32 SkinReactions................................................................................................................................32 Cardiovascular................................................................................................................................33 Infections.......................................................................................................................................34 PreventingCuppingAdverseEvents..................................................................................................35 Burns..............................................................................................................................................35 SafetyGuidelinestoAvoidFireCuppingBurns..........................................................................35 ii Infections.......................................................................................................................................35 SafetyGuidelinestoPreventCupping-RelatedInfections..........................................................36 StandardsforReuseofCuppingDevices.......................................................................................36 CleaningandDisinfectingCups......................................................................................................37 SafetyGuidelinesforCupDisinfection.......................................................................................38 ExtensiveBruising&OtherSkinLesions........................................................................................39 SafetyGuidelinesforPreventingCuppingSkinLesions..............................................................39 UnintendedDeepPenetrationoftheNeedle................................................................................39 SafetyGuidelinesforNeedleCupping........................................................................................40 SafetyGuidelinestoPreventCuppingAdverseEvents...............................................................40 References.........................................................................................................................................40 4.Electroacupuncture(EA)....................................................................................................................43 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................43 ExcessiveCurrent...........................................................................................................................44 AnatomicalConsiderations............................................................................................................44 PreventingEAAdverseEvents...........................................................................................................45 SafetyGuidelinesforPreventingEAAdverseEvents..................................................................45 InjuriesDuetoMuscleContraction...............................................................................................45 SafetyGuidelinesforPreventingExcessiveMuscleContractionDuringEA...............................45 ElectricalInjury..............................................................................................................................46 SafetyGuidelinesforPreventingElectricalInjuryDuringEA......................................................46 InterferencewithaCardiacPacemaker.........................................................................................46 SafetyGuidelinesforPreventingInterferencewithaCardiacPacemakerDuringEA................46 References.........................................................................................................................................46 5.TherapeuticBloodWithdrawal..........................................................................................................48 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................48 PreventingAcupunctureBleedingTherapyAdverseEffects..............................................................49 SafetyGuidelinesforAcupunctureBleedingTherapy................................................................50 References.........................................................................................................................................50 6.GuaSha..............................................................................................................................................52 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................52 PreventingGuaShaAdverseEvents..................................................................................................53 iii SafetyGuidelinesforGuaSha....................................................................................................53 DisinfectionofGuaShaDevices.....................................................................................................54 SafetyGuidelinesforDisinfectionofGuaShaTools...................................................................55 References.........................................................................................................................................55 7.PlumBlossomNeedling.....................................................................................................................57 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................57 PreventingPlumBlossomNeedlingAdverseEvents.........................................................................57 SafetyGuidelinesforPlumBlossom(SevenStar)Therapy.........................................................57 References.........................................................................................................................................58 8.PressTacksandIntradermalNeedles................................................................................................59 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................59 AuricularTherapy/PressTacks.......................................................................................................59 IntradermalNeedling.....................................................................................................................59 SafetyGuidelinesfortheUseofPressTacksorIntradermalNeedling......................................60 References.........................................................................................................................................61 9.EarSeeds............................................................................................................................................63 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................63 PreventingEarSeedAdverseEvents.................................................................................................63 SafetyGuidelinesfortheUseofEarSeeds.................................................................................63 References.........................................................................................................................................63 10.TuiNa...............................................................................................................................................64 Safety/AdverseEvents–AReviewoftheLiterature.........................................................................64 PreventingTuiNaAdverseEvents.....................................................................................................65 SafetyGuidelinesforTuiNa.......................................................................................................65 References.........................................................................................................................................65 11.OtherAcupuncture-RelatedTools...................................................................................................67 Manaka/JapaneseAcupunctureTools...............................................................................................67 AReviewoftheLiterature.............................................................................................................67 PreventingAdverseEvents............................................................................................................67 ShonishinPediatricJapaneseAcupunctureTools..............................................................................67 AReviewoftheLiterature.............................................................................................................67 PreventingCommonAdverseEvents.............................................................................................67 iv PartII:BestPracticesforAcupuncture-CNT......................................................................................68 1.CNTProtocol......................................................................................................................................68 HandSanitation.................................................................................................................................69 SafetyGuidelinesforHandSanitation...........................................................................................69 PreparingandMaintainingaCleanField...........................................................................................70 SafetyGuidelinesforPreparingandMaintainingaCleanField.....................................................70 SkinPreparation.................................................................................................................................71 AlcoholSwabMethod....................................................................................................................72 SafetyGuidelinesforSkinPreparation...........................................................................................73 IsolationofUsedSharps....................................................................................................................73 StandardPrecautions.........................................................................................................................74 BasicStepsoftheCleanNeedleTechniqueforAcupuncture............................................................74 2.CNTBasicPrinciples...........................................................................................................................76 SettingUptheCleanField..................................................................................................................77 InspectingNeedlePackagingPriortoUse.........................................................................................78 SkinPreparation.................................................................................................................................78 PalpatingthePoint............................................................................................................................78 InsertingNeedletoCorrectDepth.....................................................................................................79 NeedleRemoval.................................................................................................................................80 DealingwithBloodtoBloodContact.................................................................................................80 ManagingUsedNeedles................................................................................................................80 CountingNeedles...........................................................................................................................81 3.CNTinanOfficeSetting.....................................................................................................................82 TreatmentProtocolinanOfficeSetting............................................................................................82 4.CNTforHouseCalls/TravelSetting....................................................................................................84 TravelKit/TravelKitCarrier...............................................................................................................84 CleanItems....................................................................................................................................84 Non-CleanItems............................................................................................................................85 TravelKitItemsNotinBags...........................................................................................................85 HandCleanser................................................................................................................................86 TravelSharpsContainer.................................................................................................................86 PreparingtheKit................................................................................................................................86 v TreatmentProtocolinaTravelSetting..............................................................................................86 5.CNTinaCommunityAcupunctureClinicorNADASetting................................................................89 TreatmentProtocolinaCommunityClinicorNADASetting.............................................................89 6.CNTinaPublicHealthSetting............................................................................................................91 Handwashing.....................................................................................................................................91 AcupunctureEquipment....................................................................................................................92 PositioningthePatient.......................................................................................................................92 RemovingNeedles.............................................................................................................................92 PotentialComplications.....................................................................................................................93 7.ToyohariAcupuncture.......................................................................................................................94 ModificationstoStandardCleanNeedleTechniqueforContactNeedling.......................................94 8.SummaryofSafetyRecommendationsforCleanNeedleTechnique................................................95 References.........................................................................................................................................98 PartIII:BestPracticesforRelatedAOMOfficeProcedures...............................................................101 1.Moxibustion.....................................................................................................................................102 MoxibustionOverview.....................................................................................................................102 GeneralMoxibustionPrecautions...................................................................................................103 MoxaBestPracticeGuidelines.........................................................................................................104 DirectMoxibustion-TechniqueforNon-ScarringMoxibustionwithMoxaCones.....................104 Method....................................................................................................................................104 SafetyConsiderations..............................................................................................................105 DirectMoxibustion-TechniqueforScarringMoxibustionwithMoxaCones.............................105 Method....................................................................................................................................105 SafetyConsiderations..............................................................................................................106 IndirectMoxibustion–TechniquewithInterposedMoxibustion................................................107 Method....................................................................................................................................107 SafetyConsiderations..............................................................................................................108 IndirectMoxibustion-WarmingNeedleMoxibustion................................................................108 Method....................................................................................................................................108 SafetyConsiderations..............................................................................................................109 IndirectMoxa–TechniquewithMoxaStick................................................................................110 Method....................................................................................................................................110 vi SafetyConsiderations..............................................................................................................110 MoxaDisposal..............................................................................................................................111 2.HeatLamps......................................................................................................................................112 BestPracticeProtocolsforHeatLamps...........................................................................................112 Method........................................................................................................................................112 SafetyConsiderations..................................................................................................................112 3.Cupping............................................................................................................................................114 CuppingOverview............................................................................................................................114 GeneralRecommendationsforCupping..........................................................................................114 SampleBestPracticeProtocolsforCupping....................................................................................115 FireCuppingMethod...................................................................................................................116 SafetyConsiderations..................................................................................................................116 SuctionCupping...............................................................................................................................117 Method........................................................................................................................................117 WetCupping....................................................................................................................................117 Method........................................................................................................................................118 4.TherapeuticBloodWithdrawal........................................................................................................119 BleedingOverview...........................................................................................................................119 GeneralRecommendationsforBleedingTechniques......................................................................119 SampleBestPracticeProtocolforBleedingAcupuncturePoints....................................................119 Method........................................................................................................................................120 5.PlumBlossom/SevenStarNeedle....................................................................................................122 PlumBlossomOverview..................................................................................................................122 GeneralRecommendationsforPlumBlossom................................................................................122 BestPracticeProtocolsforPlumBlossom.......................................................................................122 Method........................................................................................................................................123 6.GuaSha............................................................................................................................................124 GuaShaOverview............................................................................................................................124 SummaryofGuaShaRecommendations........................................................................................124 GuaShaBestPracticeProtocols......................................................................................................125 Method........................................................................................................................................125 7.AcupointInjectionTherapies...........................................................................................................126 vii AcupointInjectionTherapyBestPracticeProtocols........................................................................127 SafetyConsiderations..................................................................................................................128 SummaryofSafetyRecommendationsforCleanInjectionTechnique............................................129 References.......................................................................................................................................129 PartIV–InfectionsAssociatedwithAcupunctureandRelatedHealthcarePractices........................131 1.Pathogens........................................................................................................................................131 2.MechanismsofDiseaseTransmission..............................................................................................131 AutogenousInfections.....................................................................................................................132 Cross-Infections...............................................................................................................................132 3.BloodbornePathogens....................................................................................................................133 Hepatitis...........................................................................................................................................133 HepatitisA(HAV).............................................................................................................................134 HepatitisASurvivalintheEnvironment......................................................................................134 HepatitisB(HBV).............................................................................................................................135 TransmissionofHBV....................................................................................................................135 HBVSurvivalintheEnvironment.................................................................................................136 IndividualsatRiskofHBVInfection.............................................................................................136 ExposuretoHBV..........................................................................................................................137 HBVVaccination...........................................................................................................................137 TheHBVInfectionProcess...........................................................................................................138 TreatmentofHBV........................................................................................................................139 HepatitisC(HCV)..............................................................................................................................139 AcuteSymptomsofHepatitisC...................................................................................................140 RiskFactorsforHCVInfection......................................................................................................140 HCVSurvivalintheEnvironment.................................................................................................141 ConsequencesofHCVInfection...................................................................................................141 HepatitisD(HDV).............................................................................................................................141 HDVSurvivalintheEnvironment.................................................................................................142 HepatitisE(HEV)..............................................................................................................................142 ChronicCarriersofHepatitis............................................................................................................142 PreventionofHepatitis....................................................................................................................143 Table1:SummaryofHepatitisCharacteristics............................................................................143 viii HumanImmunodeficiencyDisease(HIV)........................................................................................143 HIVTransmission.........................................................................................................................144 HIVSurvivalintheEnvironment..................................................................................................145 RiskofTransmissionthroughInvasiveProcedures......................................................................145 IndividualsatRiskofHIVInfection..............................................................................................145 Testing..........................................................................................................................................146 Reporting.....................................................................................................................................147 TheHIVInfectionProcess............................................................................................................147 TreatmentofHIV.........................................................................................................................148 AdditionalRiskstoHealthcareWorkers(HCWs).........................................................................148 4.OtherHealthcareAssociatedInfections..........................................................................................149 Tuberculosis.....................................................................................................................................149 TBSurvivalOutsideHost..............................................................................................................151 AcupunctureTBSafety.................................................................................................................151 SkinInfections..................................................................................................................................151 Staphylococcus............................................................................................................................151 Methicillin-ResistantStaphylococcusAureus(MRSA).................................................................152 Prevention................................................................................................................................152 MRSASurvivalintheEnvironment..........................................................................................153 Streptococcus..............................................................................................................................153 MycobacteriaOtherthanTuberculosis(MOT)............................................................................153 HerpesSimplex............................................................................................................................154 Influenza..........................................................................................................................................155 InfluenzaSurvivalintheEnvironment.........................................................................................155 CDCFundamentalElementstoPreventInfluenzaTransmission.................................................156 Norovirus.........................................................................................................................................156 PreventionofNorovirus...............................................................................................................156 Clostridiumdifficile..........................................................................................................................157 PreventionofSpreadofClostridiumdifficile...............................................................................158 5.SummaryofPreventionofDiseaseTransmissioninAcupuncturePractice.....................................159 BasicCriticalPrinciples.....................................................................................................................159 PreventingPatienttoPatientCrossInfections–CriticalRecommendations..................................159 ix PreventingPatienttoPractitionerCrossInfections.........................................................................159 PreventingPractitionertoPatientCrossInfections.........................................................................159 Review..............................................................................................................................................160 References.......................................................................................................................................160 PartV:PersonnelHealth,CleanlinessandSafetyPractices...............................................................168 1.Handwashing...................................................................................................................................168 EffectiveHandwashingTechnique...................................................................................................169 HandHygieneTechnique:SoapandWater.....................................................................................169 HandDrying.....................................................................................................................................170 HandHygieneTechnique-Alcohol-BasedSanitizers.......................................................................170 Handwashing-AntisepticTowelettes.............................................................................................170 HandFlora........................................................................................................................................171 Rings/Jewelry...................................................................................................................................171 HealthcareworkersandActualHandwashingPractices..................................................................171 NecessityofHandwashing...............................................................................................................171 Whatistherightwaytowashyourhands?.....................................................................................172 Recommendations...........................................................................................................................173 2.PatientSkinPreparation..................................................................................................................173 AlcoholSwabMethod......................................................................................................................175 OptionsforSkinPreparation...........................................................................................................175 Recommendations...........................................................................................................................176 3.RecommendationsforPractitionerHealthandHygiene.................................................................176 YearlyPhysical.................................................................................................................................177 Clothing............................................................................................................................................177 HandCare........................................................................................................................................177 PersonalHealth................................................................................................................................177 TestingforTB,HBV,HCVandHIV....................................................................................................178 TBtesting.....................................................................................................................................178 HBVtesting..................................................................................................................................178 HCVtesting..................................................................................................................................178 HIVtesting....................................................................................................................................179 4.PersonalProtectiveEquipment(PPE)..............................................................................................179 x Areglovesneededforacupunctureneedleinsertion?....................................................................181 Areglovesneededforacupunctureneedleremoval?.....................................................................182 5.NeedlestickInformation..................................................................................................................183 References.......................................................................................................................................183 PartVI:CleaningandPathogenReductionTechniquesinHealthcareandAOMPracticeLocations...189 1.Disinfectants....................................................................................................................................189 ClassificationsofDisinfectants.........................................................................................................190 TypesofDisinfectants......................................................................................................................190 ChlorineandChlorineCompounds..............................................................................................190 MicrobiocidalActivity..............................................................................................................191 Glutaraldehyde............................................................................................................................191 Hydrogenperoxide......................................................................................................................192 Iodophors.....................................................................................................................................192 Phenol..........................................................................................................................................192 EPAandFDAApprovalofDisinfectants...........................................................................................192 MonitoringandLabelingofDisinfectants........................................................................................192 2.IndicationsforSterilization,High-LevelDisinfection,andLow-LevelDisinfection..........................193 3.CleaningEquipment.........................................................................................................................193 ReuseofSingle-UseMedicalDevices...............................................................................................193 Pre-cleaningofReusableMedicalEquipment.................................................................................193 InstrumentCleaning........................................................................................................................194 SafetyGuidelinesforDisinfectingReusableMedicalEquipment................................................194 4.CleanUseofLubricants....................................................................................................................196 5.CleaningandDisinfectingEnvironmentalSurfacesinHealthcareFacilities....................................196 UseofDisinfectantsforSurfaceCleaning........................................................................................197 6.BloodorBodyFluidSpills.................................................................................................................197 7.LaunderingSheets,TowelsorOtherLinens.....................................................................................198 8.SharpsandNon-SharpsBiohazardEquipmentandDisposal...........................................................198 9.RegulatedWaste..............................................................................................................................199 Disposal............................................................................................................................................200 ContaminatedLaundry....................................................................................................................200 SummaryofRecommendations–PartVI............................................................................................201 xi References.......................................................................................................................................202 PartVII:OfficeProceduresforRiskReduction..................................................................................204 1.FederalStandardsandGuidelines...................................................................................................205 OSHA:BloodbornePathogensStandard..........................................................................................205 StandardPrecautions.......................................................................................................................206 NSPA................................................................................................................................................206 OSHA:ExposureControlPlan..........................................................................................................207 OSHA:HazardousCommunication..................................................................................................210 OSHA:OtherHazards.......................................................................................................................211 OSHA:DisposingofBiohazardousWaste........................................................................................211 Discardinggloves,cottonballsandothermaterialcontaminatedwithblood............................213 Whatshouldpatientsdowithpresstacksorotherimbeddeddevicesthattheyneedtoremove athome?......................................................................................................................................213 2.SafetyConsiderationsRegardingthePracticeEnvironment...........................................................214 3.Recordkeeping.................................................................................................................................215 Charting...........................................................................................................................................215 GeneralChartingConsiderations.................................................................................................215 StandardRequirementsforAOMcharting..................................................................................217 DailyAppointmentSchedules..........................................................................................................219 4.PatientConfidentiality.....................................................................................................................219 HIPAAHealthInformation...............................................................................................................219 ReportingofCommunicableDiseaseandAbuse.............................................................................221 5.InformedConsent............................................................................................................................221 6.High-RiskPatients............................................................................................................................222 7.OtherImportantSafetyPractices....................................................................................................222 PreventingTripsandFalls................................................................................................................222 HowtoPreventFallsDuetoSlipsandTrips................................................................................223 ResponsetoaBodilyFluidSpill........................................................................................................223 FirstAid............................................................................................................................................223 MentalHealthIssues/Suicide..........................................................................................................224 8.SummaryofRecommendations–PartVII.......................................................................................224 References.......................................................................................................................................225 xii PartVIII–Appendices......................................................................................................................227 AppendixA:Glossary/Abbreviations...................................................................................................227 AppendixB:WheretoFindMoreInformation....................................................................................233 HealthcareAssociatedInfections.....................................................................................................233 CDC/SpecificPathogens...................................................................................................................233 Hepatitis.......................................................................................................................................233 HIV...............................................................................................................................................234 TB.................................................................................................................................................234 OtherDiseases.............................................................................................................................234 Handwashinginformationanddetails.........................................................................................235 StandardPrecautions...................................................................................................................235 OSHADocumentsandTrainingRequirements................................................................................235 OSHABloodbornePathogenStandards.......................................................................................235 ExposureControlPlan(ECP)Samples..........................................................................................235 OSHADocumentsRelatingtoECPs..............................................................................................235 HazardousCommunication..........................................................................................................235 HIPAA...............................................................................................................................................236 AppendixC:AcupuncturePointsthatRequireSpecialSkill.................................................................237 References.......................................................................................................................................239 CleanNeedleTechnique7thEditionFAQ.........................................................................................240 Index...............................................................................................................................................246 xiii Preface TheprofessionofacupunctureandOrientalmedicine(AOM)intheUnitedStatescontinuesto growandevolve.Aspartofthisevolution,practitionersareprovidingacupunctureservicesin hospitals,integratedmedicalcenters,andteachingclinics.Asmoreacupuncturistsprovidecare inthiscomplexarrayofintegratedsettings,theneedforevidenced-basedbestpracticesin safetyisessential.AcupunctureeducationintheU.S.hasevolvedtomeetthischallenge. Accordingly,AOMinstitutionsthathaveachievedaccreditationoraccreditationcandidacy statuswiththeAccreditationCommissionforAcupunctureandOrientalMedicine(ACAOM) continuetoexpandtheircurriculumtomeetthechangingneedsoftheprofession,including courseworkinbioscience,evidence-basedpractice,riskmanagement,andsafeclinical practices. TheinformationavailablefromtheCentersforDiseaseControlandPrevention(CDC),the OccupationalSafetyandHealthAdministration(OSHA),aswellasstateandlocalhealth departments,hasalsoevolvedsincethereleaseofpreviouseditionsoftheCleanNeedle TechniqueManual.Changingepidemiologicalpatterns,changesinwhatisconsideredbest practicesincleanandaseptictechnique,andchangesintechnologyhaveallcontributedto improvingclinicalsafety.WhathasnotchangedistheneedforacupuncturiststoapplyClean NeedleTechniquescrupulouslyassafetyremainsacriticalaspectofclinicalpractice. ThepurposeoftheCleanNeedleTechniqueManualhasalsoevolved.Thefirsteditionofthe manualwasoneofthefewEnglishlanguagesourcescoveringsafepracticestandardsfor acupuncturists.AOMeducationalinstitutionsnowhavearangeofresourcesandan accreditationmandatetocoverbloodbornepathogens,safepractice,emergencyprocedures, riskmanagement,andsafetyprotocolsintheircurricula.InformationprovidedintheClean NeedleTechniqueManualhasalsospreadglobally,promotingbettersafetystandards worldwide. Needlingandotherrelatedacupunctureproceduresarecarriedoutinauniquemannerwhere needlesmaybeplacedintotissueandremoved,ormaybeplacedintotissueandresidefora periodoftimebeforetheirremoval.Othermodalitiesmayalsobeappliedontothesurfaceof theskinandlikewisebeimmediatelyremovedorretainedforaperiodoftime.Assuch,the applicationofevidenced-basedbestsafetypracticestakesintoaccountthemannerandtiming oftreatment.IndevelopingtheCleanNeedleTechniqueManual,expertsfromOSHAandthe CDCwereconsultedtoensurethattherecommendationsinthemanualmeetcurrentOSHA andCDCstandards. TheCleanNeedleTechniqueManualplaysanimportantroleinpreparingacupuncturestudents forsafepracticeandprovidingbasicinformationrequiredfornationalcertificationin xiv acupuncturebytheNationalCertificationCommissionforAcupunctureandOrientalMedicine (NCCAOM)andforstatelicensure.Thismanualsummarizesimportantprinciplesthatgovern safepracticesuitedtosupporttheworkdoneinintroductoryacupuncturetechniquecoursesin acupuncturecollegesandtheCleanNeedleTechniquecourseofferedbytheCouncilofColleges ofAcupunctureandOrientalMedicine(CCAOM).Theinformationinthismanualsupportsand contributestotheeducationalcurriculaintheareasofAOMofficeproceduresafety, bloodbornepathogens,andriskreductionconcerningacupunctureandotheradjunctive therapiesaspracticedinprivatepractice,conventionalandCAMintegratedclinicalsettings, andintheteachingclinicsinaccreditedAOMprograms. ThislatesteditionoftheCleanNeedleTechniqueManualhasbeenexpanded,updated,and exhaustivelyreviewed.Whileeveryefforthasbeenmadetoensurethatup-to-datestatistics wereincludedwithrespecttoadverseeventsarisinginAOMofficepractices,includingthe smallriskofspreadinginfectiousdiseases,itisimportanttorememberthatthesestatisticsare constantlychanging.Acupuncturepractitionerscanfindupdatedinformationregarding healthcareassociatedillnessesonU.S.governmentwebsites,anumberofwhicharelistedin AppendixB. xv Acknowledgements TheseveneditionsoftheCleanNeedleTechnique(CNT)Manualrepresentthecollectivethinking andenergyofNationalAcupunctureFoundationBoardMembers,NCCAOMCommissioners,Council ofCollegesofAcupunctureandOrientalMedicineCleanNeedleTechniqueCommitteeMembers, andCNTInstructorsandcolleaguesacrosstheUnitedStates. TheNationalAcupunctureFoundationBoardMembersinvolvedincludeMalvinFinkelstein,L.Ac.; BarbaraMitchell,J.D.,L.Ac.,(Editor,fourthandfifthedition);WilliamSkelton,L.Ac.;andJames Turner,J.D. TherollcalloftheCommissionersoftheNationalCertificationCommissionforAcupunctureand OrientalMedicine(NCCAOM)involvedintheprocessincludesJuneBrazil,L.Ac.;EdithDavis(Editor); GlennEarl,L.Ac.;StevenFinando,Ph.D.,L.Ac.;AlanFrancis;DanielJiao,L.Ac.;StuartKutchins,L.Ac.; JimMcCormick,L.Ac.(Editor);MarkSeem,Ph.D.,L.Ac.;AngelaTu,L.Ac.;andGraceWong,L.Ac. OtherprofessionalswhomadevaluablecontributionsincludeRezanAkpinar,D.D.S.(Europe),M.S., L.Ac.,L.M.T.;AnnBailey,L.Ac.;MatthewBauer,L.Ac.;JennyBelluomini,N.D.;MaryC.Bolster,M.S., R.N.;EdnaM.Brandt,M.Ac.,L.Ac.,Dipl.Ac.;RalphCoan,M.D.;GaryDolowitz,M.D.;RobertDuggan, L.Ac.;KevinErgil,L.Ac.;SteveGiven,D.A.O.M.,L.Ac.;MarthaHoward,M.D.(Editor);HaigIgnatius, M.D.;JosephKay,L.Ac.;DekeKendall,L.Ac.;PatriciaKlucas,R.N.;SuLiangKu,C.A.;ShenPingLiang, L.Ac.;WilliamMueller,L.Ac.;TomRiihimaki;FlorencePatriciaRoth,M.S.,L.Ac.;RonSokolsky, M.S.O.M.,L.Ac.,Dipl.Ac./C.H.;TierneyTully,M.S.O.M.,L.Ac.;BrookeWinter,L.Ac.;JulieZinkus, L.Ac.;andWalterBondoftheCentersforDiseaseControlandPrevention. JenniferBrett,N.D.,L.Ac.istheprincipaleditorforthepresent7theditionofthemanual. SubstantivecommentsconcerningthemanualwerereceivedbyMichaelJabbour,C.S.P.,M.S.,L.Ac.; LixingLao,Ph.D.,C.M.D.(China),L.Ac.;ZoeBrenner,L.Ac;andtheCouncil’sCNTinstructorsDarlene Easton,M.S.,Dipl.OM,L.Ac.;DanielJiao,D.A.O.M,L.Ac.;XiaotianShen,L.Ac.,M.P.H.;andJamie (Qianzhi)Wu,L.Ac.,M.S.,M.D.(China).CCAOMCNTCo-chairsValerieHobbs,Dipl.OM,L.Ac.; BarbaraEllrich,M.A.;CNTProgramManagerPaulaDiamond,B.A.;CCAOMExecutiveDirectorDavid Sale,J.D.,LL.M.,andCCAOMAdminstrativeAssistantMaryValle,B.A.,alsomadesignificant editorialcontributionstothemanual.AppreciationisexpressedtoJeffreyHageman,M.H.S.,Deputy Chief,PreventionandResponseBranch,DivisionofHealthcareQualityPromotion,Centersfor DiseaseControlandPrevention;andhiscolleaguesattheCDCfortheircommentsconcerning severalaspectsofCNTprotocolthatareaddressedinthismanual.Additionalappreciationis expressedtoDouglasJ.Kalinowski,Director,DirectorateofCooperativeandStatePrograms,federal OccupationalSafetyandHealthAdministration,forOSHA’scommentsconcerningaCNTprotocol issue. xvi Introduction In1984,attherequestoftheacupunctureprofession,theNationalCertificationCommission forAcupunctureandOrientalMedicine(NCCAOM)developedguidelinesandrecommendations forthesafeandcleanpracticeofacupuncture.Theguidelineswerebasedonthetheoryand practiceofsafetycommonlyusedinhealthcare.Conscientioususeoftheprocedures recommendedanddescribedinthismanualwillreducetheriskofspreadinginfectionand accidentsinthepracticeofacupuncture. Increasingknowledge,alongwiththeapplicationofStandardPrecautions,safeclinical practices,andriskmanagementtechniques,reducestheriskofanumberofpotentialadverse eventsrelatedtoacupuncturepractice,reducesthespreadofinfection,andhelpensurepublic safety.Furthermore,fromthemedical,legal,andethicalperspectives,itisthepractitioner’s responsibilitytoensurethatCleanNeedleTechniquehasbeenfollowedcorrectly. Inadditiontogeneralpublichealthsources,suchastheCDC,OSHA’sBloodbornePathogens Standards,andtheU.S.PublicHealthService,theinformationinthismanualhasbeendrawn fromacupunctureresearchthroughouttheworldandadaptedtotheuniquerequirementsand thepracticeofacupuncture.Thus,manyoftherecommendationsinthismanualare modificationsoftechniquescurrentlyinusethroughouttheUnitedStatesinmanyhealthcare professions.Theguidelinesandstandardsthathavebeendevelopedaretheresultofthe synthesisofEastAsianandWesternresourcesfromacademic,research,andclinicalarenas. Thismanualreflectsthecurrentunderstandingofbestpracticesinthefieldofacupuncture clinicaltechniques.Bestpracticesaredefinedas“activities,disciplinesandmethodsthatare availabletoidentify,implementandmonitortheavailableevidenceinhealthcare…These activitiesgaininputmainlythroughfourdisciplines:clinicalresearch,clinicalepidemiology, healtheconomicsandhealthservicesresearch.”(1)Inthisapplication,bestpracticeprinciples arebeingusedtolimitrisksassociatedwithacupunctureclinicalpractices. Thesepracticesarethebasisofboththewrittenandpracticaltrainingandexamportionsofthe CNTcourseandexamofferedbytheCouncilofCollegesofAcupunctureandOrientalMedicine. Acupunctureschoolsandpractitionersneedtomaintainanawarenessofinformationalupdates concerningsafetyinmanyareasofpractice(includinghealthcareassociatedinfectionsand OSHAbloodbornepathogensstandards),andcontinuallyupdatetheirunderstandingofthe bestclinicalpracticesinthefield. Thismanualisnotmeanttodefinestandardpracticesorstandardofcareinacupuncture techniques.Thetermstandardofcareisoftenusedsynonymouslywithcustomarypractice.Itis xvii alegaltermthatiscommonlydefinedas“whataminimallycompetentphysicianinthesame fieldwoulddointhesamesituation,withthesameresources.”(2) Standardsofcareinmedicinemayalsobedefinedasthecustomarypracticeofaparticular areaorlocality.Acupunctureclinicalpracticesvarybyschool,region,andtraining.Giventhe historicallywidevarietyofvalid,documentedacupunctureclinicalpractices,thismanualcannot beutilizedtodefineacupuncturestandardpractices. Forthepurposesofthismanual,thefollowingtermswillbeutilizedtohelpacupuncture practitionersapplybestpracticestotheirpersonalpractices: Critical:Thisaddressestheareaofhighestclinicalrisk.Theprotocolisconsideredessentialfor thesafetyofthepatientandpractitioner,andscientificdatademonstratesthatomissioncould constituteaseriouspublichealthrisk. StronglyRecommended:Thesemeasuresarestronglysupportedbyclinicalstudiesthatshow effectivenessofthemeasuresinreducingriskorareviewedasimportantbyhealthcare practitioners.Theyareconsideredessentialmeasuresandfrequentlyaddressareasofhigh clinicalrisk. Recommended:Thesemeasuresincludetwotypesofrecommendations:(1)thosethatare supportedbyhighlysuggestive,butperhapslesseasilygeneralized,clinicalstudiesinarelated field,and(2)thosethathavenotbeenadequatelyresearched,buthaveastrongtheoretical rationaleindicatingthattheyareeffectiveforcleanandsafepractice.Bothtypesof recommendationsarejudgedtobepracticaltoimplement,butarenotconsideredessential practiceforeverypractitionerineverysituation.Practitionersshould,however,considerthese recommendationsforimplementationintotheirpractices. Acupunctureproceduresareperformedaspartoftheauthorizedscopeofpracticeofsome otherhealthcareprofessions.Moreover,somehealthcarepractitionersuseterminologyfrom theirownprofessionfortherapeuticneedlingtechniquesthatisindistinguishablefrom therapeuticneedlingtechniqueinthepracticeofacupuncture.Triggerpointdryneedling,dry needling,functionaldryneedling,andintramuscularmanualtherapyfallintothiscategory. Otherhealthcareproviderswhomayuseneedlingtechniquesintheirpractice,whetherornot theprovidersdescribethesetechniquesasacupuncture,aresubjecttothesamesafety guidelinessincethesafetyguidelinesapplyaccordingtowhattoolthepractitionerisusingand howthattoolisappliedinthecourseoftreatment.Accordingly,throughoutthismanualthe generalterm“practitioner”isusedinasmuchasthesafetystandardscontainedinthemanual representbestpracticesapplicabletoanyhealthcarepractitionerwhousesafiliformneedleor relatedtechniquesasdescribedherein. xviii Practitioners,instructors,patients,andothersoftencontacttheCCAOMnationalofficefor clarificationconcerningthebestsafetytechniquesforacupunctureprocedures. OverviewoftheSections: • InPartIofthemanual,theliteratureidentifyingthepotentialforinfectionsandother adverseeventsandthereforetheneedforspecifictechniquesandskillsisreviewedasa rationaleforbestpractices. • InPartII,safetyconsiderationsforneedlingaredescribedindetailandtheprecautions fromPartIarerepeated.Therepetitionisintentionalasbothateachingtoolandto reinforcethefactthatbestpractices,includingCleanNeedleTechniquebasics,applyin allsituations. • InPartIII,samplebestpracticesforotherAOMofficeproceduresarediscussedandthe precautionsfromPartIrepeatedspecificallyforthesepractices.Theprocedurestolimit burnsassociatedwithmoxibustionapplyevenwhendifferentformsofmoxaare utilized.Room,tableandpractitionerpreparationarethesamenomatterwhattypesof treatmentsarebeingrendered.Ifusedasateachingtool,thismanualmakessuch repetitionnecessaryandbeneficial. • PartIVdetailsthehealthcareassociatedinfectionsconcerningwhichacupuncture practitionersneedtobeaware,bothbloodborneandcontactassociatedinfections. • PartVdiscussespersonnelsafetypractices. • PartVIdiscussescleaningoftheoffice,equipmentandlaundry. • PartVIIreviewssomeoftheimportantfederalregulationsandnationwidestandardsfor riskreductionthatapplytoacupuncturepractitioners. • PartVIIIcontainsappendicesforpractitionerinformation. References 1.PerlethM.,JakubowskiE.,BusseR.Whatis'bestpractice'inhealthcare?Stateoftheartand perspectivesinimprovingtheeffectivenessandefficiencyoftheEuropeanhealthcare systems.HealthPolicy.2001Jun;56(3):235-50. 2.MoffettP,MooreG.TheStandardofCare:LegalHistoryandDefinitions:theBadandGood News.WestJEmergMed.2011February;12(1):109–112. xix Part I: AOM Clinical Procedures, Safety, Adverse Events (AEs) and Recommendations to Reduce AEs Safetyremainsthemostimportantconsiderationforallclinicians,includingacupuncturists.Any clinicalefficacyispotentiallyendangeredwhenaclinicianisnotcognizantofthepotentialrisks ofaclinicalproceduretothepatient,patient’sfamily,ortheclinicianandclinicalstaff.Thefield ofacupuncturehasflourishedintheUnitedStatesinpartbecauseacupuncturistsareperceived bymembersofthepublic,stateregulators,andotherproviderstobewelltrainedandthe practiceofacupuncturetoberelativelysafe.Inthissection,commonlyusedacupunctureand relatedclinicaltechniqueswillbereviewedfortheirsafetyhistoryalongwithanoverviewof thebestpracticesforlimitingadverseevents(AEs).Detailsofsafetyprotocolsforacupuncture andAOM-associatedclinicalprocedureswillbegiveninPartIIandPartIII. AccordingtotheWorldHealthOrganization(WHO):(1) Incompetenthands,acupunctureisgenerallyasafeprocedurewithfew contraindicationsorcomplications.Itsmostcommonlyusedforminvolvesneedle penetrationoftheskinandmaybecomparedtoasubcutaneousorintramuscular injection.Nevertheless,thereisalwaysapotentialrisk,howeverslight,oftransmitting infectionfromonepatienttoanother(e.g.,HIVorhepatitis)orofintroducing pathogenicorganisms.Safetyinacupuncturethereforerequiresconstantvigilancein maintaininghighstandardsofcleanliness,sterilizationandaseptictechnique. Thereare,inaddition,otherriskswhichmaynotbeforeseenorpreventedbutforwhich theacupuncturistmustbeprepared.Theseinclude:brokenneedles,untoward reactions,painordiscomfort,inadvertentinjurytoimportantorgansand,ofcourse, certainrisksassociatedwiththeotherformsoftherapy classifiedundertheheadingof “acupuncture.”Acupuncturetreatmentisnotlimitedtoneedling,butmayalsoinclude: acupressure,electroacupuncture,laseracupuncture,moxibustion,cupping,scraping andmagnetotherapy. Finally,therearetherisksduetoinadequatetrainingoftheacupuncturist.These includeinappropriateselectionofpatients,errorsoftechnique,andfailuretorecognize contraindicationsandcomplications,ortodealwithemergencieswhentheyarise. [LicensedacupuncturistsintheU.S.arewell-trained.Asnotedintheintroductiontothis manual,thereareanumberofhealthcarepractitioners,however,whoutilizeacupuncturewith minimalandinadequatetraining.—Ed.] 1 Thisfirstpartofthemanualisareviewofthemedicalliteraturedetailingthesafetyofvarious acupunctureandrelatedAOMpracticesalongwiththeuncommonrisksorcomplicationsthat mayarisefromthesepractices.Pleasenotethatthispublicationdoesnotcoverthesafety issuesthatmayarisewhenutilizingmateriamedica,whichisbeyondthescopeofthismanual. Thereareanumberofacupunctureproceduresforwhichthereareveryfewornostudiesof adverseevents(AEs).SomeofthestudiesthatincludeAEsintheirreportingarelimitedintheir application.Usingtheprinciplesofevidence-informedpractices,theinformationpresented hereisthebestinformationavailableatthetimeofpublication.Whilethereareanumberof welldevisedandreportedstudiesoftheminimalAEsassociatedwithacupunctureneedling, better,largerstudiesofAEsassociatedwithmoxibustion,guasha,tuinaandotherprocedures areneeded.Whenthesebecomeavailablerecommendationsforbestpracticesinthese proceduresmaychange. References 1.GuidelinesonBasicTrainingandSafetyinAcupuncture.WorldHealth Organization.http://apps.who.int/medicinedocs/en/d/Jwhozip56e/Published1996. AccessedDecember2012. 2 1. Acupuncture Safety/Adverse Events – A Review of the Literature Acupunctureistheinsertionofneedlesintotheskinwherethetherapeuticeffectisexpected tocomeprimarilyfromtheactofinserting,manipulatingand/orretainingtheneedlesin specificlocations.Whileacupuncturepointsmaybestimulatedbyavarietyofmethodsby acupuncturepractitioners(needling,moxibustion,cupping,manualpressure,electrical stimulation,laserstimulation,magnets,plumblossom,bleeding,andinjectiontherapiesamong others),whentheprimaryeffectisexpectedfromtheactofinsertingtheneedleitself,thisis acupuncture. EarlyreviewsoftheliteratureincludethosebyErnstandWhite,andLaowhoconclude:“The riskofseriouseventsoccurringinassociationwithacupunctureisverylow,belowthatofmany commonmedicaltreatments.”(1)“AcupunctureperformedbytrainedpractitionersusingClean NeedleTechniqueisagenerallysafeprocedure.”(2) Laoetal.reviewedliteraturecoveringtheyears1965-1999.“Overthe35years,202incidents wereidentifiedin98relevantpapersreportedfrom22countries…Typesofcomplications includedinfections(primarilyhepatitisfromafewpractitioners),andorgan,tissue,andnerve injury.Adverseeffectsincludedcutaneousdisorders,hypotension,fainting,andvomiting.There isatrendtowardfewerreportedseriouscomplicationsafter1988.”(2) Itshouldbenotedthatsingle-usedisposablesterileneedleswerebecomingmorefrequentin useinthelatterhalfofthe1980s. WhitereviewedasignificantbodyofpublishedevidenceregardingAEsassociatedwith acupunctureofferinganumericalvalueofAEsassociatedwithacupuncturetreatments. “Accordingtotheevidencefrom12prospectivestudieswhichsurveyedmorethanamillion treatments,theriskofaseriousadverseeventwithacupunctureisestimatedtobe0.05per 10,000treatments,and0.55per10,000individualpatients....Theriskofseriousevents occurringinassociationwithacupunctureisverylow,belowthatofmanycommonmedical treatments.”(3) Laterprospectivestudiesconcludesimilarlythatthevastmajorityofadverseeventsareminor andrequirelittleornotreatment.Parketal.(4)studied2226patientsover5weeksof acupuncturetreatmentsandfoundonly99adverseeventsduringthattime(4.5%).Themost commonwerebleeding/bruising(2.7%)andneedlesitepain(2.7%).Themostlikelymoderately severesideeffectwasnerveinjury(0.31%)describedastemporaryparesthesiawhich disappearedwithin1week.Noseriousadverseeventswereexperiencedbyanypatientsduring thisstudy. 3 Wittetal.(5)observed229,230patientsreceiving,onaverage,tentreatmentsforcommon complaintssuchaspainandallergies.Ofthese,19,726reportedadverseevents(8.6%). Commoneventsagainincludedbleeding/bruising(6.14%),fatigue(1.15%),headache(0.52%), painincludingpainatthesiteofneedleinsertion(1.7%),andaggravationofsymptoms(0.31%). Seriousadverseeventsincluded2casesofpneumothoraxand31casesofnerveinjury (0.014%).31instancesoflocalinfectionsattheacupunctureinsertionpointswerereported (0.014%)and5systemicinfectionswerereported.[IntheWittstudy,85%oftheacupuncture practitionersreceivedonly140hoursofacupuncture-specifictrainingandonly15%hadmore than350hoursofacupuncturetraining.—Ed.] Inthemostrecentcomprehensivereviewofadverseeventsassociatedwithacupuncture, moxibustionandcupping,Xuetal.foundthatbetween2000and2011(12years),“117reports of308AEsfrom25countriesandregionswereassociatedwithacupuncture(294cases), moxibustion(4cases),orcupping(10cases).”(6)Seriousorganandtissueinjurycontinuetobe reportedbutthemajorityoftheacupuncture-associatedAEsareinfections.Clustersof hepatitishadbeenreportedinthepastbutnotasinglecaseisreportedinthisperiod(20002011).Notably,theinfectionshadchangedfromthepastassociationofacupuncturewith hepatitistoskinandsofttissueinfectionssuchasMycobacteriumincludingM.abcessusand Staphylococcusspp.Thisisasignificantreductioninthenumberofinfectionscomparedto earlierreports.TheauthorssuggestedthisreductioninAEsintheU.S.islikelyduetothe introductionofCNTcourse.(Seepage11ofthepaper.)(6) Preventing Acupuncture Needling Adverse Events Althoughrareintermsoffrequency,themostcommonadverseeventsassociatedwith acupunctureareneedlesitebleeding,superficialhematomaandneedlesitepain.Less frequently,faintingduetoacupuncture,tiredness,aggravationofsymptomsandbrokenneedle arereported.Otherpracticeissuesdiscussedherearestuckneedleandforgottenneedle. Bruising and Bleeding Giventhenatureofacupunctureneedling,itisdifficulttopreventallbleedingandbruising.In somecases,someminimalbleedingmaybeexpectedandevenbeneficial.Itispossibleto preventseverebleedingandhematomas.Acupuncturepractitionersmustbeawareofthe vascularanatomyoftheirpatients.Needlingshouldbeperformedsuchthatarteriesandthe largerveinsareavoided.Mildpressureappliedafterneedleremovalwilllimitmostminor bleeding. Specialconsiderationmustbegiventoneedlingofthescalpandthepinna/auricleoftheear. Duetothevascularanatomyofthesestructures,bleedingismorecommon.Acupuncturists shouldapplycleancottonorgauzetopreventbleedingwhenremovingtheneedlesinthese 4 areasandholdthatcottonagainstthescalporpinnaafewsecondslongerthanwhenremoving needlesfromotherbodyparts.Additionally,thescalpand/orpinnashouldbecheckedasecond timeafterallneedleshavebeenremovedasbleedingcanbecomeapparentafteradelaydue tothemicrocirculationinthesestructures. Anticoagulantmedicationsmayincreasethetendencyforbruisingandbleeding.Some supplementsmayalsohavethiseffect.Obtainingacompletemedicationandsupplement history,andanynotedsideeffectsfromtheiruseisimportantinformationtoassessthe potentialsforbruisingorbleeding. Safety Guidelines to Prevent Bruising, Bleeding, and Vascular Injury Critical • Avoidneedlingdirectlyintoarteriesandmajorveinsthrough anatomicalknowledge. • Identifythoseacupuncturepointswhichlieoverornextto majorvessels: o LU9Taiyuan(radialartery) o HT7Shenmen(ulnarartery) o ST9Renying(carotidartery) o ST12Quepen(supraclaviculararteryandvein) o ST13Qihu(subclavianartery) o ST42Chongyang(dorsalispedisartery) o SP11Jimen(femoralartery) o HT1Jiquan(axillaryartery) o LR12Jimai(femoralarteryandvein) o BL40Weizhong(poplitealartery) StronglyRecommended • Palpatesubcutaneousstructures,includingmajorvessels, beforepreparingthesiteforinsertion. • Applycautioninpatientsonmedicationsorsupplementsthat thintheblood,especiallyelderlypatients. • Toavoidsuperficialbleedingorhematoma,applypressureto pointsafterremovingneedles.Reexamineneedledsitesa secondtimeforsignsofbleedingorhematomaandif necessary,applypressure. Recommended • Visualizesurfacevesselsandpalpatethosevessels immediatelyadjacenttoacupuncturepointsbeingneedled duringneedleinsertion. Needle Site Pain/Sensation Needlepainmayoccurasaresultofanumberoffactors.Practitioner-relatedissuesthatmay increaseneedlingsensationincludepoortechnique,needlingsiteswherealcoholremainson theskin,needlingintodenseconnectivetissuesuchastendons,periosteumandperimysium, 5 excessiveneedlemanipulation,orneedlingintoanerve.Patient-relatedconditionsthatmay increaseneedlingsensationincludeanxiety,nervousness,andmovingbodypartsduringneedle insertion.Someneedlesitesensation,including“heavy,”“tight,”“tingling,”orother discomfort,maybeexpectedordesired(deqiresponse).Acupuncturepractitionersshould learnwhichsensationsareexpectedinadeqiresponsesotheycandifferentiatethatfrom nervepain.Studentpractitionersneedtohonetheirskillspriortoworkingonpatientsinorder tolimitthepainassociatedwithpoortechnique.Adequateanatomicalknowledgeand attentiontothesensationsofthetissuesthroughwhichaneedleisproceedingisneededto avoidneedlingintostructuresthatstimulatenervepain.Practitionersshouldlimittheamount ofneedlemanipulationperformedwithasingle-directiontwirlingmotionsoastoprevent subcutaneoustissuefibersandfasciafrombeingtwistedaroundaneedleshaftbeyondthat neededfordesiredtherapeuticresults. Itisalsocommonthatapatientwithchronicpainmaydevelopallodynia(apainfulresponseto anormallyinnocuousstimulus)orhyperalgesia(anincreasedresponsetoapainfulstimulus). Whenapatientpresentswithachronicpainconditionsuchasfibromyalgia,thatpatientmay haveanincreasedsenseofpainfromeitherhyperalgesiaorallodynia.(7,8) Caffeineconsumptionmayalsoaffectpatients’painperceptions.Studieshavefoundthat caffeinemayattenuatetheindividual'sperceptionofpainduringexercise(9,10)andenhance muscularstrengthperformance.(9)Caffeineconsumptionmayalsoheightenanxietyand heightenedanxietyisassociatedwithincreasedperceptionofpain.(11)Anearlystudyfound thatcaffeinecouldblocktheelectroacupuncture-inducedelevationofthenociceptive thresholds.(12)Somepractitionershavealsoreportedthatwhenpatientsconsumecaffeine beforeacupuncture,theymayreportanincreaseinthesensationofneedleinsertion, particularlyinanxiouspatients. Safety Guidelines to Prevent Needle Site Pain Strongly • Ifalcoholisusedtocleantheacupuncturesites,allowalcoholtodry Recommended beforeneedling. Recommended • Visualizeanatomicalstructureswhileinsertingtheneedleandduringall needlemanipulation. • Palpatesubcutaneousstructures,includingtendons,musclesand bones,beforepreparingthesiteforinsertion. • Manipulateneedletodeqiresponseexpectedofaspecificpoint,if desired;avoidnon-therapeuticpainresponse. 6 Fainting WhilefeelingfaintorlightheadedisapossibleAEofacupuncture,moststudiesreportthat morepeoplereportasensationoffaintnessorlightheadednessthanactuallyfaintafterneedle insertion.ThestudybyWittetal.foundthatwhile0.72%ofpatientshavesomesortof vegetativesymptomsonly0.027%actuallyfaint.(5)Whiteetal.intheSurveyofAdverseEvents FollowingAcupuncture(SAFA)studyreportedpresyncopein93patientsbutfaintingofonly6 patients.(13)InthereportbyMcPhersonetal.8patientshadsymptomsoffaintnessbutonly4 actuallyfainted.(14) Manysourcesreportthatpatientsmayexperiencelightheadednessorfaintnessmore commonlyduringthefirsttimetheyreceiveacupuncture,iftheyarenervous,ifthereis excessiveneedlemanipulation,orifthepatientisparticularlyhungryortiredpriortoneedle insertion.(15) FaintingasaresultofacupunctureisreportedmorefrequentlyinareviewoftheChinese literature(16)whencomparedtooutcomesfromstudiesofothercountriesoforigin.This mightbeassociatedwithstrongneedlingstimulationofpatientsinasittingposition,whichcan causeamarkedvasodilatationleadingtoadecreaseofbloodpressure.(2)Feelingfaintcanalso beassociatedwithmoreintenseneedlemanipulation.(17) Safety Guidelines to Prevent Fainting Strongly • Placeafirst-timepatientinthesupinepositionwiththekneesslightly Recommended elevatedforthefirstacupuncturetreatment. Recommended • Explainacupunctureprocedureindetailandanswerallquestions beforeacupunctureneedleinsertiontoallayconcernsand nervousness. • Informpatientsthattheyshouldeat1-2hoursbeforeacupuncture treatments. • Limitneedlemanipulationduringthefirstacupuncturetreatmentor untilclinicalassessmentofthepatient’sresponsetoacupuncturehas beenestablished. Stuck Needle Afteraneedlehasbeeninserted,practitionersmayfinditdifficulttorotate,liftorwithdrawthe needle.Thisismorecommonifapatientmovesaftertheneedleinsertion,ifthepractitioner usesexcessivemanipulationortwirlingoftheneedleinasingledirection,oriftheneedleis insertedtothedepththatitentersintothemusclelayer.Tomanageasituationwherethe needleisstuck,reassurethepatientifheorsheisnervousandaskhimorhertorelaxhisorher muscles;thenmassageorlightlytaptheskinaroundthepointafterwhichtheneedleshould 7 moreeasilyberemoved.Iftheneedleisstilldifficulttowithdraw,askthepatienttoliecalmly forafewminutesorperformanotherneedleinsertionnearbysoastorelaxthemusclesinthe areaofthestuckneedle.Iftheneedleisentangledinfibroustissue,turnitintheopposite directionfromtheinitialneedlestimulation,twirlinguntilitbecomesloosened,thenwithdraw theneedle. Safety Guidelines to Avoid and/or Respond to Stuck Needle Strongly • Identifytherecommendeddepthoftheneedleinsertionfora Recommended particularpointandutilizeproperstimulationtechniquesfor needlesinsertedbelowthesubcutaneouslevel. Recommended • Situatepatientsinaninitialpositionwheretheyarerelaxedand notlikelytoneedtomove.Remindpatientstoremainstillduring acupuncturetreatment. • Ifaneedlethatwasrotatedinonedirectionbecomesstuck,rotate theneedlebackintheoppositedirection. • Stimulatetheareanearastuckneedlewithsimplefinger manipulation,tappingoranotherneedleinsertion;thentryagain toremoveastuckneedle. • Leaveastuckneedleinplaceforafewminutes;thentryagainto removetheneedle. Failure to Remove Needles Since1999,prospectivestudiesidentifyasmallbutpersistentnumberofpatientsinwhich needlesarenotremovedfromthepatientbeforetheyleavethetreatmentroomorclinic. (5,18) Thiserrorbypractitionersmayberelatedtodistractionsfrompatientcare.Someverybasic stepscandramaticallydecreasetheoccurrenceofthispractitionermistake.Retainedneedles maybemorecommonwithinthehairline,onthechestorbackifthereissignificanthair present,onthedorsumofthescalporneckinapatientlyingsupine,orintheearduetothe decreasedvisibilityofthesmallneedlehandlewhenpartiallyorfullycoveredbyhair.Palpating areaslookingforforgottenneedlesmayincreasetheriskofneedlestickinjuries.Documenting thenumberofneedlesinsertedatthetimeofinsertionandthencountinganddocumenting thenumberofneedlesremovedattheendofatreatmentwillhelppreventthisAE.Use countingandproperdocumentationtocheckformissingneedles.However,ifneedlecountsdo notmatch,palpationmaybenecessarybutshouldbedonewithextremecaution. 8 Safety Guidelines for Needle Removal Strongly • Countandwritedownthenumberofneedlesused,including Recommended thosediscardedduetoimproperneedleplacement.Countthe numberofneedleswithdrawnfromthepatient.Confirmthatthe samenumberofneedlesinsertedhasbeenwithdrawnand discarded. Recommended • Documentneedlecountsinthepatientchart. • Keepused/emptyneedlepacketsinthetreatmentroomuntilthe endofthepatient’streatment;confirmallneedlesremovedfrom packagingareaccountedforeitherbyremovalfromthepatient, discardedunusedordiscardedaftercontamination. Aggravation of Symptoms Aggravationofsymptomsoccursasaresultofacupunctureonaninfrequentbutconsistent basis.(6,13,14,18)Aggravationofsymptomsisreportedbothasapotentialadverseeventand asanintendedresponsetotreatment,knownas“MenkenorMengenphenomenon,”or “healingcrisis.”(19)Manytraditionalmedicinetechniquesincludedeliberateaggravationof symptoms(usingahotbathtobringaboutdiaphoresisinthecaseoffever,purgingasa treatmentforgastricdistress,etc.).Practitionersneedtobeclearaboutexpectedoutcomes whenspeakingwithpatientspriortotreatments.Whenaggravationofsymptomsincludes immediatefatigueanddrowsiness,patientsshouldbewarnedaboutdrivingimmediatelyafter treatment.(19) Inflammationmaybeanexpectedresponsetoatreatment.Inflammation,includingcellular responsestostimuli,mayincreasetheinflammatoryresponsethatthenbringsabout improvementofhealth.(20-23) Theroleoftransientinflammatoryresponseasahealing,restorativeprocessiswidely recognized.Withinthetissues,inflammatoryproteinstransduceintracellularsignalstodefine cellularresponsesessentialtocarryingoutthehealingprocesses.Bymanipulatingthe inflammatoryphasesofthehealingprocess,itmaybepossibletoacceleratetissuerepair functions.(22-26)Aggravationofsymptomsfromacupuncturemaybesignalingthishealing response. Ifanaggravationofsymptomsisnottheexpectedoutcomeofanacupuncturetreatment,the acupuncturistshouldevaluatethediagnosisandtreatmentplanforthepatientandassess whetherconsultationwithorreferraltoanotherpractitionerwouldbebeneficial. 9 Safety Guidelines for Aggravation of Symptoms Recommended • Informthepatientofthelikelyeffectsofacupuncture treatment. • Adviseapatientthataggravationofsymptomsmaybea transientoutcomeoftreatment. • Ifunexpectedaggravationofsymptomsoccursasaresultof acupuncturetreatment,considerconsultationwithorreferralto anotherpractitionerforfurtherevaluationpriortoperforming additionalacupuncturetreatments. • Providepatientswithinformationonacupuncturetherapies includingpractitionercontactinformationintheeventtheyhave questionsorconcernsfollowingtreatment. Preventing Rare but Serious Adverse Events (SAEs) Associated with Acupuncture Needling Pneumothorax Pneumothoraxisdefinedastheabnormalpresenceofairinthespacebetweenthelungand thewallofthechest(pleuralcavity),whichpreventslungexpansion.Primaryspontaneous pneumothorax(PSP)occursinhealthypeoplewithoutaprecipitatingeventsuchaslungillness orpuncture.Asmallareaonthesurfaceofthelungthatisfilledwithair(“bleb”)ruptures allowingairtopassintothethoraciccavity.Youngmenwhoaretallbutotherwisehealthyare classicpresentersofprimaryspontaneouspneumothorax.IngeneraltherateofPSPis 7.4/100,000menperyearintheU.S.andlessforwomenat1.2/100,000peryear.(27) Secondaryspontaneouspneumothorax(SPS)isdefinedaspneumothoraxthatoccursasa complicationofunderlyinglungdiseaselikechronicobstructivepulmonarydisease(COPD), cysticfibrosis,sarcoidosisorlungcancerandsoon.(28)50to70%ofSSPisassociatedwith COPDintheliteraturecaseseries.(29) Traumaticpneumothoraxiscausedbypenetratingorblunttraumatothechestsuchasa stabbing,gunshotwoundorsevereblow.Iatrogenicpneumothoraxresultsfromacomplication ofadiagnosticortherapeuticintervention.(30)Pneumothoraxfromacupunctureisanexample ofiatrogenicpneumothorax. Pneumothoraxisariskofacupunctureneedlingoccurringonlytwiceinnearlyaquarterofa milliontreatmentsaccordingtoErnst&White:“Thoseresponsibleforestablishingcompetence inacupunctureshouldconsiderhowtoreducetheserisks.”(30)Yamashitaetal.found25cases ofpneumothoraxinJapaneseliteratureasof2001.(18)ReviewingtheChineseliterature,Zhang etal.found201casesofthoracicorganandtissueAEswithpneumothoraxbeingthemost 10 frequent.(31)MostrecentlyaXuetal.reviewofpneumothoraxesreportedatotalof13 acupuncture-relatedpneumothoraxespublishedfrom2000to2010infromChina,Japan,UK, NewZealand,SingaporeandtheU.S.(6)However,additionalcaseswerereportedinthistime period(32-37)andreportsofcasessincetheXuetal.review(38-43)indicatepneumothorax continuestobeariskofAEinacupuncturepractice. Symptomsofacupuncture-relatedpneumothoraxcanpresentimmediatelyuponpenetrating thelungorhourslater.Symptomsmayincludedyspnea(shortnessofbreath)onexertion, tachypnea(increasedrespiratoryrate),chestpain,drycough,cyanosis,and diaphoresis/sweating.(44)Acupuncturepractitionerscanbeunawareofhavingcreateda pneumothoraxorwhatpointorpointswereimplicatedbecausepatients,bynecessity,report toanemergencydepartment,andtheinformationregardingpractitionerorpointsusedisnot recorded. Patientsatincreasedriskforpneumothoraxfromacupunctureincludecigarettesmokersand marijuanasmokersandthosesufferingfromlungdiseasesuchaschronicasthma,emphysema andCOPDaswellaspatientswithlungcancerorwhoareoncorticosteroids.(35)Patientswith Marfansyndrome,homocystinuria,andthoracicendometriosisarealsomorepredisposedto PSPthanothers.(30) Patientswithchroniclungdiseasewillhavelossofmusclemass;theirmusculaturethinsand “barrels”becauseventilatorymusclesarechronicallyoverloadedandoverworkedfromairflow obstructionandhyperinflation. Pneumothoraxisalsoacomplicationofdryneedling.Thiscanbeseenwiththepatientwho suffersapneumothoraxduringademonstrationofdeepdryneedling(DDN)totreatthe iliocostalismuscle.(45) Theprimaryareasassociatedwithacupunctureordryneedling-inducedpneumothoraxarethe regionsofthethoraxincludingtheuppertrapezius,thoracicparaspinal,medialscapular,and subclavicularareas.(44) Itiscriticalthatamedicalhistoryestablishesorrulesoutincreasedacupuncture-pneumothorax riskfactorssuchassmoking,includingmarijuanasmoking,and/orhistoryorpresenceoflung diseasesuchaschronicasthma,emphysema,COPD,lungcancerand/ortakingcorticosteroids. Itisalsocriticaltoassessthephysiqueofapatient.Averytall,thinpatientoronewithatrophy ormusclemasslossfromhyperinflationwillhaveashallowsurfacetolungdepth,increasing theriskofpenetratingthelungresultinginpneumothorax.Needlingshouldbelimitedto superficialpenetrationoverthechest,back,shoulderandlateralthoracicregion,nodeeper thanthesubcutaneoustissue.Itisalsostronglyrecommendedtouseneedlesthatarenot 11 longerthansafeneedlingdepthatanythoracicregionareaincludingtheHuatuojiajipoints, bladderchannel,andanyintercostalspace. Safeneedlingdepthisrecommendedat10-20mm;lessthanthefacewidthofaU.S.nickel,20centEurocoin,Canadian25-centpieceorEnglish20pence.Ratherthanneedlingata perpendicularangle,itisstronglyrecommendedtoneedleatanobliqueangle.Thisalso ensuresthatneedleswillnottraveldeeperintothebody.Placingablanketoverneedlesinthe thoracicareacausedneedlestobeinserteddeepenoughtocauseapneumothoraxinone reportedcase.(46)Obliqueneedleplacementwouldpreventthiscomplication. CareshouldbetakenwhenneedlingtheGB21(Jianjing)andtheuppertrapeziusmusclesince theapexofthelungextends2–3cmabovetheclavicularline.(44)Incorrectneedlingofthis areahasbeenassociatedwithpneumothorax. PointsmostfrequentlyassociatedwithpneumothoraxeventsintheChineseliterature(31)are: Jianjing(GB21;30%),Feishu(BL13;15%),Quepen(ST12;10%),andTiantu(Ren22;10%); infrequenteventsoccurredatGanshu(BL18),Jiuwei(Ren15),Juque(Ren14),Jianzhen(SI9), Quyuan(SI13),andDingchuan(EX-B1). Peuker&GrönemeyeridentifyriskpointsST11(Qishe)andST12(Quepen),LU2(Yunmen),ST 13(Qihu),KI27(KI22-27),andST12-18.(47)However,anypointsneedledinthethoracicbody regionriskpenetratingthelung,includingthefront,back,orlateralbody,thelowerneck, shoulderandscapularregionaswellasthechest,ribsandjustbelowtheribsdependingonthe positionofthepatient. Safety Guidelines to Avoid Pneumothorax Critical • Obtainamedicalhistoryfromapatientregardinglungfunction,lung diseasesandsmokinghistorybeforeneedlingonthechestorback. • Assessphysiqueofapatient.Averytall,thinpatientoronewith atrophyormusclemasslossfromhyperinflationwillhaveashorter depthofsurfacetolung,increasingtheriskofpenetratingthelung resultinginpneumothorax. • Safeneedlingdepthtoavoidpneumothoraxonmostpatientscanbeas littleas10-20mm. • Limitthedepthofacupunctureneedleinsertiontothesubcutaneous layerandinitialperimysiumoftheintercostalmuscles. Strongly • Needleatanobliqueangleratherthanataperpendicularangleinthe Recommended thoracicbody(fromthetopoftheshoulderstotheT-10areaonthe back,orfromthetopoftheshoulderstothexiphoidlevelonthechest). Thisalsoensuresthatneedleswillnottraveldeeperintothebodyfrom theweightofasheetorgownusedtocoverthepatient. • Limitverticalmanipulationofneedlesonthechestorback. 12 • • Recommended • • Donotcupoverneedlesonthethoraxintheareaofthelungstoavoid tissuecompressionthatcancauseneedlepenetrationtointernal organs. Ifthereareindicationsorsuspicionsthatanorganmayhavebeen punctured,emergencytransportshouldbecalledtotakethepatientto anemergencymedicalfacility. Avoidusingneedlesthatarelongerthanthesafeneedlingdepthfora particularbodyarea. OnemethodtoreduceriskatGB21(Jianjing):Whileisolatingandlifting thetrapeziusmusclewithapincergripusingtheoppositehand,needle acrossthemuscleatGB21(Jianjing),takingcaretodirecttheneedle obliquelyandnotinferiorlytowardthelung. Injury to Other Organs Injurytointernalorgansisareportedseriousadverseeventofacupuncture.(1,6,31)Heart injuryisanextremelyrarecomplicationofacupuncture;however,fatalitieshavebeen reported.Xuetal.(6)reportfivecasesofheartinjuryincludingtwoofcardiactamponadeand threeotherheartinjuriesduringa12yearperiod.ErnstandZhangreport26casesofcardiac tamponadewith14fatalitiessince1956;howevercasesofself-injuryandaccidentalinjuryare includedalongwithcardiacinjuryduringacupuncture.(48)Asanexample,acasethatisstill sometimescitedasan“acupuncturefatality”resultedfromaself-inflictedsewingneedleand notfromactualacupuncturepractice.(49)OfthecasesreportedbyErnstandZhang,onlyoneis ofaneedlepenetratingasternalforamen,threewereself-treatmentwhenthegoalof treatmentwasunclear.Themajorityofcasesinvolvedmigrationofneedlesorpartsofneedles brokenoffinthebody.(48)Suchembeddedneedlesarenotpartofmodernacupuncture. Excessiveneedlelength(60mm)isdescribedascontributingtoanothercasereportandmust beavoided.(50) Althoughrare,theriskofsternalforamenmustbeconsidered.Insertionthroughacongenital defectinthesternumappearstobethemechanismofinjuryintwoofthecasesreportedby ErnstandZhang.(48,51,52)InacasereportedfromAustriain2000,anemaciated83-year-old womanwasneedledatRen17(Shanzhong).Theneedlewasinsertedbyanexperienced acupuncturistthroughasternalforamen.Symptomsappearedwithin20minutes.Thereport describesthatthe30mmneedlemayhavebeeninsertedperpendicularlyinanemaciated patient.(52)PeukerandGrönemeyer(53)reportthattheincidenceofasternalforamenatthe levelofthefourthintercostalspaceexistsin5-8%ofthepopulation.Thisdemographicis confirmedinrecentCTstudies.(54)Palpationcannotrevealthedefect(53)andthereisno correlationbetweenthedepthofsubcutaneousfatanddistancetoavitalorgan.(54)Whilethe placementofinternalorgansdirectlyunderasternalforamenandthedepthfromskintoorgan 13 varied,CTscanssuggestthat25mmisthemaximumsafeinsertiondepthtoavoidinjurytothe heart.(54) Inadditiontodepth,angleofinsertionwhenneedlingthechestmustbeconsidered.Obliqueor transverseneedlingonpointslocatedonthechestandavoidinganupwarddirectionatRen15 (Jiuwei)iscriticaltopreventheartinjury. Symptomsofcardiactamponadeincludeanxiety,restlessness,lowbloodpressureand weakness,chestpainradiatingtotheneck,shoulder,backorabdomen,chestpainthatgets worsewithdeepbreathingorcoughing,problemsbreathingorrapidbreathing,discomfortthat isrelievedbysittingorleaningforward,faintingorlight-headedness,palpitations,drowsiness, and/orweakorabsentperipheralpulses. TherearereportsintheWesternliteratureofinjurytootherinternalorgansbutmostarenot recent.Zhangetal.(31)reviewseriousAEsfromtheChineseliteratureandreport16casesof abdominalorganandtissueinjuryincludingperforationsofthegallbladder,bowels,and stomachwithperitonitis.Injurywasattributedtoneedlingtoodeeply;thepointscitedareST 25(TianShu),Ren12(Zhongwan),andLR14(QiMen)inthetreatmentofabdominalpain, appendicitisorcholecystitis. Reportingonanacupunctureneedlethatremainedinalungfor14years,Leweketal.reviewed 25casesofmigrationofneedlefragmentsandtheyincludetotheliver,pancreas,stomach, colon,breast,kidney,andmusclesandspinalcord.(55)Additionally,therearecasereportsof foreignbodystonesformedaroundneedlefragmentsintheureter(56)andbladder.(57)As mentionedabove,suchembeddedneedlesarenotpartofmodernacupuncture. Beforeadministeringacupuncture,specialcareshouldbetakentoexaminethepatientforany suspectedorganenlargement.Abnormalchangesintheinternalorgansmaycomefroma varietyofdiseases.Changesinheartsizemaybearesultofchronichypertensionand congestiveheartfailure.Hepatomegalymaybearesultofanumberofdiseasesincluding alcoholism,chronicactivehepatitis,hepatocellularcarcinoma,infectiousmononucleosis,Reye’s syndrome,primarybiliarycirrhosis,sarcoidosis,steatosis,ortumormetastases.Splenomegaly maybecausedbyinfectionssuchasinfectiousmononucleosis,AIDS,malaria,and anaplasmosis(formerlyknownasehrlichiosis);cancers,includingleukemiaand bothHodgkinsandnon-Hodgkinslymphoma;anddiseasesassociatedwithabnormalredcells suchassicklecelldisease,thalassemia,andspherocytosis. Puncturingtheliverorspleenmaycauseinternalbleeding,althoughsevereresponsesarerare andnocasesofliverorspleeninjuryhavebeenreportedinEnglishinthepasttwelveyears.(6) Symptomsofsuchorganinjuryincludeabdominalpain,rigidityoftheabdominalmuscles, 14 and/orreboundpainuponpressure.Puncturingthekidneymaycausepaininthelumbar region,tendernessandpainuponpercussionaroundthekidneyregion,andbloodyurine. Central Nervous System Injury Acupuncture-relatedcentralnervoussysteminjuriesarereportedmoreofteninEastern literature.(3,53)Xuetal.(6)reportninecasesofcentralnervoussysteminjuryoverthe12year periodreportedinthatdocument.Liketheheartinjurycasesreportedabove,afewspinalcord injurieswerecausedbymigratingbrokenneedles.Deepneedlingmayalsocausedamagetothe spinalcord.AccordingtoPeukerandGrönemeyer,“Thedistancefromthesurfaceoftheskinto thespinalcordortherootsofthespinalnervesrangesfrom25to45mm,dependingonthe constitutionofthepatient.Deepneedlingofpointsoftheinnerlineofthebladdermeridian (BL11to20)wasparticularlylikelytocauselesionsofthespinalcordorthespinalnerveroots.” (53) Safety Guidelines to Avoid Organ and Central Nervous System Injury Critical • Observesafeneedlingdepthandanglestoavoidcardiacinjury. o Toavoidpenetrationatasternalforamen,useanobliqueangle toneedleonthesternum. o Limitthedepthofacupunctureneedleinsertiontothe subcutaneouslayer. • NeedlingDu22(Xinhui)inaninfantisprohibited. Strongly • Allpatienthistoriesshouldincludeinformationaboutcurrentorpast Recommended diseasesthatmightleadtoachangeinthesizeoftheorgans. • Donotcupoverneedlesontheabdomentoavoidtissuecompression thatcancauseneedlepenetrationtointernalorgans. • Limitverticalmanipulationoftheneedlesontheabdomen. Recommended • Ifthereareindicationsorsuspicionsthatanorganmayhavebeen punctured,emergencytransportshouldbecalledtotakethepatientto anemergencymedicalfacility. • Avoidusingneedlesthatarelongerthanthesafeneedlingdepthforany givenbodyarea. Traumatic Tissue Injury Peripheral Nerves Peripheralnerveinjuriesarereportedinfrequently(53)andmayincludeaneedlefragment withinthecarpaltunnelcausingmedianneuropathy,mediansensoryneuropathyfromneedle injury,(59)peronealnervepalsy,(60)andinonecaseresultingindropfoot.(61)Fourcasesof peripheralnerveinjuryarereportedinChina,threerelatedtoneedlingofLI4(Hegu)onthe hand.Includedinthisreportwastheobservationthataforcefulneedlemanipulationatthis 15 pointcancauseperipheralnerveinjury.(53)AcaseofBell’spalsy24hoursafteracupunctureis reportedbyRosted&Woolley.(62) Blood Vessels TwocasesofvascularinjuryarereportedintheU.S.:acuteintracranialhemorrhageinapatient givenacupunctureforneckpain(63)andcerebrospinalfluidfistulainapatienttreatedforlow backpainwithembeddedneedles.(64) Acupunctureneedlenickstoacapillaryorveinresultinginminorbleedingorsuperficial hematomaarenotuncommon.Injuriestobloodvesselsresultinginmoreserious complications,suchascompartmentsyndrome,deepveinthrombosis,poplitealartery occlusion,aneurysmandpseudoaneurysmaswellasarterialinjuryarerarebutarereported. (4,65)Morerecentlyaseriousthighhematomaresultedfromacupuncturetreatmentinan82year-oldwomantakingwarfarin.(66)HerINRwasstableat2.4;itappearstheadditionalrisk factorsinthiscaserelatedtodeepneedlingandtheageofthepatientcomplicatedby anticoagulanttherapy. Safety Guidelines to Avoid Traumatic Tissue Injury Critical • FollowSafetyGuidelinestoPreventBruising,BleedingandVascular Injury. Strongly • Toreduceriskofperipheralnerveinjury,avoidaggressiveneedle Recommended manipulationinanatomicalareaswitharecordofrisksuchasthehand andwrist,ankleandfibularhead. • Ifapatientexperiencesacuteseverepainfromneedlingapointdonot continuetomanipulatetheneedlebutwithdrawtoashallowerdepth orremoveitentirely. Infections Infectionsmaybelocalorsystemic,duetoanautogenoussource(thepatient)orbeacross infection(fromthepractitionerorothers).OneinthreepeoplearecarriersofStaphylococcus aureus,and1in10isacarrierofMRSA.Likewise,Mycobacteriummaybepartofcommonskin flora.Acarriermayhavenosymptomsorindicationstheyareacarrierunlesstheyaretested, typicallywithswabsoftheskin,noseormouth.S.aureusorMRSAcaninfectwoundsand preventhealing,causebloodinfection(septicemia),orinfectorgans,bone,heartvalve/liningor lung,and/orcreateaninternalabscess.Patientsareoftenhospitalized,mayrequiresurgery, monthsofIVantibioticsandmayexperiencelifelongsequelaeorevendeath. Recentreportsofacupuncture-relatedinfectionareofskinandsofttissuesuchas mycobacteriumincludingMycobacteriumabscessusandStaphylococcusaureusincluding MRSA.Ofthe239casesreportedfortheperiodof2000-2011,193weremycobacterium infection.Thesourceofmostoftheseinfectionswastracedtoreuseofimproperlydisinfected 16 needlesortherapeuticequipmentoruseofcontaminateddisinfectantorgelusedforrelated procedures.(6) Whileinfectionsassociatedwithacupunctureneedlingarearareoccurrence,anydisruptionof thenormalbarrierstoinfection,suchaspuncturingthroughtheskinandepidermalflora,can allowapathogentoenterthebody.Thosewithareductioninnormalimmunefunctionmay thennotrespondadequatelytothepathogen,allowinganinfectiontostart.Reductionin normalimmunefunctionmaytakeplaceduetoanumberoflifesituationsanddiseasessuchas inpersonswhohavesignificantstress,usecorticosteroidsandotherimmunesuppressing drugs,orwhohavecancerorimmunesuppressingdiseasessuchasAIDS.Asotherconditions anddiseasesmayalsocompromiseimmunefunction,acupuncturepractitionersshouldtake caretouseCleanNeedleTechniquewithallpatientstopreventinfections. Careshouldbetakentolimiteventherarebutmeasurableriskofinfectionassociatedwith needling.TheCleanNeedleTechniquediscussedinPartIIofthismanualisdesignedtolimit exposureofpatientsfrombothautonomousandcrossinfections,andtolimitexposureof practitionersandtheirstafffrominfectionswhicharepartofanymedically-relatedpractice. SeePartIVforamorethoroughdiscussionofhealthcareassociatedinfections. Safety Guidelines to Prevent Infection Critical • FollowCleanNeedleTechnique. • FollowStandardPrecautions:Considerallpatientsasiftheyarecarriers ofbloodbornepathogenssuchasHepatitis(HBV),HepatitisC(HCV), HIV,StaphorMRSA. • FollowSafetyGuidelinesforHandSanitation. • FollowSafetyGuidelinesforPreparingandMaintainingaCleanField. • FollowSafetyGuidelinesforSkinPreparation. • Useonlysingle-usesterileneedlesandlancets. • Checkneedlesbeforeuseforsterilizationexpirationdates,breaksinthe packagingoranyevidencethatairorwaterhasenteredtheneedle packagingpriortouse. • Wearglovesorfingercotsorotherwisecoverupanyareasofbroken skinonthepractitioner’shands. • Maintaincleanprocedureatalltimeswhilehandlingneedlesbefore insertion.Ifneedlesortubesbecomecontaminated,theyshouldbe discarded. • Donotneedleintoanyskinlesion.Acupunctureneedlesshouldnever beinsertedthroughinflamedorbrokenskin. • Useonlysterileinstrumentswhenbreakingtheskinsurface(needles, plumblossoms,andlancets). • Immediatelyisolateusedneedlesinanappropriatesharpscontainer. 17 • • • • Strongly • Recommended • • • Recommended • • • Whenusingamulti-needlepackofsterilizedneedles,oncethe packagingisopenedforonepatientvisit,anyunusedneedlesmustbe discardedproperlyandnotsavedforanotherpatienttreatmentsession. Followguidelinesfordisinfectingreusableadjuncttherapytoolsafter everyuse. Usenewtablepaper(orcleanlinenifusingclothcoverings)oneach treatmenttableforeachnewpatientvisit. Wipedowneachtreatmentchairortablewithadisinfectantsolutionor disinfectantclothbetweeneachpatientvisit. Guidetubesmustbesterileatthebeginningofthetreatmentandmust notbeusedformorethanonepatient. Whenneedlestabilizationisneeded,thepractitionershouldusesterile cottonorsterilegauzetostabilizetheshaftoftheneedle. Ifyoustickyourselfwithausedorcontaminatedneedle,seekmedical advice. Cleanalltreatmentroomsurfaceswithapproveddisinfectantsdaily. Whileitisacceptabletopalpatethecleanedareaofskintoprecisely locatetheacupuncturepointaftertheskiniscleanedandbefore needling,thepractitionershouldnottracefingersorhandsacrossa wideareaofskintolocateanacupuncturepointaftertheskinis cleanedandbeforeneedling. Whendesiredafterneedlewithdrawal,applypressuretothe acupuncturepointwithcleancottonorgauze. Cleanallofficecommonuseareaswithanapproveddisinfectantdaily. Broken Needle Theadventofthesingle-usedisposablesterilestainlesssteelacupunctureneedlehas significantlyreducedthepreviouslyuncommonbutoccasionallyoccurringbrokenneedle. Metalsaremadebrittlebytheheatingandcoolingassociatedwithautoclavesterilization procedures;moreover,thequalityofmetalmaterialsusedforneedleshasadvanced.With single-useneedles,theriskofthebrokenneedleapproacheszero.However,manufacturing errorsmaystillallowforsucheventsandthepractitionershouldbeawareofhowtohandle suchasituation.NeitherWhite(3)norMcPherson(14)reportsanybrokenneedlesduringtheir prospectivestudies.Wittetal.reports2brokenneedlesoutof229,230patientstreated.(5) Abrokenneedlemayoccurif:(a)therearecracksorerosionsontheshaftoftheneedle, especiallyatthejunctionwiththehandle;(b)thequalityoftheneedleispoor;(c)thepatient haschangedpositiontotoogreatanextent;(d)thereisastrongspasmofthemuscle;(e) excessiveforceisusedinmanipulatingtheneedle;(f)theneedlehasbeenstruckbyanexternal 18 force;or(g)abentneedlehasbeenrigidlywithdrawn.Inanerawhenonlysingle-use disposableneedlesshouldbeused,needlebreakagehasbecomeahighlyunlikelyoccurrence. Tomanageabrokenneedle,theacupuncturistshouldremaincalmandadvisethepatientnot tomovesoastoavoidcausingthebrokenpartoftheneedletodrawdeeper.Ifapartofthe needleisstillexposedabovetheskin,removeitwithforceps.Ifitisonthesamelevelwiththe skin,pressthetissuesaroundthesitegentlyuntilthebrokenendisexposed,thentakethe needleoutwithforceps.Ifitiscompletelyundertheskin,seekmedicalhelpimmediately.Do notcutthefleshtogetaccesstotheneedle.Removeallotherneedles.Callforemergency transporttoahospitalormedicalfacilitywhereaphysiciancanremovetheneedleshaft. Themosteffectivewaytopreventabrokenneedleiscompliancewithsingle-usedisposable needles.Ifneedlesorpackagingappeardefectiveinanyway,donotusethoseneedlesfor patientcare.Disposeofthedefectiveneedleinasharpscontaineranduseanothersterile needle.Usetheappropriateneedlesizeandlengthforthelocationandtechniquetobeused. Safety Guidelines to Prevent Broken Needles Critical • Inspectneedlefordefectsinmanufacturingbeforeuse. Strongly • Useonlysingle-usesterilizedneedles. Recommended • Neverinsertaneedletothehandle. 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NedTijdschrGeneeskd.2002;146(4)(January26):172-175. 35.SuJW,LimCH,ChuaYL.Bilateralpneumothoracesasacomplicationofacupuncture. SingaporeMedJ.2007;48(1)(January):32-33. 36.TerraRM,FernandezA,BammannRH,CastroACP,IshyA,JunqueiraJJM.[Pneumothorax afteracupuncture:clinicalpresentationandmanagement].RevAssocMedBras. 2007;53(6)(November):535-538. 37.ZhaoD,ZhangG.[Clinicalanalysison38casesofpneumothoraxinducedbyacupunctureor acupointinjection].ZhongguoZhenJiu.2009;29(3)(March31):239-42. 38.CummingsM,Ross-MarrsR,GerwinR.Pneumothoraxcomplicationofdeepdryneedling demonstration.AcupunctMed.2014;0(Oct3):1-3. 39.DingM,QiuY,JiangZ,TangLJC.Acupuncture-associatedpneumothorax.JAltern ComplementMed.2013;19(6)(Jun):564-8. 21 40.HamptonD,KanekoR,SimeonE,MorenA,RowellS,WattersJ.Acupuncture-related pneumothorac.MedAcupunct.2014;26(43):241-245. 41.HarrriotA,MehtaN,SeckoM,RomneyM.Sonographicdiagnosisofbilateralpneumothorax followinganacupuncturesession.JClinUltrasound.2014;42(1)(January):27-9. 42.SmithP,PerkinsM.Gettothepoint:A44-year-oldfemalepresentstotheEmergency Departmentwithchestpain.Chest.2014;146(4_MeetingAbstracts)(331A)(Oct28). 43.TagamiR,MoriyaT,KinoshitaK,TanjoK.Bilateraltensionpneumothroaxrelatedto acupuncture.AcupunctMed.2013;31(2):242-4. 44.McCutcheonL,YellandM.Iatrogenicpneumothorax:safetyconcernswhenusing acupunctureordryneedlinginthethoracicregion.Physicaltherapyreviews. 2001;16(2):126-32. 45.CummingsM,Ross-MarrsR,GerwinR.Pneumothoraxcomplicationofdeepdryneedling demonstration:SupplementaryDataOnlineVideo.AcupunctMed.2014; http://aim.bmj.com/content/32/6/517/suppl/DC1;AccessedJan18,2014(Oct3). 46.MelchartD,WeidenhammerW,StrengAetal.Prospectiveinvestigationofadverseeffects ofacupuncturein97733patients.ArchInternMed.2004;164(1)(January12):104-105. 47.PeukerE.Casereportoftensionpneumothoraxrelatedtoacupuncture.AcupunctMed. 2004;22(1)(March):40-43. 48.ErnstE,ZhangJ.Cardiactamponadecausedbyacupuncture:areviewoftheliterature.IntJ Cardiol.2011;149(3)(June16):287-289. 49.SchiffA.Afatalityduetoacupuncture.MedTimes(London).1965;93:630-1. 50.HerA-Y,KimYH,RyuS-M,ChoJH.Cardiactamponadecomplicatedbyacupuncture: hemopericardiumduetoshreddedcoronaryarteryinjury.YonseiMedJ.2013;54(3) (May1):788-790. 51.HalvorsenTB,AndaSS,NaessAB,LevangOW.Fatalcardiactamponadeafteracupuncture throughcongenitalsternalforamen.Lancet.1995;345(8958)(May6):1175. 52.KirchgattererA,SchwarzCD,HollerE,PunzengruberC,HartlP,EberB.Cardiactamponade followingacupuncture.Chest.2000;117(5)(May):1510-1511. 53.PeukerE,GrönemeyerD.Rarebutseriouscomplicationsofacupuncture:traumaticlesions. 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Moxibustion Safety/Adverse Events – A Review of the Literature InmodernU.S.AOMpractice,moxibustionismostoftenusedasacomplementtothepractice ofacupuncture.Moxibustionistheheatingofapointontheskinutilizingmoxainvarious forms.ThemostcommonlyusedherbmaterialusedformoxacomesfromArtemisiavulgaris, alsocalledmugwort.Practitionersuseanumberofdifferentmaterialsformoxibustion, includingvariousshapesofmugwortincludingloosemoxa,varioussizesofmoxacones,andthe morecommonlyusedmoxaroll,boththetraditionaltypeandthe“smokeless”type. Practitionersmayutilizemoxaconesormoxasticksforwarmmoxibustion,warmcylinder moxibustion,and,incertaincases,burning/scarringmoxa. MostTCMpractitionersutilizemoxibustiontherapyalongwithneedlingacupuncturepointsfor awiderangeofdisorders.AgeneraloverviewcanbefoundinthetextChineseAcupunctureand Moxibustion.(1)Theuseofmoxibustioniswidespreadandstudieshavereportedeffectiveness inawidevarietyofconditionsfrommusculoskeletalcomplaints,gastrointestinalsymptoms, gynecologicdisorders,breechpresentations,strokerehabilitation,andcomplementarycarefor cancersymptoms,tothetreatmentofinfectiousdiseases.(2)Licensedacupuncture practitionershaveextensivetraininginthemanyandvariedusesofmoxibustiontherapy. Therehavebeenfewretrospectivestudiesofthesafetyofdirectandindirectmoxibustion treatment.In2010Parketal.(2)attemptedtoreviewthemedicalliteratureandprovidean overviewofadverseeventsassociatedwithmoxibustion.Whiledatawaslimited,theclinical trialstheyreviewedidentified“rubefaction,blistering,itchingsensations,discomfortdueto smoke,generalfatigue,stomachupsets,flare-ups,headaches,andburns”asadverseevents.In general,theyconcludedthatpractitionersshouldbepreparedtodealwithburns,allergic reactionsandinfectionsasprobableadverseeventsofmoxatherapies.Inthe2013report,Xu etal.(3)reportAEsassociatedwithmoxibustionwerefoundtobeprimarilybruising,burns,and cellulitis. ProspectivestudiesofmoxibustiontherapyalonearenotavailableintheEnglishliterature.In 1999,aJapanesestudy(4)failedtodifferentiatebetweenadverseeventsassociatedwith acupunctureneedlingandthatassociatedspecificallyfrommoxibustion.Theirconclusionwas that“seriousorsevereadverseeventsarerareinstandardpractice.” Whilepractitionerscanprobablyunderstandtheassociationofburnswithanytypeofheat therapy,thepossibilityofinfection,nauseaorallergiesassociatedwithmoxatherapyisless self-evident.Infectionscanbetheresultofburnsthatdisruptthenormalfunctionoftheskin andsubcutaneousbarrierstoinfection.Onecaseassociatedwithscarringmoxatherapy identifiedanepidural(cervical)abscess,cellulitisandosteomyelitisinadiabeticwomanafter 24 repeateddirectmoxatherapy.(5)Burnsfromanytherapeuticmodalityaremorecommonin diabeticpatients.(6) Infectionsassociatedwithmoxibustionmayalsobearesultofotherpracticesthatareused alongwiththemoxasuchasneedlingorscarringtherapies.(2) Allergiestothemoxasmoke,orresponsetothevolatilesubstancessuchasborneolinthemoxa smokemaycreatenauseaorallergicreactions.“Undernormaloperatingconditionsneither volatilenorcarbonmonoxide[associatedwithmoxasmoke]wouldpresentasafetyhazard.”(6) Withproperventilation,thetoxicityofmoxasmokeisprobablyminimal.(7,8) ChinesemedicalliteraturealsoreportsonlyminimalAEsassociatedwithmoxibustion techniques.AfewreportsintheChineseliteratureontheadverseeventsassociatedwith moxibustionmainlydetailsomelocalAEssuchasburningoftheskin,andskinallergies associatedwithmoxibustionpractice.(9) Effectsofmoxibustiononchemicalparametersofhealtharelimited,suggestingthatexceptfor AEssuchasburns,moxibustionisarelativelysafeprocedure.Inastudypublishedin2011, researchersfoundthatindirectmoxibustionisgenerallyconsideredsafe.(10) Onecasereportofhepatitisinthemedicalliteraturewasinaccuratelyidentifiedasbeing associatedwithmoxause.Thisreportstatedthatapatient“presumablyacquiredhepatitisC throughsharingofinfectedknivesduringtheprocessofscarificationorthroughmoxibustionif itinvolvedtheuseofneedles...”(11) Contraindicationsfordirectorscarringmoxibustioninvolvethesensitiveareasofthebody, suchastheface(duetothepossibilityofburns,andalsotoavoidgettingsmokedirectlyinto theeyesornose),thenipplesandthegenitals(duetosensitivity)andwithinthehairline(as haircanburn).O'ConnorandBenskyinAcupuncture:AComprehensiveText(12)reinforcethe needtoavoidtheheadandfaceformoxibustionbyreportingthatancienttextsadvisedcaution orprohibitionwhenapplyingmoxibustiontothefollowingpoints:Shangxing(DU 23),Chengqi(ST1),Sibai(ST2),Touwei(ST8),Jingming(BL1),Zanzhu(BL2),Sizhukong(SJ 23),Heliao(LI19),Yingxiang(LI20),andRenying(ST9). Preventing Moxibustion Adverse Events Burns Practitionersperformingmoxibustionshouldavoidcausingburns(exceptwhenperforming scarringmoxibustion)andbeawarethateachpersonhasadifferenttolerancetoheat.Itis importanttobeespeciallycarefulwithpersonswhohaveconditionswheresensitivityoflocal 25 nervesmaybediminished,suchasinneuralinjury,diabetesmellitus,orpathologyresultingin paralysis,becausesuchpersonsareespeciallysusceptibletoburns. Whenusingindirectmoxaontheneedle,besuretoprotectthepatient’sskinfromanyfalling moxaorashes.Ifusingdirectmoxaorscarringtechniques,itissuggestedthatthepractitioner fullyexplainthetechniquetothepatientandaskthepatienttosignaninformed,written consentformbeforeusingthistechnique. Ifapatienthasbeenburned,infectionistheprimaryconcern.Iftheburnisaverysmallfirst degreeburn,currentpracticeistoruncoolwaterovertheburn(neverice),andthenapply sterilegauzesecuredtotheskinwithmedicaltape.Over-the-counterburncreamsmayalsobe usedasperthepackagedirections.Ifaburnissevere,orifthereisaconcernwithinfection, referthepatienttoaphysician. Burnstothepractitionercanalsooccurwhenproperprecautionsarenottaken.SeePartIIIfor detailsofsafemoxapractices. Safety Guidelines to Prevent Moxa Burns Critical • Takeacarefulpatienthistorytoidentifyneuropathiesorother conditionsthatmightlimitapatient’sresponsetopainorthe abilitytosenseheat. • Duringmoxatherapythepractitionermustremainintheroom atalltimes. • Avoiddirectmoxibustionontheface,withinthehairline,orin otherhighlysensitiveareas. • Anticipateandshieldapatientfromfallingashwhenutilizing needle-topmoxa. Strongly • Thepractitionershouldnotattempttomulti-taskduringthe Recommended applicationofmoxatherapies. • Thepractitionershouldmonitortheskintemperatureand amountofheatgeneratedbymoxa,andnotrelysolelyon patientfeedbackaboutheatsensationswhenutilizinganyform ofmoxibustion. • Roomsinwhichmoxaistobeusedshouldbeequippedwith Recommended waterandafireextinguisher. Secondary Infection from Moxa Burns Infectionsassociatedwithmoxibustionaresecondaryadverseeventsrelatedtoburns.Burn. Burnpreventioniscritical.Whenmorethan1cmofskinisinvolvedwithaburn,practitioners needtoassesstheamountofskindamageandconsiderareferraltoamedicalpractitionerfor treatment. 26 Safety Guidelines to Prevent Secondary Infection from Moxa Burns Critical • Preventmoxaburns. • Payingcloseattentiontopatientcomfortandskinreactions duringalltreatmentscanpreventseconddegreeburns,which aremorelikelytobecomeinfectedduetodepthoftissue damage. • FollowSafetyGuidelinesforHandSanitationbeforeandafter treatinganyburnsaspotentiallyinfectiousmaterialmaybe present. • Washallburnsthatdooccurwithcoolrunningwater immediately. Strongly • Measureandchartthediameterandlocationofanyburns Recommended occurringasaresultofmoxatherapies. Recommended • Assesstheamountofdamageandrefertoawesternmedical practitionerifneeded. Nausea or Other Adverse Reactions to Moxa Smoke Bothpractitionersandpatientsmayhaveareactiontoinhalingmoxasmoke.Suchreactionsare usuallytemporaryandcanbeminimizedbyproperventilationofthetreatmentroom. Safety Guidelines to Prevent Adverse Reactions to Moxa Smoke Critical • Roomsinwhichmoxibustionisperformedmusthaveproper ventilation. Strongly • PractitionersshouldutilizeairfilterunitswhichincludeHEPA Recommended filterswhenperformingmoxibustion. Recommended • Considerotheroptionsfortreatmentinsteadofburningmoxa forpatientswithahistoryofsignificantasthmaorother reactionstosmoke. Other Heat Therapies InfraredandTDP(TedingDianciboPu)lampsareusedbypractitionerstowarmthepatient,or specificareasofapatient.TDPlampsconsistofaheatingelementonanadjustablearmthat maybeplacedabovethepatientandisusedtowarmthepatient’sskin.Theheatingelementin thelampmayreachatemperaturethatwillburnapatient.ItisimperativethataTDPlampbe monitoredcarefullywheninuse,andthatunexpectedmovementsoftheheatingelementare prevented.Somelampsmayslowlylowerduringthecourseofatreatment,resultinginaburn overtheareabeingwarmed.Mechanicalfailureoftheheatlampitselfmayoccurduring treatmentallowingthearmandheatingelementtorapidlydescendnearorontothepatient’s skin.Topreventsuchaburn,TDPlampsshouldbecarefullycheckedfordefectsbeforeuse. DefectiveordysfunctionalheatingdevicesincludingTDPlampsshouldnotbeusedinanyclinic. Intheeventofsuchaburn,theinjuredareashouldbeevaluatedbyaphysician. 27 TherearenoprospectivestudiesontheuseofheatlampsorotherheattherapiesinAOM practice.OnestudyutilizingheattherapiesincancertreatmentidentifiedAEsof“thermal lesions”fromthispractice.(13)Heatcanaffectskininavarietyofways,includingbiologicaland molecularchanges(14)althoughtheseeffectsappearminimalwhenappliedintermittentlyin clinicalpractice.Significantadverseeventsofheatlampsandotherheattherapiesismostlikely limitedtoburns,thesecondaryeffectsofburns(infection)andthepossibilityoffire.Seeabove informationaboutmoxibustionforcommonpracticestolimittheseAEs. Inoneretrospectivestudyofthefrequencyofburnsfromtherapeuticmodalitiesperformedin Korea,hotpacksweretwiceaslikelytocauseaburnaswastheapplicationofmoxibustion. Otherheattherapiesthatweresourcesofburnsinpatientcareincludedtheuseofelectric heatingpadsandradiantheat/heatlamps.(15) Safety Guidelines for Heat Therapies Other than Moxa Critical • Heatlampsshouldnotbeusedoninfants,children, incapacitatedpersons,orsleepingorunconsciouspersons. • Preventwater,moisture,liquidsormetalobjectsfromcoming incontactwiththelamp.DoNOTusethislampinwetormoist environments. • Donotuseifanypartofthelampiscracked.Donotallowany partofthelamptotouchaccessoryequipment. • Whenheatlampsareusedonpatientswhohaveareduced responsetoheat,theuseofheatmustbemonitoredatall times. Strongly • Donotuseheatlampsincloseproximitytocombustible Recommended materials(litter,paper,etc.)ortomaterialsadverselyaffected byheatordrying. • Takeacarefulpatienthistorytoidentifydiabetes,neuropathies orotherconditionsthatmightlimitapatient’sresponsetopain ortheabilitytosenseheat. • Donotuseoversensitiveskinorpersonshavingpoorblood circulation.Sufficienttemperaturesaregeneratedthatmay causeburns. • Heattherapiesmustbecloselymonitoredbypractitioners. • Thepractitionershouldmonitortheskintemperatureand amountofheatgeneratedbyaheatlampandnotrelysolelyon patientfeedbackaboutheatsensations. Recommended • Whenpatientinformationisunclear,requestanopinionfroma physicianbeforeusingaheatlamponthelimbsofapatient withdiabeticorotherneuropathies. 28 References 1.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages Press,Beijing;1987,pp.363-369. 2.ParkJE,LeeSS,LeeMS,ChoiSM,ErnstE.Adverseeventsofmoxibustion:asystematic review.ComplementTherMed.2010Oct;18(5):215-23.doi: 10.1016/j.ctim.2010.07.001.Epub2010Aug19. 3.XuS,WangL,CooperE,ZhangM,ManheimerE,BermanB,ShenX,LaoL.AdverseEventsof Acupuncture:ASystematicReviewofCaseReports.Evidence-BasedComplementary andAlternativeMedicineVolume2013http://dx.doi.org/10.1155/2013/581203. 4.YamashitaH,TsukayamaH,TannoY,NishijoK.Adverseeventsinacupuncture andmoxibustiontreatment:asix-yearsurveyatanationalclinicinJapan.JAltern ComplementMed.1999Jun;5(3):229-36. 5.LeeKW,HanSJ,KimDJ,LeeMj.Spinalepiduralabscessassociatedwithmoxibustion-related infectionofthefinger.JSpinalCordMed.2008;31(3):319-23. 6.MunJH,JeonJH,JungYJetal.Thefactorsassociatedwithcontactburnsfromtherapeutic modalities.AnnRehabilMed.2012Oct;36(5):688-95.doi:10.5535/arm.2012.36.5.688. Epub2012Oct31 7.WheelerJ,CoppockB,ChenC.Doestheburningofmoxa(Artemisiavulgaris)intraditional Chinesemedicineconstituteahealthhazard?AcupunctMed.2009Mar;27(1):16-20. 8.HatsukariI,HitosugiN,OhnoR,etal.Partialpurificationofcytotoxicsubstancesfrommoxa extract.AnticancerRes.2002Sep-Oct;22(5):2777-82. 9.SonCG.Safetyof4-weekindirect-moxibustiontherapyatCV4andCV8.JAcupunctMeridian Stud.2011Dec;4(4):262-5.doi:10.1016/j.jams.2011.09.018.Epub2011Oct19. 10.B.Zhao,G.Litscher,J.Li,L.Wang,Y.Cui,C.HuangandP.Liu,"EffectsofMoxa(Artemisia Vulgaris)SmokeInhalationonHeartRateandItsVariability,"ChineseMedicine,Vol.2 No.2,2011,pp.53-57.doi:10.4236/cm.2011.22010. 11.BardiaA,WilliamsonEE,BauerBA.Scarringmoxibustionandreligiousscarificationresulting inhepatitisCandhepatocellularcarcinoma.Lancet.2006May27;367(9524):1790. 12.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress, Seattle,WA.1981. 13.WehnerH,vonArdenneA;KaltofenS.Whole-bodyhyperthermiawithwater-filtered infraredradiation:technical-physicalaspectsandclinicalexperience.IntJHyperthermia; Volume:17,Issue:1,Pages:19-30 14.SchiekeSM,SchroederP,KrutmannJ.Cutaneouseffectsofinfraredradiation:fromclinical observationstomolecularresponsemechanisms.Photodermatology.Volume19,Issue 5,pages228–234,October2003 29 15.MunJH,JeonJH,JungYJetal.Thefactorsassociatedwithcontactburnsfromtherapeutic modalities.AnnRehabilMed.2012Oct;36(5):688-95.doi:10.5535/arm.2012.36.5.688. Epub2012Oct31 30 3. Cupping Safety/Adverse Events – A Review of the Literature CuppingisacommonlyusedtherapeuticprocedureusedbyAOMandotherhealthcare practitioners.Cuppingusesapartialvacuumthatcausesthetissuetotumefyandstretchinto thecup.Cuppingintentionallycreatestherapeuticpetechiaeandecchymosisthatappearin roundor“nummular”areas.(1) Therearethreetypesofcupping,eachwithdifferentsafetyprofiles:firecupping,suction cupping,andwetcupping(cuppingaftertheuseofalancetforbloodwithdrawal).Firecupping andsuctioncuppingarevariationsofdrycupping.Bothdryandwetcuppingareusedin traditionalEastAsianmedicine,thetraditionalmedicineofGulfArabs(hijamah),(2)in Europeancountries,andinearlyWesternmedicineanditslineageofearlyGreek,Romanand Egyptianmedicine.Cupsusedinthemodernsettingaremadeofglass,plastic,orsilicone. Cuppingisutilizedbypractitionerstotreatconditionsincludingacuteorchronicpain;mildto severeconditionssuchascolds,flu,andfever;respiratoryproblemssuchasasthma,bronchitis, andemphysema;functionalinternalorganproblems;musculoskeletalproblems;andinany caseofrecurringorpersistentfixedpain.(1,3)“Since1950…cuppingtherapyhasbeenapplied asaformalmodalityinhospitalsthroughoutChinaandelsewhereintheworld.”(4) Xueetal.(5)reportthatovera12-yearperiodmostAEsassociatedwithcuppingwereminor andwereprimarilykeloidscarring,burnsandbullae.Otherreviewssimilarlyreportnoserious AEsfromcupping.(1,3,6)However,thereareadverseevents,seriousadverseeventsand negligenterrorsreportedintheliteraturefromcuppingand,whilenotcommon,mostcanand mustbeavoided. Fire Cupping Burnsfromfirecuppingarereportedintheliterature;theyareanavoidablemedical error/adverseevent.(6-11)Inthisprocedure,aballofburningcottonoralitalcoholswabis brieflyplacedinsideaglasscuptoheattheairinside,whichthencreatesapartialvacuumasit cools.Glasscupsareused,asglassisimpervioustoheatatthelevelsusedforthisprocedure. Typically,cupsareleftonthepatient’sskinfor2-10minutes,butmaybeleftinplaceforupto 20minutes,andleaveatemporaryreddishmarkthatisaresultofcutaneouspetechiaeand ecchymosis.Unintentionalexpressionofbloodorfluidintocupsmayoccurasaresultoffire cuppingwhentheskinisnotintact,orfrompreviousneedling,localpimplesorotherlocalskin pathologies. Burnsmaybearesultofplacingtheflametooclosetothelipofthefirecupsothattheedge becomesveryhot,orfromdroppingtheburningmaterialintothefirecup,thenplacingthecup 31 ontheskinwiththehotmaterialinsidethecup.Whilethislatterprocedurehasbeenused traditionally,moderncuppingshouldlimitthisprocess. Suction Cupping Suctioncuppinginvolvestheuseofplasticorsiliconecupswithvalvesatthetopthatattachto handpumps;thepumpscreatesuctionbyremovingaquantityofairafterthecupshavebeen placedontheskin.Typicallycupsareonfor2-10minutes,butmaybeleftinplaceupto20 minutesandleaveatemporaryreddishmarkthatisaresultofcutaneouspetechiaeand ecchymosis.Unintentionalexpressionofbloodorfluidintocupsmayoccurasaresultof suctioncuppingwhentheskinisnotintact,orfrompreviousneedling,localpimplesorother localskinpathologies. Wet Cupping Inthisprocedure,theskinispuncturedwithalancetorsterileneedles,suchasthoseusedfor plumblossomtapping,beforethecupsareapplied.Wetcuppingmaybedonewitheither suctioncupsorfirecups.Thetechnique,whichdrawsoutbloodandOPIM,carriesobviousrisk ofexposuretoandtransferofbloodbornepathogens. Other Cupping Procedures Practitionersalsousecuppingtechniquesthatincludemovingorslidingcuppingduringwhich practitionersgentlymovethecupalongalubricatedsurfacearea,channel,oralongmuscle fibers;emptycupping,whichmeansthecupsareremovedaftersuctionwithoutdelay;or needlecupping,duringwhichthepractitionerappliestheacupunctureneedlefirst,thenapplies thecupsovertheneedles.Therisksofthefirsttwotechniquesarequitelimited.Inthelast technique,therisksaremorerelatedtotheneedlingthanthecupping.Cuppingmaycompress thetissue,causingacupunctureneedlestopenetratemoredeeplywithneedlecupping,or subcutaneoustissuesmaybepulledupwardwiththesameeffect,increasingtheriskof pneumothoraxorotherorganpunctureifdoneoverthethoracicregion.Ifneedlingcuppingis doneoverotherareasofthebody,theremayberisktothecentralorperipheralnervesor bloodvessels.Needlecuppingshouldbeappliedwithcautionandwithneedlesinsertedatan obliqueangle. Cupping Adverse Events Skin Reactions Somereactionstocuppingmaybepartofthetherapeuticprocessbutbeinterpretedbyother practitionersorobserversas“harms”(12)orevenchildabuse.(13,14)Theseincludeswelling, petechiae,ecchymosis,andpersistenthyperpigmentation.Typicallythesereactionsresolveina fewdaysto2weeks.(1)Researchhasnotestablishedstandardsfortheappropriatetimefor cupstobeleftinplaceortheamountofvacuumsuctionthatisideal;excessivecuppingtimeor 32 suctioncancreatebruisingandhyperpigmentationthatisuncomfortableandpersistsformuch longer. Fluidblisterscalledbullaearenotaninfrequentoutcomeofcupping.(14-17)Ifthesecontain bloodtheyarecalledhemorrhagicbullae,andarelesscommonandmaybemorelikelyin patientsonanticoagulantmedicationsandsupplementsthatmayactasbloodthinners.They canformcrustingscabsastheyheal,whichcantakeupto2weeks.(18)Theopeningoftheskin barrierovertimecreatesexposureandriskofinfection.Intheinadvertenteventofsuction bullae,patientsshouldbeinstructedonuseofantibiotictopicalointment,andonkeepingthe areacleanandcovered,ifnecessary,untilhealed. Otherunusualskinlesionsreportedinthecuppingliteraturearepanniculitisandkeloid scarring.Factitial(self-inflicted)panniculitis(fattylayerinflammation)canbeproducedby mechanical,physicalorchemicaltrauma.(19)Itpresentsasrednodules,inflammationwithin thecircularareawherecupswereapplied.Itistypicallyself-limitingandfadeslikeadeep bruisewithin6weeks,butcanbecomeinfectedandrequiresurgery.(16)Ifapatientdevelops redsubcutaneousnodules,avoidfurthercuppingandreferformedicalobservation. TwoarticlesintheliteratureestablishthatitispossibletoinduceKöebnerphenomenonin psoriasispatients.(20,21)Thesearticlesdescribetheappearanceofpsoriasislesionsfrom pressureortraumatothesurface.Historyorpresentationofpsoriasisinapatientmight cautionagainstaggressivecupping,orcuppingatall. Onecaseintheliteraturereportedthedevelopmentofakeloidscarattheupperbackfroma cuppingtreatmentforcough.(22)Thepatienthadnothadpreviouskeloidscarring,makingthis anunanticipatedadverseevent.Itisrecommendedtoproceedwithcaution,toavoidcupping orstrongcuppinginpatientswhoalreadyhavekeloidscars. Cardiovascular Cuppingisassociatedwithadverseeventsinvolvingthebloodandheart.Iron-deficiency anemia(IDA)inmeninKoreanotidentifiedfromotherknowncausesissuggested(butnot established)asrelatedtowetcupping.(23)Leeetal.(24)doreportonasinglecaseof excessivewetcuppingover6monthsinducingIDAwhereothercauseswereruledout.The patientrecoveredafterstoppingwetcuppingandsupplementingwithiron.Sohnetal.(25) reportonawomanwhoself-appliedwetcuppingover10years,andcreatedsevereiron deficiencyanemiaandanenlargedheart(cardiachypertrophy)thatregressedovertimeonce shestoppedwetcupping,andsupplementedwithprescriptionmedicineandiron.Someofher cardiacsymptomspersistedat3months. 33 Kimetal.(26)reportonacaseofrepeateddrycuppingcausinganemiabutoffernoevidence otherthanpersistinghyperpigmentation.(27)Theyalsoassertthattraditionalcuppingcauseda delayincarewhenthepatienthadalreadyconsultedconventionaldoctorsforbackpain. ArarecomplicationofacquiredhemophiliaAwascausedbycuppingina58-year-oldwoman. (28)Itpresentedasextensiveandcompressivebruisingwhichledtopendingcompartment syndromeofherleftthigh2daysaftercupping,resultinginhospitalization.Acquired hemophiliaAisveryrarebutcandevelopinassociationwithautoimmunedisease,allergicdrug reactions,malignancies,andpregnancywithhigherriskindepressionandanxiety.Forour purposestonote,thepatientwascuppedonthemedialaspectsofthethighandarm. Vasovagalsyncope,arareAEofcupping,(16)ismorelikelytooccurwithunderlyingconditions thatmayincreasetheriskforsyncope(diabetes,renaldisease,seizuredisorders,fastingorlow bloodsugar). Aninterestingcaseofstroke14hoursaftercuppingwasattributedtocuppingpointsinthe locationofapplication.Cupswereappliedtotheneckclosetoanartery.Apre-existing conditionofpartialarterialocclusionwasnotidentified.Theforceofcuppingwasthoughtto haveeitherelevatedbloodpressurecreatinghemorrhageorstroke(leastlikely),ortohave precipitatedanintimaltearoftheliningoftheartery,orhavecreatedsufficientlocalstressas todisturba“thincap”atanocclusionsite.(29)Considerationmustbegiventoapplyingcups overtheareasoftheneckthatareclosetoarteries. Infections Infectionhasbeenreportedasanadverseeventofcupping.Leeetal.(30)describeacaseof cervicalepiduralabscess(C1-C3)fromacupuncturewithcuppingthatresolvedwithoral antibiotictreatment.Jungetal.(31)reportacaseofherpessimplexfromacupunctureand cuppingwheretheherpeslesiondevelopedinacircularpatternthatmatchedthe circumferenceofthecups,andattheacupuncturepuncturesitesthathadbeenapplied.The patienthadnopersonalorfamilyhistoryofrecurrentcutaneousherpessimplexvirus(HSV). HSVcanbespreadbyabradedskin.Traditionalcuppingwasalsooneriskfactorforhigh prevalenceofHTLV-IinfectioninNortheastIran,alongwithbloodtransfusionand hospitalization.(32)Turlayetal.(33)describealumbarabscessfromscarificationwetcupping. Thesecasespointtothepossibilityoftransferofbloodbornepathogensfromcups.Honetal. (34)reportacaseofan11-year-oldgirlwhodevelopedStaphylococcusaureusinfectionfrom cupping,resultinginhospitalization.Thepatientwasbeingtreatedforchroniceczema. ColonizationofS.aureusiscommonlyseeninchroniceczemapatients. 34 Preventing Cupping Adverse Events Burns Burnsareassociatedwithfirecuppingonly.Generalsafepracticesforuseofanopenflame shouldbefollowed. Safety Guidelines to Avoid Fire Cupping Burns Critical • Takeacarefulpatienthistorytoidentifydiabetes,neuropathies,or otherconditionsthatmightlimitapatient’sresponsetopainorthe abilitytosenseheat.Assessthispatientcarefullywhenutilizingfire cupping. Strongly • Theburningmaterialmustbeplacedinthedeepestpartofthecup, Recommended notneartherim. • Removetheburningmaterialbeforeapplyingthecuptothepatient’s skin. • Neverretaintheburningmaterialinsidethecupwhenthecupis placedontotheskin. Infections Thesameproceduresarerecommendedasinpreparationforacupuncture:followSafety GuidelinesforEstablishingandMaintainingaCleanField,forHandSanitationandSkin Preparation.Wearpersonalprotectiveequipment(PPE)(glovesandprotectiveeyewear)when bloodorOPIMmaybepresent,ifperformingwetcupping,orcuppingafterneedling. Avoidcuppingoverlesions,rashes,injuriesorbreaksinskinbarrier.Colonizationofpathogens suchasStaphylococcusaureusisacommoncomplicationofatopicconditionssuchaseczema. (35)Whiletherearestudiesontheuseofcuppingforherpeszosterandotherskinlesions(6) practitionersshouldbespecificallytrainedincuppingforactiveskinlesionsbeforeapplying cups. SafetyGuidelinesforWetCuppingadvisesthatpractitionersmustwearglovesandprotective eyewearwhenengaginginwetcupping.Eachareatobewetcuppedshouldbethoroughly cleaned.Skincanbecleanedwith70%isopropylalcoholorsoapandwateroranothermethod, butmustbecleanedimmediatelybeforeperformingwetcupping.Theskinatthesiteshouldbe puncturedusingsterilelancets,pre-sterilizedtraditionalthree-edgedneedles,oraplum blossomtool,withanewlancetbeingusedforeachpunctureandthenimmediatelydiscarded inapropersharpscontainer.Applythecupsthathavebeenproperlydisinfectedforuseover nonintactskinandretainasneededforthedesiredeffect. 35 Whenremovingcupsthatcontainblood,allowthevacuumtobecompromisedslowlythen removethecup.ThepractitionershouldutilizePPEincludingglovesandeyeprotectionwhen bloodispresentinacupandthecupisbeingliftedtoberemoved.Someofthebloodcan aerosolizeorsplash,exposingthepractitioner’shands,wrists,eyesandothersurfaces.Clean thesiteofthepunctureswithanappropriateskincleanser.Discardtheextravasatedblood collectedbycottonswab,gauze,papertowelorclothinthebiohazardtrash.Thecupitselfmay bediscardedinthebiohazardtrashafterasingle-useor,ifintendedforreuse,mustbecleaned usingsoapandwaterandthensterilized.(1) Safety Guidelines to Prevent Cupping-Related Infections Critical • FollowStandardPrecautions. • FollowSafetyGuidelinesforEstablishingandMaintainingaClean Field. • FollowSafetyGuidelinesforHandSanitation. • Cuppingshouldbeappliedonclearskinonly.Donotapplycupsover anyactivelesions. • Whenperformingwetcupping,usePPEsuchasglovesandprotective eyewear. • Iflubricantsareused,decantaportionintoasecondarydisposable containerorontoasurfacesuchasapapertowelforuseonasingle patient.Dippingbackintotheoriginallubricantcontainerorretouchingthespoutofapumpcontainermustbeavoided. Strongly • Ifspecificallycuppingoveractiveherpeszosterlesions,dosoonly Recommended withadvancedtraininginhowtosafelytreatlesionswithcups. Standards for Reuse of Cupping Devices TheCDCestablisheslevelsofcriticalityformedicalinstrumentsintendedforreusetoprevent infection.(36).RecommendationsareestablishedbytheFDAforrequiredlevelsofdisinfection dependingoninstrumentcriticality.(37)Recentobservationalstudiesreportthatthe mechanicaloperationfromcuppingmayprovidesufficientpressureastocausetheleakingof fluidandbloodfromthesurface.(1)Accordingtotheauthors,unintentionalexpressionof bloodorfluidintocupsmayresultfromopenblemishesorpimples,andmayormaynotrelate toexcessivesuctionforce,skinfragility,orhydration.(1,38) Cuppingdevicesarecommonlyreusedonmultiplepatientsandifthecupisintendedtobe usedonnonintactskin,itwouldneedtobedisinfectedbasedontheCDClevelof“semi-critical instrumentsintendedforreuse.”(36)Cups,likeanysemi-criticalreusablemedicaldevice,must becleanedanddisinfectedusingahighleveldisinfection(HLD)solution.Anumberofchemicals clearedbytheFoodandDrugAdministration(FDA)aredependablehigh-leveldisinfectantsfor medicaldevices.(37)Itiscriticalthatthepractitionerchoosesthechemicaldisinfectantthatis 36 indicatedfortheintendeduseofthedevice,andfollowslabelinstructions,includinguseofPPE whiledisinfectingthedevices.SeePartVIformoreinformationaboutcleaningreusable medicaldevices. Becausetheskin,whichisanormalbarriertocrossinfection,hasbeenpiercedandisnolonger intact,cupsusedforwetcuppingareunquestionablysemi-criticalreusabledevices.(36)Insuch cases,therequirementistouseadisposablecup(anddisposeofitinthebiohazardtrash),or,if intendedforreuse,washthecupwithsoapandwater,andthendisinfectitusingahigh-level disinfectant,accordingtolabelinstructions.(1,36)Thesecupscanalternativelybesterilized usinganautoclave.Allsafetyproceduresandpackaginginstructionsmustbefollowedforcup disinfection.Duetotheircorrosivenature,somehigh-leveldisinfectionsolutionsareharmfulor fatalifswallowed.Donotgetineyes,onskin,oronclothing.Useventilation,proper containers,safetyglasses,andglovesasperlabelinstructions. Practitionersshouldcarefullyconsiderwhattypeofdisinfectingsolutiontoutilize.Many commercialproductshavesimilarproductnames.Thepractitionermustcarefullyreadabouta product’sinstructionsofuse,andhazardsofuseanddisposalwhenchoosingtheappropriate product.Formoreinformationconcerninghigh-leveldisinfectantsformedicaldevicessee http://www.fda.gov/medicaldevices/deviceregulationandguidance/reprocessingofreusablemed icaldevices/ucm437347.htm.(37) Cleaning and Disinfecting Cups Atthetimeofthewritingofthismanual,theliteratureisunclearaboutthelevelofdisinfection requiredforcups.Ifcuppingisperformedonintactskinonly,cupswouldbetreatedasnoncriticalreusablemedicaldevicesthatneedtobecleanedwithsoapandwater,andthen disinfectedinanappropriateintermediate-leveldisinfectantinaccordancewithlabel instructions.Cupsshouldberinsedanddriedwithcleantowels,andplacedinaclean,closed container.Whenevercupshavebeenorwillbeplacedovernonintactskin,theyneedtobe treatedassemi-criticalreusabledevices.Inthesecases,thecupsneedtobecleanedwithsoap andwatertoremovethelubricant(ifused)andbiologicalmaterialbeforedisinfectingwitha high-leveldisinfectantinaccordancewithlabelinstructions.Ifthecupswillbeusedon nonintactskin,theyshouldrinsedwithsterile,distilledorfilteredwater.Afterrinsing,dryand storeinamannerthatpreventsrecontamination.(36) Thecurrentcontroversyisabouthowoftentheskinbarrieriscompromisedwhencuppingover intactskin.ResearchersfromBethIsraelMedicalCenterhaveindicatedthatmicroscopic amountsofbloodandOPIMareregularlypresentincuppingprocedures.(1,38)However,few infectionsarereportedintheliteraturereviewsofcuppingAEs.(3,4,5,6)Cuppingoverintact skinisamodalityoftreatmentusedsafelyworldwidebylayandlicensedpractitioners.Inthe 2013reviewbyXuetal.,therewereonly10reportsofAEs:“Insixcases,therewasno 37 informationonpractitionertraining;intheotherfour,treatmentwasself-administered.”Of those10reports,nonewereofinfections.(5)Theonecasereportwedohaveofherpeticlesion infectionisbasedoncuppingoverzosterlesions,notintactskin.(31)Atthistime,thereareno reportsoflicensedacupuncturistsorotherpractitionersfromtheU.S.whousecupping,suchas massagetherapists,chiropractorsorphysicaltherapists,causinginfectionswithcuppingover intactskin.Morestudiesneedtobeperformedtodeterminehowfrequentlytheintactskinis disruptedincuppingproceduresnotassociatedwithbleedingtechniques. Furtherissuessurroundthesafetyofusinghigh-leveldisinfectingsolutionsintheclinical setting.(39-41)Manyarecausticandrequireventilationhoodsandothersafetyproceduresnot readilyavailabletoaprivatepractitioner.Afewsolutionsareapprovedforclinicaluseincluding thosethatcontainatleast7.5%hydrogenperoxidesolutionalongwithotherchemicals becausesuchsolutionsdonotrequirespecialventilation.(38)However,nonearewithoutrisk tothepractitionerorhealthcarepersonnelcompletingthedisinfectiontasks.Choosingthe appropriatechemicalsolutionandfollowinglabelinstructionsiscriticalnotonlytoprevent infection,butalsoforsafeusebythepractitioner. Theindividualpractitionermustgaugetheconditionofthepatient,whetherornottheareato becuppedhasnonintactskin,andtheextenttowhichtheirtechniqueofcuppingdisturbsthe intactnatureoftheskin’ssurface.Bloodbeingextruded,oropenblisterscreatedduring cuppingareobvioussignsthatthepractitioner’stechniquedisruptstheskinbarrier.The practitionermustkeepinmindthatvisualinspectionalonemaynotbeadequatetoassessthe degreethatskinhasbeendisruptedbycupping.Becausethepractitionercannotknowthatthe skinhasbecomedisrupteduntilafterithasbecomedisrupted,andtakingintoconsideration thepotentialrisktopatients,itistheeditor’sopinionthatisprudenttoconsiderhigh-level disinfectionofallcupsuntiladditionalstudiesarecompletedtodemonstratethedegreeto whichcuppingcompromisestheskinbarrier.Havingonemethodofdisinfectionincreasesthe practicalconsiderationsthatthepractitionerwillalwayshavepreparedandbeusingdevices thathavebeenproperlydisinfected. Safety Guidelines for Cup Disinfection Critical • Cleanallcupsofalllubricantsandbiologicalmaterialusingsoapand waterbeforedisinfecting. • DisinfectallcupsusinganappropriateFDA-clearedintermediateto high-leveldisinfectingsolutioninaccordancewithlabelinstructions. • UseappropriatePPEwhilecleaninganddisinfectingcups. Strongly • Disinfectallcupsusingahigh-leveldisinfectingsolutionfollowing Recommended packagedirectionsforsemi-criticaldevices. Recommended • Usedisposablecupsforwetcuppinganddisposeofusedwetcupsin thebiohazardtrash. 38 Extensive Bruising & Other Skin Lesions Whilepetechiaeandecchymosisareexpectedaftercupping,extensivebruisingcanresultfrom eitherapplyingthecupsfortoolongorwithtoostrongofavacuum.Extensivebruisingisarisk withpatientswhohavebleedingdisorderssuchashemophiliaorVonWillebrand’sdisease and/orcertainsupplements. Practitionersmusttakeathoroughhistory,includingbleedingdisordersandmedicationhistory, beforeapplyingcups.Cupusingcautioninpatientswithahistoryofbleedingdisorders,orwho arecurrentlytakingbloodthinningmedicationsorsomesupplements.Avoidwetcuppingfor patientswithahistoryofbleedingdisorders,bloodthinningmedications,orsomesupplements. Applycupswithcaution,conservatively,andcontinuallyobservetheprocesstogaugewhento removecups. Limittheretentiontimeofcupstothatofthephysicaltoleranceofthepatient,andthe intendedappearanceoftransitorytherapeuticpetechiaeandecchymosis.Observetheprocess ofcuppingtoavoidbullaeblisters. Takeapatienthistorytoestablishthepresenceorabsenceofkeloidsandpsoriasis.Explainthe riskofkeloidformationtoallpatientsandofKöebnerphenomenonforpatientswithpsoriasis. Safety Guidelines for Preventing Cupping Skin Lesions Critical Takeacarefulpatienthistoryto: • Screenpatientsforthepotentialforreactiveskinlesionssuchas keloidscarring(previouskeloids)andKöebnerphenomenon(history ofpsoriasis). • ScreenforbleedingdisordersincludinghemophiliaandVon Willebrand’sdisease. Strongly • Limittheretentiontimeofcupstothatofthephysicaltoleranceof Recommended thepatient,andtheintendedappearanceoftransitorytherapeutic petechiaeandecchymosis.Observetheprocessofcuppingtoavoid bullaeformation. Unintended Deep Penetration of the Needle Duringneedlecupping,whenapplyingcupsoverinsertedneedles,beawarethattheneedle maytravelbeyondasafedepthduetothecompressionofthetissue.Thisriskisonlyforneedle cupping.Allstandardneedleandcuppingguidelinesmustalsobefollowed. 39 Safety Guidelines for Needle Cupping Strongly • Applyoverneedlesthatareinsertedobliquelyinthethoracicregion Recommended toavoidpneumothorax. Safety Guidelines to Prevent Cupping Adverse Events Critical • Cuppingshouldnotbeapplied48hoursbeforeor24hoursafter chemotherapytreatment. Strongly • Ifapatientistakinganticoagulantandantiplatelettherapies,cupping Recommended shouldbeappliedwithanawarenessofpatientconditions;the cuppingprocessshouldbecarefullyobserved. • Limittheretentiontimeofcupstothatofthephysicaltoleranceof thepatient,andtheintendedappearanceoftransitorytherapeutic petechiaeandecchymosis. • Applicationofcuppingforchildrenshouldbedoneinthepresenceof aparentorassignedguardian. Recommended • Thereisariskthatcuppingpetechiaeandecchymosismaybe misinterpretedasillness,injuryorabuse.Itiscriticaltoexplainthe therapeuticintentionofcuppingaswellastheintendedtherapeutic petechiae/ecchymosis,andthetimelineoftheirresolution.Ahandout explainingcuppinginclinicalpracticemayprotectthepatientfrom thestressofmisinterpretation. References 1.NielsenA,KliglerB,KollBS.Safetyprotocolsforguasha(press-stroking)andbaguan (cupping).ComplementTherMed.2012;20(5)(October):340-344. 2.AbinaliHA.TraditionalmedicineamongGulfArabs:PartIIBlood-letting.HeartViews. 2004;58(20):74-85. 3.CaoH,HanM,LiXetal.ClinicalResearchEvidenceofCuppingTherapyinChina:ASystematic Literature.BMCComplementAlternMed.2010;10(1)(November16):70. 4.CaoH,LiX,LiuJ.Anupdatedreviewoftheefficacyofcuppingtherapy.PLoSOne. 2012;7(2):31793. 5.XuS,WangL,CooperEetal.Adverseeventsofacupuncture:asystematicreviewofcase reports.EvidBasedComplementAlternatMed.2013;2013:581203. 6.CaoH,ZhuC,LiuJ.Wetcuppingtherapyfortreatmentofherpeszoster:asystematicreview ofrandomizedcontrolledtrials.AlternTherHealthMed.2010;16(6)(Nov-Dec):48-54. 7.IblherN,StarkB.Cuppingtreatmentandassociatedburnrisk:aplasticsurgeon'sperspective. JBurnCareRes.2007;28(2)(April):355-358. 8.KoseAA,KarabagliY,CetinC.Anunusualcauseofburnsduetocupping:complicationofa folkmedicineremedy.Burns.2006;32(1)(February):126-127. 9.KulahciY,SeverC,SahinC,EvincR.Burncausedbycuppingtherapy.JBurnCareRes. 2011;32(2)(April):31. 40 10.SagiA,Ben-MeirP,BibiC.Burnhazardfromcupping--anancientuniversalmedicationstillin practice.BurnsInclThermInj.1988;14(4)(August):323-325. 11.SeicolHH.ConsequencesofCupping,totheEditor.NEJM.1997;336:1109-1110. 12.FrancoG,CalcaterraR,ValenzanoM,PadoveseV,FazioR,MorroneA.Cupping-relatedskin lesions.Skinmed.2012;10(5)(October):315-318. 13.ManberH,KanzlerM.ConsequencesofCupping.NEJM.1996;335:1281. 14.PengC-Z,HowC-K.Bullaesecondarytoprolongedcupping.AmJMedSci.2013;346(1) (July):65. 15.LinC-W,WangJT-J,ChoyC-S,TungH-H.Iatrogenicbullaefollowingcuppingtherapy.J AlternComplementMed.2009;15(11)(November):1243-1245. 16.MoonS-H,HanH-H,RhieJ-W.Factitiouspanniculitisinducedbycuppingtherapy.J CraniofacSurg.2011;22(6)(November):2412-2414. 17.TuncezF,BagciY,KurtipekGS,ErkekE.Suctionbullaeasacomplicationofprolonged cupping.ClinExpDermatol.2006;31(2)(March):300-301. 18.J,BelinchonI,BanulsJ,PastorN,BetllochI.[Skinlesionsfromtheapplicationofsuction cupsfortherapeuticpurposes].ActasDermosifiliogr.2006;97(3)(April):212-214. 19.LeeJ,AhnS,LeeS.Factitialpanniculitisinducedbycuppingandacupuncture.Cutis. 1995;55:217-218. 20.VenderR,VenderR.Paradoxical,cupping-inducedlocalizedpsoriasis:akoebner phenomenon.JCutanMedSurg.2014;18(0)(Dec1):1-3. 21.YuRX,HuiY,LiCR.Köebnerphenomenoninducedbycuppingtherapyinapsoriasispatient. DermatolOnlineJ.2013;19(6)(Jun15):18575. 22.BirolA,ErkekE,KurtipekGS,KocakM.Keloidsecondarytotherapeuticcupping:anunusual complication.JEurAcadDermatolVenereol.2005;19(4)(July):507. 23.YunGW,YangYJ,SongICetal.Aprospectiveevaluationofadultmenwithiron-deficiency anemiainKorea.InternMed.2011;50(13):1371-1375. 24.LeeHJ,ParkNH,YunHJ,KimS,JoDY.Cuppingtherapy-inducedirondeficiencyanemiaina healthyman.AmJMed.2008;121(8)(August):5-6. 25.SohnI-S,JinE-S,ChoJ-Metal.Bloodletting-inducedcardiomyopathy:reversiblecardiac hypertrophyinsevereanemiafromlong-termbloodlettingwithcupping.EurJ Echocardiogr.2008;9(5)(September):585-586. 26.KimKH,KimT-H,HwangboM,YangGY.Anaemiaandskinpigmentationafterexcessive cuppingtherapybyanunqualifiedtherapistinKorea:acasereport.AcupunctMed. 2012;30(3)(September):227-228. 27.NielsenA,KliglerB,MichalsenA,DobosG.Diddrycuppingcauseanaemia?AcupunctMed. 2013March13. 28.WengY-M,HsiaoC-T.AcquiredhemophiliaAassociatedwiththerapeuticcupping.AmJ EmergMed.2008;26(8)(October):970-971. 41 29.Blunt,StaviaBandLee,HeowPueh.Can“traditional“cuppingtreatmentcauseastroke? MedHypotheses.2010May;74(5):945-9.doi: http://dx.doi.org/10.1016/j.mehy.2009.11.037.Epub2009Dec23. 30.LeeJ-H,ChoJ-H,JoD-J.Cervicalepiduralabscessaftercuppingandacupuncture. ComplementTherMed.2012;20(4)(August):228-231. 31.JungY-J,KimJ-H,LeeH-Jetal.Aherpessimplexvirusinfectionsecondarytoacupuncture andcupping.AnnDermatol.2011;23(1)(February):67-69. 32.RafatpanahH,Hedayati-MoghaddamM,FathimoghadamFetal.HighprevalenceofHTLV-I infectioninMashhad,NortheastIran:Apopulation-basedseroepidemiologysurvey.J ClinVirol.2011;52(3)(November16):172-6. 33.TurlayMG,TurqutK,OguzlurkH.Unexpectedlumbarabscessduetoscarificationwet cupping:Acasereport.ComplementTherMed.2014;22(2)(Aug):645-7. 34.HonKL,LukD,LeongK,LeungA.CuppingtherapyMaybeHarmfulforEczema:aPubMed Search.CaseRepPediatr.2013;605829(Oct27). 35.HonKL,NipSY,CheungKL.Atragiccaseofatopiceczema:malnutritionandinfections despitemultivitaminsandsupplements.IranJAllergyAsthmaImmunol.2012;11(3) (September):267-270. 36.RutalaWA,WeberDJ,GuidelineforDisinfectionandSterilizationinHealthcareFacilities, 2008.CentersforDiseaseControlandPreventionHealthcareInfectionControlPractices AdvisoryCommittee(HICPAC). http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfReviewed December29,2009.AccessedJanuary18,2015. 37.FoodandDrugAdministration.Reprocessingofreusablemedicaldevices,FDA-cleared sterilantsandhighleveldisinfectantswithgeneralclaimsforprocessingreusable medicalanddentaldevices—March2009.Sept11,2014. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReu sableMedicalDevices/ucm133514.htm(AccessedJan18,2015). 38.NielsenA,KliglerB,KollBS.Addendum:SafetyprotocolsforGuasha(press-stroking)and Baguan(cupping).ComplementTherMed.2014;22(3):446-448. 39.RutalaWA,ClontzEP,WeberDJ,HoffmannKK.Disinfectionpracticesforendoscopesand othersemicriticalitems.Infect.ControlHosp.Epidemiol.1991;12:282-8. 40.PhillipsJ,HulkaB,HulkaJ,KeithD,KeithL.Laparoscopicprocedures:TheAmerican AssociationofGynecologicLaparoscopists'MembershipSurveyfor1975.J.Reprod. Med.1977;18:227-32. 41.MuscarellaLF.Currentinstrumentreprocessingpractices:Resultsofanationalsurvey. GastrointestinalNursing2001;24:253-60. 42 4. Electroacupuncture (EA) Safety/Adverse Events – A Review of the Literature Electroacupuncture(EA)isusedbymanyacupuncturistsasanadjunctivetherapyforconditions associatedwithqi,blood,orphlegmstagnation.Priortotheadventofmodernelectrical appliances,handmanipulationoftheneedleswasusedtostronglystimulateqiflow.EAisused toreplaceprolongedneedlemanipulationforconditionsinwhichthereisanaccumulation ofqi,suchasinchronicpainsyndromes,orincaseswheretheqiisdifficulttostimulate.(1) Thereareveryfewstudiesofthepotentialadverseeventsofelectroacupuncture(EA).One recentreviewoftheliteraturefrom1979-2010foundonly44incidencesofAEsreportedduring thattimeframeineitherEnglishorChinesedatabases.(2)WhileanumberoftheAEswere probablyassociatedwiththeacupuncture(faintness,hyperventilation)afewwereassociated withtheapplicationofanelectricalcurrent(electricalinjury,atrioventricularblock,dislocation ofthewristjointfrommusclespasmandothers).(2) Areportfromaonepractitionerconcludedthat“mostofthesafetyimplicationsrelatedtothe applicationofEAaretheoretical,andtherearefewreportsintheliteratureofseriousadverse eventsthatrelatetotheelectricalstimulusasopposedtothetraumaofneedling.”(3)Zhaoet al.(4)reportnoadverseeventsinuseofEAintheirreportof60patientsreceivingEAtherapy formusclespasticityafterbraininjury. TheremaybeincreasedrisksassociatedwiththeneedlingtechniquesneededforEA.A practitionermustbeawareofguidelinesforinsertiondepthwhenusingEA.Boththedepthand directionofinsertionoftheneedlesisoftenadjustedbypractitionersfortheapplicationofEA inordertoensurethattheneedlescansupporttheweightoftheelectricalleadsandclipsfor theperiodofstimulationwithoutfallingout.EAisoftenappliedfor20–30minutesandmay involvestrongmusclecontraction.Boththeuseofincreaseddepthofinsertionandtheneedto alterinsertionangleatcertainpointsrequirethepractitionertohaveanexcellentgraspofthe anatomyunderlyingthepointsinorderforsafeneedling. NeedletypeandsizeisalsoimportantwithEA.Certaintypesofmetalshouldbeavoidedforuse inEAsuchassilverneedles,whicharesofterthanstainlesssteelandmayelectrolyzeinthe bodyveryquicklyresultinginatoxicreaction.Additionalstudiesneedtobedonetoidentifythe besttypesofneedlestouseduringEA.Itmaybeadvisabletoavoidneedleswithaplastic handleduetodiminishedconduction;and,thereisatheoreticalconcernaboutverynarrow gaugeneedlesandpossiblebreakagefromelectricalconduction.Stainlesssteelneedlesare safetousewithelectricalstimulation. 43 Excessive Current ThecurrentusedfortherapeuticEArangesfromabout0.5to6mA.Inanotherwisehealthy subjectwithnoimplantedelectricaldevices,themedicalliteratureassociatedwiththeuseof nervestimulatingdevicessuggeststhatthislevelofcurrentshouldbesafe.(5,6) Higherlevelsofcurrentmaycausesignificantspasmsoflocalmuscles;skeletal,cardiacand smoothmusclefiberscanallbestimulatedthroughtheuseofelectricalcurrentsleadingto inadvertentmusclespasms.Thelevelofelectricalstimulationshouldremainjustbelowthe levelofpainasperceivedbythepatientandmusclecontractionshouldbeavoidedinmost applicationsofEA.WhilethereareapplicationsofEAthatinvolvemusclecontractionaspartof thetherapy(suchastreatmentforpalsy),suchtreatmentsneedtobecloselymonitored. Anatomical Considerations A2008studyofthesafetyofEAreported,“Whentheneedlesareplacedincloselyadjacent acupuncturepointsinalimb,thereislittleornodetectablespreadofthecurrentsalongthe limborintothechest.Bycontrast,whentheneedlesareplacedfarapart,theelectrical currentsspreadwidely.”(7)EAshouldbeavoidedinthefollowinglocationstoprevent theoreticalAEs: 1. Anteriortriangleoftheneck.Duetothelocationofthecarotidsinuswhichregulates bloodpressure,thelaryngealmusclesassociatedwithbreathing,andthevagusnerve (cranialnerve10),EAshouldnotbeutilizedinthisarea. 2. Posteriorcervicalarea.ThepresenceofthebrainstemmayprohibittheuseofEA. 3. Crossingthespine.EAmayinterferewithnormalnerveconduction. 4. Crossingtheheart.EAmayaffectthefunctionoftheelectricalsystemintheheartand thecontractionofthecardiacmuscle. 5. Inanypatientwithimplantedmedicaldevices:ICDs(implantablecardioverter defibrillator)andpacemakers. Adverseevents(orpotentiallyadverseevents)relatedtotheuseofEAhavebeenreported; thesehavemostlyrelatedtocardiaceffects(angina,cardiacarrest,interferencewithademand pacemaker).(7,8,9)Inonereport,however,theuseofEAinthelimbsinsomeonewitha pacemakerdidnotinterferewiththeactionofthecardiacpacemaker,andtheauthorsofthat studysuggestthatthisrestrictionbere-thought.“Theresultsofthiscasestudysuggest thatEAmightbeasafealternativeforpatientswithapacemaker....Everypatientshouldbe consideredwithcare,individually.”(10) AccordingtoLowandReed’stextbookonelectrotherapy,5mAdirectcurrent(DC)appliedto humantissuesinvivoresultsinchemicalchangesatthesitesofcontactwiththeelectrodes.A negativechargeatthecathoderesultsinanalkalineenvironmentandliquefactionofproteins. 44 Apositivechargeattheanoderesultsinanacidicenvironmentandcoagulationofproteins. (11)TheuseandfunctionofthetwopolesofEAfordifferentAOMapplicationsneedsfurther researchandelucidation. Preventing EA Adverse Events TherearenocommonadverseeventsassociatedwithEAreportedintheEnglishliterature. UncommonAEscanmostlybepreventedbypropertrainingandanawarenessof contraindicationsforthetherapy. Certaintypesofmetalshouldbeavoidedforuseinelectroacupuncturesuchassilverneedles, whicharesofterthanstainlesssteelandmayelectrolyzeinthebodyveryquicklyresultingina toxicreaction.Stainlesssteelneedlesaresafetousewithelectricalstimulation.(3) Safety Guidelines for Preventing EA Adverse Events Strongly • Electricalstimulationshouldnotbeappliedfromonesideofthechest Recommended acrosstotheothersideofthechest(fronttobackorsidetoside)inthe regionoftheheart.Acircuitshouldnotcrossthemidsagittallineofthe patient. Recommended • AvoidapplyingEAnearthebrainstem. • Avoidcrossingthespinewiththeelectricalstimulus. • Consultwiththeprimaryphysicianofanypatientwithahistoryofa seizuredisorderbeforeinstitutingEA. Injuries Due to Muscle Contraction Excessiveelectricalcurrentcancausesignificantmusclespasmswhichmaythencauselocal tissueorbonedamage.EAshouldneverbeemployedinsuchamannerastocausecontinuous, strongmusclespasms. Safety Guidelines for Preventing Excessive Muscle Contraction During EA Critical • EAshouldnotbeusedoninfants,children,incapacitated,sleepingor unconsciouspersons. • TurnuptheamperageoftheEAmachineslowlyandaskforconstant feedbackfromthepatientaboutsensationofpain;electricalstimulation shouldbeturnedoffbeforeneedlesareremovedfromthebody. • Thelevelofstimulusshouldneverapproachthesensationofpain. Strongly • ApplyEAinsuchamannerastoavoidmusclecontractionexceptinthose Recommended caseswheremusclestimulationistheexpectedoutcome. 45 Electrical Injury Guidelinesforuseofelectricalsafetymustbefollowed.(See https://www.osha.gov/dte/grant_materials/fy09/sh-18794-09/electrical_safety_manual.pdf foranoverviewofelectricalsafety) Safety Guidelines for Preventing Electrical Injury During EA Critical • Preventwater,moisture,liquidsormetalobjectsfromcomingin contactwiththepatientortreatmenttable.DoNOTuseEAinwetor moistenvironments. • DonotuseifanypartoftheEAmachineiscrackedorotherwise damaged. • Donotuseifthewiresorleadsarenotingoodcondition. Interference with a Cardiac Pacemaker Electricalstimulationcaninterferewiththefunctioningofpacemakers.Patienthistoriesmust bespecificforrulingoutthatyourpatienthasapacemaker. Safety Guidelines for Preventing Interference with a Cardiac Pacemaker During EA Critical AvoiduseofEAonthetrunkofanyonewithanimplantedcardiacdevice, includingapacemaker. Strongly EAshouldnotbeusedonanypartofthebodyofpatientswith Recommended pacemakersorotherelectronicimplants. References 1.AudetteJF,RyanAH.Theroleofacupunctureinpainmanagement.PhysMedRehabilClinN Am;15(2004)749–77 2.ZhengW,ZhangJ,ShangH.Electro-Acupuncture-Relatedadverseevents(AE):ASystematic Review.MedicalAcupuncture.June2012,24(2):77-81.doi:10.1089/acu.2011.0858. 3.CummingsM.Safetyaspectsofelectroacupuncture.AcupunctureinMedicine2011Jun29(2): 83-529(2)83-5.2011 4.ZhaoW,WangC,LiZetal.EfficacyandSafetyofTranscutaneousElectricalAcupoint StimulationtoTreatMuscleSpasticityfollowingBrainInjury:ADouble–Blinded, Multicenter,RCT.PLoSOne.2015Feb2;10(2):e0116976.doi: 10.1371/journal.pone.0116976. 5.ElectricalSafetyTestingReferenceGuide.QuadTech,Inc.4thEdition,May2002,P/N 030120/A4http://www.psma.com/ul_files/forums/safety/estguide2.pdfAccessed December2012 6.HadzicA,VlokaJ,HadzicN,ThysDM,SantosAC.Nervestimulatorsusedforperipheralnerve blocksvaryintheirelectricalcharacteristics.Anesthesiology2003;98-969-74 46 7.ThompsonJW,CummingsM.Investigatingthesafetyofelectroacupuncturewitha Picoscope.AcupunctMed.2008Sep;26(3):133-9. 8.LauEW,BirnieDH,LemeryR,etal.AcupuncturetriggeringinappropriateICDshocks. Europace2005;7:85–6. 9.WhiteA.Acumulativereviewoftherangeandincidenceofsignificantadverseevents associatedwithacupuncture.AcupunctMed2004;22:122–133. http://aim.bmj.com/content/22/3/122.full.pdf 10.VasilakosDG,FyntanidouBP.Electroacupunctureonapatientwithpacemaker:acase report.AcupunctMed.2011Jun;29(2):152-3.doi:10.1136/aim.2010.003863.Epub2011 Mar 11.LowJ,ReedA.ElectrotherapyExplained:PrinciplesandPractice.Oxford:ButterworthHeinemann1991. 47 5. Therapeutic Blood Withdrawal Safety/Adverse Events – A Review of the Literature Therapeuticbloodwithdrawalisreferredtointheliteratureas“bloodletting”(MeSHterm: “Punctureofaveintodrawbloodfortherapeuticpurpose”),“pricking,”“bleeding,”orthe“use ofthethree-edgeneedle.”Forthepurposesofthisreview,wewillusetheterm“bleeding”to coverallvariationsoftherapeuticbloodwithdrawal. Bleedingisanoriginalformofmedicinefoundineveryearlyculture,includingearlyWestern medicine.(1)Thereisevidence,inchronologicaliterationsoftheNeiJingSuWen,that acupunctureitselfevolvedfrombloodletting.(2)InAOM,bleedingisdoneremovingonlydrops ofblooduntilitsqualityandcolorlightens.Itispossiblethatevenminorbleedingor hematomasatanacupunctureneedlesitemightbeconsideredpartofthetherapy.(3) Thebleedingofspecificpointsisanacupuncturetherapythatcontinuestobeusedtotreat,for instance,fevers,pain,oritching.(4) Thereisincreasinginterest,includingarticlesandstudies,onacupuncturetherapybloodletting. APubMedsearchon“acupuncturebloodletting”had97results,manyintheChineseliterature withsomeinEnglish. (http://www.ncbi.nlm.nih.gov/pubmed/?term=acupuncture+bloodletting).Bloodlettingis studiedasastand-alonetherapyorpairedwithacupuncture,cupping,guasha,moxibustionor inmultiplecombinationsoftherapies.AreviewofMedlineandCochranedatabaseswiththe terms"bloodlettingpuncture"and“needlepricking”yieldedonlylimitedcasestudiesand studiesinChinese,manyofwhichcombinebleedingtherapywithEAandacupunctureor cupping.NoAEswerereportedinanyofthestudiesavailableinEnglish. TherearenooverviewsofsafetyoradverseeventsinEnglishregardingbleedingtherapies.But intheirsystematicreviewonadverseeventsofauriculartherapy,Tanetal.(5)reportonminor infectionsassociatedwithauricularbloodletting.Theliteraturedoesestablishthattheuseof lancetsfordrawingbloodfromtheheelsofinfantsforlabtestingcarriesariskofinfection, thoughrare.(6)Asystematicreviewofwetcuppingforherpeszosterreportednoadverse eventsinanyofthetrials.(7)However,therearecasereportsofinfectionrelatedtowet cupping(seecuppingsection). Areviewoftheliteratureregardingtheuseoflancetsforcapillarybloodcollectionwassimilarly limited.Studiesfocusedonlimitingpainandproducingenoughbloodforpropertesting,noton anyadverseevents.(8)OnereportoftransmissionofHBVfromamulti-uselancingdevice pointsouttheneedforusingsingle-useonlydevicesforbleedingtechniques.Thisstudy identifiedthatanidenticalHBVviralstrainwaspresentforpatientsusingamulti-patient 48 lancingdevice,demonstratingthatmultiplepatientswerecrosscontaminatedwithHBVwhen lancetsforbloodlettingwerereused.(9) Onlypre-sterilizedsingle-usedisposablelancets,ratherthandevicesdesignedforhomeor officebloodsugarmonitoring,shouldbeusedinacupuncturepractice.Nopartofanylancing deviceshouldbereusedonotherpatientsorreusedatmultiplesitesonasinglepatient.Since blooddropletsmaycollectwithinthefingerstickorlancingdevice,eachnewpuncturepresents ariskforcrossinfection.Lancetscannotbeusedformultiplepatientsevenwhentheyare changedforeachnewpuncture. AccordingtotheCDC,“Fingerstickdevices,alsocalledlancingdevices,shouldneverbeshared, evenwithclosefamilyandfriends.Thisguidanceincludesboththelancet(i.e.,thesharp instrumentthatactuallypuncturestheskin)andthepen-likedevicethathousesthelancet. Neithershouldbeusedformorethanoneperson.” http://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html LancingDevice: Oncethelancethasbeenused,discarditinasharpscontainerimmediately.Single-usespring loadedlancetscanbeusedanddiscardedbuttheyaremoredifficulttocontrolintermsof specificpointlocationanddepth. Preventing Acupuncture Bleeding Therapy Adverse Effects Aswithacupunctureneedling,bleedingcarriesariskofinfection,localpain,bleeding,and bruising;safetyguidelinesforpreventingtheseadverseeventsarelistedintheprevious acupuncturesection.Thisincludesscreeningpatientsformedicationsorsupplementsthatmay thintheblood,suchasanticoagulantandantiplatelettherapiesandpainmedicationssuchas NSAIDS,aswellassomesupplements. Becausethelancetsbreaktheskinsurface,bloodandOPIMarepresentonthelancetsandmay beasourceofneedlestickinjuries.Practitionersmusttakecaretolimittheriskofneedlestick injuries.Retractablesingle-uselancetsmayallowbleedingtechniquestobepracticedwith 49 reducedrisktothepractitioner.Retractabledevicesneedtobenewforeachnewpatientto preventcrosscontaminationwithbloodbornepathogens. Safety Guidelines for Acupuncture Bleeding Therapy Critical • FollowSafetyGuidelinesforHandSanitation. • FollowSafetyGuidelinesforSkinPreparation. • Practitionersmusttakeathoroughhistoryincludingbleedingdisorders, medication,andsupplementhistorybeforeusingbleedingtechniques. • Personalprotectiveequipment(PPE)isrequired.Wearglovesatall timesasbloodandOPIMwillbepresent. • Inspectareatobetreatedforevidenceofinflammation,lesion, infection,orabreakintheskinbarrier.Donotbleedintheseareas. • Lancingdevicesmustbelimitedinusetoasinglepatient. • Lancetscannotbereusedafterasingleinsertion;notonanothersite. • Lancetsshouldbeusedonlyonceandthendiscardedinasharps container. Recommended • Utilizeeyeprotection,suchasgoggles,whenperformingbleeding techniques. • Utilizelancetsengineeredtoretractafterusetosignificantlyreducethe riskofneedlestickinjuries. References 1.HallerJS.AmericanMedicineinTransition1840-1910.Urbana:UniversityofIllinoisPress; 1981. 2.EplerDCJr.BloodlettinginearlyChinesemedicineanditsrelationtotheoriginof acupuncture.BulletinoftheHistoryofMedicine.1980;54(3)(Fall):337-67. 3.RammeB.[Minorhemorrhagesandpainatthepuncturesitearepartofthetherapy.Medical acupuncturehasnosevereadverseeffects!].MMWFortschrMed.2009;151(42)(Oct 15):6. 4.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages Press,Beijing;1987. 5.TanJ-Y,MolassiotisA,WangT,SuenL.AdvereseEventsofAuricularTherapy:ASystematic Review.EvidBasedComplementAlternatMed.2014;2014:506758. 6.OnesimoR,FiorettiM,PiliS,MonacoS,RomagnoliC,FundaroC.Isheelprickassafeaswe think?BMJCaseRep.2011Oct16:pii:bcr0820114677. 7.CaoH,ZhuC,LiuJ.Wetcuppingtherapyfortreatmentofherpeszoster:asystematicreview ofrandomizedcontrolledtrials.AlternTherHealthMed.2010;16(6):48-54. 8.WarunekD,StankovicAK.Evaluationoflancetsforpainperceptionandcapillaryblood volumeforglucosemonitoring.ClinLabSci.2008Fall;21(4):215-8. 50 9.LaniniS,GarbugliaA,PuroVetal.HospitalclusterofHBVinfection:molecularevidenceof patient-to-patienttransmissionthroughlancingdevice.PLoSOne.2012;7(3):e33122. doi:10.1371/journal.pone.0033122.Epub2012Mar6. 51 6. Gua Sha Safety/Adverse Events – A Review of the Literature GuashaisatraditionalEastAsianhealingtechniquedefinedasthe“closely-timed unidirectionalpress-strokingofthebodysurfacewithasmooth-edgedinstrumentto intentionallyraisetransitorytherapeuticpetechiaeandecchymosis(sha)representing extravasatedbloodinthesubcutis.”(1,2)Thepetechiaeandecchymosisresolvein2-4days. Guashaisusedinthetreatmentofpain,painonpalpation,andaccompanied“blanchingthatis slowtofade”indicatingshainthetissue.Guashatreatsbothacuteandchronicpain,acute respiratoryinfection,influenza,andfever,aswellasinternalorgandiseaseswherethe identifiedferrohememetabolismcanreduceinflammationandofferimmuneprotection.(3). TraditionalguashatoolshaveincludedChinesesoupspoons,edge-worncoins,variousbone devices,piecesofhonedjade,variousstainlesssteeldevices,orsimple,round,smooth-edged metalcaps.Thelatterisrecommendedasasingle-usedisposableinstrumentoronethatcanbe easilycleanedanddecontaminated.(1).Lubricantssuchasoil,balms,orwaterareappliedto theskinpriortoguasha.Guashaisthenappliedincloselytimedpressstrokesuntilpetechiae andecchymosisappear.Pressstrokingisthencontinuedatthenextstrokelinesequentially untiltheentireregionofinterestiscomplete.(1) Similartechniquesareusedbyotherhealthcarepractitionersandareidentifiedas“instrument assistedsofttissuetechniques.”Risksassociatedwithsuchtechniqueswouldbecomparableto thoseofguasha. RecentarticlessearchingtheMedlineandChineselanguagedatabasesforguashaAEfindno reportsoftransferofbloodbornepathogens,butciteexposuretobloodbornepathogensasa potentialrisk.(3)Theprimaryreportedriskwithguashaisthemistakingofthepetechiaefor signsofdisease,injury,orabusebyotherpractitioners.(3)Therefore,communicationbecomes asafetyissue,andprecautionsarerecommendedtoinformpatientsduringandafterguasha. Guashahasbeenshowntobeeffectiveinrandomizedtrialsforneckpain,(4)neckandback pain,(5)andbreastengorgement/mastitis.(6)NoseriousAEswerereportedinthesetrials.Gua shahasbeenshowntoincreasesurfacemicroperfusion(2)andupregulatehemeoxygenase-1 (HO-1)throughwhatiscalledferrohememetabolism.(7)Asthebloodcellsthathavebeen extravasatedareabsorbed,themetabolizingofferrohemeupregulatesgeneticexpressionof HO-1,creatingananti-inflammatoryandimmuneprotectiveeffect.(8) 52 Preventing Gua Sha Adverse Events Therearenocommonadverseeventsreportedforguasha.(9,10)Generalguidelinesto preventriskofexposuretobloodbornepathogensshouldbefollowed. Guashaiscontraindicatedoverrashorbrokenskin,swelling,inflammation,burn,orsunburn. Guashaisindicatedforinflammationandtissueinjury,butnotdirectlyatthesiteofactive inflammationorinjurytotheskinorunderlyingtissue.Guashaisnotcontraindicatedfor patientswithastableINRwhoaretakinganticoagulantmedication.Theuseofguashafor thosecurrentlytakinganti-coagulantmedication,NSAIDs,VitaminE,orfishoilsorforthose whohavebleedingdisordersshouldbelimitedtothosepractitionerswiththenecessary backgroundtoevaluatethesubcutaneousbleedingandtissueresponse. Becausetheintendedtherapeuticgoalofchemotherapyforcancerisapoptosis,andbecause guasha’supregulationofHO-1isanti-apoptotic,(8)itisrecommendedtoavoidapplyinggua sha(orcupping)for48hoursbeforeand24hoursafterchemotherapy. Safety Guidelines for Gua Sha Critical • FollowStandardPrecautions. • FollowSafetyGuidelinesforEstablishingandMaintainingaClean Field. • FollowSafetyGuidelinesforHandSanitation. • Takeacarefulpatienthistorytoidentifyifthepatientistaking medicationsthatthintheblood,suchasanticoagulantand antiplatelettherapies,painmedicationssuchasNSAIDSand supplementssuchasvitaminEandfishoils.Guashaisnot contraindicatedbutshouldbeappliedwithawarenessofthepatient’s condition. • Guashashouldnotbeapplied48hoursbeforeor24hoursafter chemotherapytreatment. • Whenreusingguashatools,selectonlytoolsthataredisposableor thathavebeenproperlydisinfected. • Iflubricantsareused,decantaportionintoasecondarydisposable containerorontoasurfacesuchasapapertowelforuseonasingle patient.Dippingbackintotheoriginallubricantcontainerorretouchingthespoutofapumpcontainermustbeavoided. • Guashashouldbeappliedonclearskinonly.Donotapplyguasha overanyactiverash,lesion,inflammation,infection,orbreakinthe skinbarrier. • Donotguashaoverswellingorrecenttrauma,includingoverburnsor sunburns. Strongly • Anyapplicationofguashaforchildrenshouldbedoneinthepresence Recommended ofaparentorassignedguardian. 53 Recommended • Explainthetherapeuticintentionofguashaaswellasthetimelinefor theresolutionofintendedtherapeuticpetechiaewithahandouton guasha. Disinfection of Gua Sha Devices Atthetimeofthewritingofthismanual,theliteratureisunclearaboutthelevelofdisinfection requiredforguashadevices.Whenusedonintactskinonly,guashadeviceswouldqualifyas non-criticalreusablemedicaldevices.TheCDCdefinitionsofnon-criticaldevicescanbefound inGuidelinesforDisinfectionandSterilizationinHealthcareFacilities.(11)Asnon-critical devices,reusableguashaspoonsandotherdeviceswouldbecleanedoflubricantsand biologicalmaterialwithsoapandwater,andthendisinfectedinanappropriateintermediateleveldisinfectant,inaccordancewiththelabelinstruction.Theyshouldberinsedanddriedwith cleantowels,andplacedinaclean,closedcontainer.Wheneverguashahasbeenorwillbe usedovernonintactskin,thetoolsneedtobetreatedassemi-criticalreusabledevices.Inthese cases,theguashatoolsneedtobecleanedandscrubbedwithsoapandwatertoremovethe lubricant(ifused)andbiologicalmaterialbeforedisinfectingwithahigh-leveldisinfectantin accordancewiththelabelinstruction.Ifthetoolswillbeusedonnonintactskin,theyshouldbe rinsedwithsterile,distilled,orfilteredwater.Afterrinsing,dryandstoreinamannerthat preventsrecontamination.(11)PractitionersmuststrictlyfollowFDAandmanufacturer guidelinesfortheuseofanyhigh-levelchemicaldisinfectant.(12)Iftheguashadevicesare heat-stable,terminalprocessingofsterilizationinanautoclavemaybeused.Single-use, disposableguashatoolsmayalsobeconsidered. Thereisacurrentcontroversyregardinghowoftentheskinbarrieriscompromisedduringgua sha.ResearchersfromBethIsraelMedicalCenterhaveindicatedthattheintentionalor unintentionalexpressionofbloodorfluidontoguashadevicesdemonstratesthepotential exposureto,andriskoftransferof,bloodbornepathogensand/orOPIM.(1)However,no infectionsarereportedintheliteraturereviewsofguashaAEs.(9,10)Guasha,likecupping,isa modalityoftreatmentusedworldwidebylayandlicensedprofessionals.Similartoolsareused inthemassagetherapy,chiropractic,andphysicaltherapyprofessions,withnoadverseevent reports.Morestudiesareneededtodeterminehowfrequentlytheintactskinisdisruptedin guasha. Furtherissuessurroundthesafetyofusinghigh-leveldisinfectingsolutionsintheclinical setting.(12-14)Manyarecaustic,andrequireventilationhoodsandothersafetyprocedures notreadilyavailabletoaprivatepractitioner.Afewsolutionsareapprovedforclinicaluse includingthosethatcontainatleast7.5%hydrogenperoxidesolutionalongwithother chemicals,becausesuchsolutionsdonotrequirespecialventilation.(3)However,noneare withoutrisktothepractitionerorhealthcarepersonnelcompletingthedisinfectiontasks. 54 Choosingtheappropriatechemicalsolutionandfollowinglabelinstructionsiscriticalnotonly topreventinfection,butalsoforsafeusebythepractitioner. Eachindividualpractitionermustgaugetheconditionofthepatientandtheextenttowhich theirtechniqueofguashadisturbstheintactnatureoftheskin’ssurface.Bloodbeingextruded duringguashaisanobvioussignthatthepractitioner’stechniquedisruptstheskinbarrier.The practitionermustkeepinmindthatvisualinspectionalonemaynotbeadequatetoassessthe degreethatskinhasbeendisruptedbyguasha.Becausethepractitionercannotknowthatthe skinhasbecomedisrupteduntilafterithasbecomedisrupted,andtakingintoconsideration thepotentialrisktopatients,itistheeditor’sopinionthatisprudenttoconsiderhigh-level disinfectionofallguashatoolsuntiladditionalstudiesarecompletedtodemonstratethe extenttowhichguashacompromisestheskinbarrier.Havingonemethodofdisinfection increasesthepracticalconsiderationsthatthepractitionerwillalwayshavepreparedandbe usingdevicesthathavebeenproperlydisinfected.Single-usedisposabletoolsmayalsobe considered. Safety Guidelines for Disinfection of Gua Sha Tools Critical • Cleanalltoolsofalllubricantsandbiologicalmaterialusingsoapand waterbeforedisinfecting. • DisinfectalltoolsusinganappropriateFDA-clearedintermediate-to high-leveldisinfectingsolution,inaccordancewithlabelinstructions. • UseappropriatePPEwhilecleaninganddisinfectingguashatools. Strongly • DisinfectalltoolsusinganFDA-clearedhigh-leveldisinfectingsolution Recommended forsemi-criticaldevices,inaccordancewithlabelinstructions. References 1.NielsenA,KliglerB,KollBS.SafetyprotocolsforGuasha(press-stroking)andBaguan (cupping).ComplementTherMed.2012;20(5)(October):340-344. 2.NielsenA,KnoblauchNTM,DobosGJ,MichalsenA,KaptchukTJ.Theeffectof‘Guasha’ treatmentonthemicrocirculationofsurfacetissue:apilotstudyinhealthysubjects. Explore(NY).2007;3:456-466. 3.NielsenA,KliglerB,KollBS.Addendum:SafetyprotocolsforGuasha(press-stroking)and Baguan(cupping).ComplementTherMed.2014;22(3):446-448 4.BraunM,SchwickertM,NielsenA,etal.EffectivenessofTraditionalChinese“GuaSha” TherapyinPatientswithChronicNeckPain;aRandomizedControlledTrial.PainMed. 2011;12(3)(January28):362-9. 5.LaucheR,WubbelingK,LudtkeRetal.Randomizedcontrolledpilotstudy:Painintensityand pressurepainthresholdsinpatientswithneckandlowbackpainbeforeandafter traditionalEastAsian‘Guasha’therapy.AmJChinMed.2012;40(5):905-917. 55 6.ChiuJ-Y,GauM-L,KuoS-Y,ChangY-H,KuoS-C,TuH-C.EffectsofGua-Shatherapyonbreast engorgement:arandomizedcontrolledtrial.JNursRes.2010;18(1)(March):1-10. 7.KwongKK,KloetzerL,WongKKetal.Bioluminescenceimagingofhemeoxygenase-1 upregulationintheGuaShaprocedure.JVisExp.2009Aug28;(30).Pii:1385,doi: 10.3791/1385. 8.XiaZ,ZhongW,MeyrowitzJ,ZhangZ.TheroleofHemeOxygenase-1inTCell-Mediated Immunity:TheAllEncompassingEnzyme.CurrPharmDesing.2008;14:454-464. 9.LeeMS,ChoiTY,KimJI,andChoiSM.UsingGuashatotreatmusculoskeletalpain:a systematicreviewofcontrolledclinicaltrials.ChinMed.2010Jan29;5:5.Doi: 10.1186/1749-8546-5-5 10.NielsenA.GuaSha,aTraditionalTechniqueforModernPractice.2ndedition.Edinburgh: ChurchillLivingstone;2012:158pgs. 11.RutalaWA,WeberDJ,GuidelineforDisinfectionandSterilizationinHealthcareFacilities, 2008.CentersforDiseaseControlandPreventionHealthcareInfectionControlPractices AdvisoryCommittee(HICPAC). http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfReviewed December29,2009.AccessedJanuary18,2015. 12.U.S.FoodandDrugAdministrationReprocessingofreusablemedicaldevices,FDA-cleared sterilantsandhighleveldisinfectantswithgeneralclaimsforprocessingreusable medicalanddentaldevices—March2009. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReu sableMedicalDevices/ucm133514.htm.UpdatedSeptember11,2014.AccessedJan18, 2015. 13.PhillipsJ,HulkaB,HulkaJ,KeithD,KeithL.Laparoscopicprocedures:TheAmerican AssociationofGynecologicLaparoscopists’MembershipSurveyfor1975.J.Reprod. Med.1977;18:227-32. 14.MuscarellaLF.Currentinstrumentreprocessingpractices:Resultsofanationalsurvey. GastrointestinalNursing2001;24:253-60. 56 7. Plum Blossom Needling Safety/Adverse Events – A Review of the Literature Plumblossomneedlesareusedforcutaneousacupuncturetreatments.Thesedeviceshavea numberofneedleprojectionscarriedwithinasinglehammer-likedevicewhichstriketheskinin amuchbroaderareathandosinglefiliformacupunctureneedles.Duetotheshapeofthesharp projectionsinthedevice,theinstrumentisoftenreferredtoasa“seven-star”hammer.In general,thesedevicesdonotpuncturesubcutaneoustissuebutratherstimulatethesuperficial orcutaneousacupuncturechannels.(1) Therearecurrently40studyarticlesonplumblossomtherapyinPubMed,almostallinChinese. AEsarenotreported.Thereisonetextonplumblossomtherapy(2)andamentioninthe O’ConnorandBenskytext.(1)Averyfewstudies,mostlyinChinese,reportedinformation aboutadverseeventsandinallcases,noAEswereidentified.(3,4,5) Usingplumblossom/sevenstarneedlingfortreatmentofavarietyofpainsyndromesincluding neuropathiescanbefoundinthemedicaldatabases.Butasmostofthesearticlesarewrittenin Chinese,theireffectonU.S.practicesisquitelimited.(6-9) Preventing Plum Blossom Needling Adverse Events WhilenoAEsassociatedwithplumblossom/sevenstarhammertreatmentsarereportedinthe literature,theuseofthisdeviceisnotwithoutrisk.Becausetheindividualneedle-like projectionsmaybreaktheskinsurfaceandareusedoverabroadareaofskinratherthana singlediscretepoint,transientpathogenscanbemovedfromoneareatoanother.Also,while bleedingisgenerallytobeavoided,bloodandOPIMmaybebroughttothesurfaceand releasedintotheair. Safety Guidelines for Plum Blossom (Seven Star) Therapy Critical • FollowSafetyGuidelinesforEstablishingandMaintainingaClean Field. • FollowSafetyGuidelinesforSkinPreparation. • FollowSafetyGuidelinesforHandSanitation. • Theareatobetreatedwithplumblossommustbecleanandfree ofanyskinlesionsortraumaticinjury.(9) • Personalprotectiveequipment(PPE)isrequired;wearglovesatall timesasbloodandOPIMwillbepresent. • Useonlysingle-usesterileplumblossom/sevenstarneedlesor deviceswithsingle-useremovableheads. • Theheadoftheplumblossomdevicemustbesterile.Donottouch thetipsoftheneedlesatthedevicehead. • Discardusedplumblossomneedlesinasharpscontainer 57 • Strongly Recommended • • Recommended • immediatelyafteruse.Toremoveareplaceablehead,use hemostatsortweezers.Ifasingle-usedeviceisused,discardthe entiredeviceinthesharpscontainer. Ifareusablehandleisused,itmustbesterilizedbeforethenext single-useremovable“head”isapplied. Avoidraisingthehandholdingthehammertoohigh,ortappingtoo forcefullytopreventpuncturingtheskin. Avoid“flinging”thehammeraroundtopreventparticulatesprayof bloodorOPIM. Practitionersshouldconsiderutilizingeyeprotectionwhileusing theplumblossomdevice. References 1.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress, Seattle,WA.1981,p.417. 2.KuangAnMenHospital.PlumBlossom'NeedleTherapy.HongKong:Medicine&Health Publishing;1978. 3.WuL,ZhangGL,YangYX.[ClinicalstudyonelectricalPlumBlossomneedlefortreatmentof amblyopiainchildren].ZhongguoZhongXiYiJieHeZaZhi.2011Mar;31(3):342-5. 4.YangJX,XiangKW,ZhangYX.[Treatmentofherpeszosterwithcottonsheetmoxibustion: multicentralrandomizedcontrolledtrial].ZhongguoZhenJiu.2012May;32(5):417-21. 5.ZhongJ,LinC,FangG,LiJJ,ChenP.[ObservationontherapeuticeffectofPlum Blossomneedlecombinedwithmedicatedthreadmoxibustionoftraditionalzhuang nationalitymedicineonpostherpeticneuralgia].ZhongguoZhenJiu.2010Sep; 30(9):773-6. 6.FengH,ZhangYF,DingM.[Analysisoftherapeutticeffectoflowerlimbsensationdisorder afterlumbardischerniationoperationtreatedwithPlumBlossomneedlealong meridians].ZhongguoZhenJiu.2012Feb;32(2):129-3 7.ZhongJ,LinC,FangG,LiJJ,ChenP.[ObservationontherapeuticeffectofPlum Blossomneedlecombinedwithmedicatedthreadmoxibustionoftraditionalzhuang nationalitymedicineonpostherpeticneuralgia].ZhongguoZhenJiu.2010 Sep;30(9):773-6 8.SunYZ,LiuTT.[Comparisonoftherapeuticeffectsofacupunctureandmoxibustionon diabeticperipheralneuropathies].ZhongguoZhenJiu.2005Aug;25(8):539-41. 9.YueZ.,ZhenhuiY.UlcerativecolitistreatedbyacupunctureatJiajipoints(EX-B2)andtapping withPlumBlossomneedleatSanjiaoshu(BL22)andDachangshu(BL25)--areportof43 cases.JTraditChinMed.2005Jun;25(2):83-4. 58 8. Press Tacks and Intradermal Needles Safety/Adverse Events – A Review of the Literature Presstacksandintradermalneedlesareusedfortechniquesdescribingsuperficialneedle insertionwheretheneedlesareretainedinthebodywithoutremovalforonetoseveraldays. Presstacks(enpishin),whicharetypicallyleftintheearforonetofivedays,areaformof auriculartherapy.Reportsofearstaplingforweightloss,avariantofauricularacupuncture, indicateintradermalretentionformuchlonger.(1)Intradermalneedles(hainishin)areinserted superficially,andretainedatvariousbodypoints.Intradermalneedlingisalsocalledmicro needletherapy,andisusedasaformofaesthetictreatment. Auricular Therapy/Press Tacks Auriculartherapyconsistsofpresstacks,electricalstimulation,bloodletting,oracupressure achievedwiththetapingofSemenvaccarriaseedsorsmallmagneticpelletstoearpoints.Ina systematicreviewwithmeta-analysis,auricularacupressureandauricularacupuncturewere foundtobeeffectiveforpain,(2)andinpreventingandtreatingpelvicandbackpainin pregnancy.(3)AsystematicreviewofRCTsshowedpromiseforauriculartherapyintreating chemotherapy-inducednauseaandvomitingincancerpatients(4)andinaseparatesystematic review,auriculartreatmentwasaseffectiveasdrugtherapyforperioperativeanxiety.(5) Therearemultiplecasereportsintheliteratureofchondritis(inflammationofcartilage)(6,7) andperichondritis(inflammationandinfectionoftheoverlyingskinandperichondriumofthe ear)fromauricularneedles.(8-14) Inarecentsystematicreviewnoseriousadverseeventsweredetectedandreportedevents, suchastendernessorpainatinsertionsite,dizziness,localdiscomfort,minorbleedingand nauseaforpresstacks,skinirritation,localdiscomfort,andpainforauricular electroacupunctureandminorinfectionforauricularbloodletting,wereminor.(15)The authorsofthereviewpostulatedthattheinfectedcaseswerereported20-30yearsago,and thatsingle-usesterileneedlesand“awarenessofstricthygienicprocedures”havecontributed tothelowincidenceofinfectionintheirsystematicreview.(15) Earstaplingtechniqueshavebeenadaptedfromauricularacupunctureinthetreatmentof obesity.However,sincethestaplesmayberetainedfor2-4months,thereisanincreasedrisk ofcomplicationsandinfection.(1,16,17)QualifiedtrainingandstrictCNTpracticeshouldbe followedtoavoidinfection. Intradermal Needling Intradermalneedling(Hinaishin)consistsofsuperficialinsertionandtemporaryretentionof smallneedles,typicallyaffixedtotheskinwithtape.Preoperativeintradermalacupuncturefor 59 thoracotomyhasshownequivocalresults.(18,19)Microneedlingforfacialrejuvenationhas becomemorewidelyusedwithoutdatatosupportsafety,andtherearesomereportsof complicationsandriskofcomplicationssuchasallergicgranulomatousreaction, hypersensitivity(20)andMycobacteriuminfection.(21,22)QualifiedtrainingandstrictCNT guidelinesmustbefollowed;patientself-administrationofintradermalormicroneedlesshould bediscouraged. Becausetweezersareusedforneedleplacementandbecausetheytouchthepatient’sintact skin,theycanbedisinfectedwithhospitalgradesurfacedisinfectantwipes. Safety Guidelines for the Use of Press Tacks or Intradermal Needling Critical • FollowCleanNeedleTechnique. • FollowStandardPrecautions. • FollowSafetyGuidelinesforEstablishingandMaintainingaClean Field. • FollowSafetyGuidelinesforSkinPreparation. • Cleanskinbeforeinsertingapresstack.Skincanbecleanedwith 70%isopropylalcohol,soapandwater,oranothermethod. • Inspectareatobetreatedforevidenceofinflammation,lesion, infection,orabreakinskinbarrier.Donotinsertneedlesinto theseareas. • Onlyusesingle-usesterileinstruments,includingpresstacks, whenbreakingtheskinsurface. • Maintaincleanprocedureatalltimeswhilehandlingintradermal needlespriortoinsertion.Ifneedlesbecomecontaminated,they shouldbediscarded. • Donotreinsertapresstack,intradermal,ormicroneedlethathas alreadybeeninsertedintheskin. • Instructpatientstoneverreinsertapresstack,intradermal,micro needlethathasalreadybeeninsertedintheskin. • Immediatelyisolateusedpresstacksinanappropriatesharps container. Strongly • Requestpatientsreturntotheofficesothatthepractitionercan removethepresstacksattheendofretentionofpresstacks;or Recommended providethepatientwithasharpscontainertouseathomewhen removingthepresstacksorintradermalneedles. • Advisepatientsonsaferemovalanddisposalofpresstacksor intradermalneedles. • Provideeachpatientwithdirectcontactinformationintheevent ofcomplicationsorquestions. • Instructeachpatienttoobserveandrespondtosignsofneedle complicationssuchastenderness,redness,pain,inflammation,or 60 • Recommended • • • possibleinfection. Discourageuseofpatientself-administeredpresstacks, intradermal,ormicroneedles. Forimmunocompromisedorimmunosuppressedpatients, considertheuseofearseedsormagnetsinsteadofpresstacksor intradermalneedlesforauriculartherapy. Takeacarefulpatienthistorytoidentifyifthepatientisallergicto themedicaltapeusedinthisprocedure. Afterintradermalneedlewithdrawal,applypressuretothe acupuncturepointwithcleancottonorgauze. References 1.WinterL,SpiefelJ.Earstapling:ariskyandunprovenprocedureforappetitesuppressionand weightloss.EarNoseThroatJ.2010;89(11):E20-2. 2.YehC,ChiangY,HoffmanSetal.Efficacyofauriculartherapyforpainmanagement:a systematicreviewandmeta-analysis.EvidBasedComplementAlternatMed. 2014;2014:934670. 3.PennickV,LiddleS.Interventionsforpreventingandtreatingpelvicandbackpainin pregnancy.CochraneDatabaseSystRev.2013;8(CD001139)(Aug1). 4.TanJ-Y,MolassiotisA,WangT,SuenL.CurrentEvidenceonAuricularTherapyfor Chemotherapy-InducedNauseaandVomitinginCancerPatients:ASystematicReview ofRandomizedControlledTrials.EvidBasedComplementAlternatMed. 2014;2014:430796 5.PilkingtonK,KirkwoodG,RampesH,CummingsM,RichardsonJ.Acupunctureforanxietyand anxietydisorders-asystematicliteraturereview.AcupunctureinMedicine.2007;25(12):1-10. 6.AllisonG,KravitzE.Letter:Auricularchondritissecondarytoacupuncture.NEnglJMed. 1975;293(15)(October9):780. 7.GilbertJG.Auricularcomplicationofacupuncture.NZMedJ.1987;100(819)(March11):141142. 8.BaltimoreR,MolyP.Perichondritisoftheearasacomplicationofacupuncture.Arch Otolaryngol.1976;102(9):572-3. 9.DavisO,PowellW.Auricularperichondritissecondarytoacupuncture.ArchOtolaryngol. 1985;111(11):770-1. 10.JohansenM,NielsenKO.[Perichondritisoftheearcausedbyacupuncture].UgeskrLaeger. 1990;152(3)(January15):172-173. 11.RamosS,PintoL,[Auricularperichondritisduetoacupuncture].[duetoacupuncture]. RevistaBrasilieradeOtorrinolaringologia.1997;63(6):1-589. 61 12.SorensenT.[Auricularperichondritiscausedbyacupuncturetherapy].UgeskrLaeger. 1990;152(11)(March12):752-753. 13.TrautermannHG,TrautermannH.[Perichondritisoftheearauricleafteracupuncture (author'stransl)].HNO.1981;29(9)(September):312-313. 14.Warwick-BrownNP,RichardsAE.Perichondritisoftheearfollowingacupuncture.JLaryngol Otol.1986;100(10)(October):1177-1179. 15.TanJ-Y,MolassiotisA,WangT,SuenL.AdverseEventsofAuricularTherapy:ASystematic Review.EvidBasedComplementAlternatMed.2014;2014:506758 16.BulkheadS,TonkinsonB,NowlinT.Auriculotherapycomplications:Earstaplinggonebad. Otolaryngology--HeadandNeckSurgery.2007;137:215. 17.MorganA.Pseudomonasaeruginosainfectionduetoacupuncturalearstapling.AmJInfect Control.2008;36(819):602. 18.DengG,RuschV,VickersAetal.Randomizedcontrolledtrialofaspecialacupuncture techniqueforpainafterthoracotomy.JThoracCardiovascSurg.2008;136(6):1464-1469. 19.KotaniN,HashimotoH,SatoSea.Preoperativeintradermalacupuncturereduces postoperativepain,nauseaandvomiting,analgesicrequirement,andsympathoadrenal responses.Anesthesiol.2001;95:349-356. 20.Soltani-ArabshahiR,WongJ,DuffyK,PowellD.Facialallergicgranulomatousreactionand systemichypersensitivityassociatedwithmicroneedletherapyforskinrejuvenation. JAMADermatol.2014;150(1)(Jan):68-72. 21.NohT,WoonC,LeeM,ChoiJ,LeeS,ChangS.InfectionwithMycobacteriumfortuitum duringacupointembeddingtherapy.JAmAcadDerm.2013;70(6):e134-5. 22.TangP,WalshS,MUrrayCetal.Outbreakofacupuncture-associatedcutaneous Mycobacteriumabscessusinfections.JCutanMedSurg.2006;10(4)(Jul-Aug):166-9. 62 9. Ear Seeds Safety/Adverse Events – A Review of the Literature Earseeds(sometimesalsoreferredtoas“pressballs”)areusedtostimulateacupuncture points,usuallyontheauricleoftheear,withoutbreakingtheskin.Mostaremadefrommetals suchassurgicalstainlesssteelormagnets.Traditionally,seedsfromplantssuchasCaryophyllus aromaticus(clove)andVaccariahispanica(cowherb),wereusedthusgivingthename “vaccaria”toallsuchearseeds.Thesemetal(ornaturallyoccurring)seedscanbeusedto stimulatepointsinotherareasofthebody,suchasatNeiguan(P6)fornauseaofpregnancy andmotionsickness. TherearenoprospectivestudiesorretrospectivereviewsintheEnglishliteratureregardingthe safetyoftheuseofearseeds/vaccaria.Thereareafewstudieswhichreviewedtheusesofand therapeuticeffectsofearseedsforbackpain,(1)weightloss,(2)andconstipation.(3) Thesestudiesreviewedpatientacceptanceandtherapeuticoutcomeswithseedsbeingleftin forupto7days.NonereportedAEsorpatientintolerance. Preventing Ear Seed Adverse Events TherearenocommonAEsassociatedwiththeuseofearseeds/vaccaria.Generalclean techniquesandvigilancetoavoiduseoftheseedswherethereisanactiveskininfectionor traumashouldbesufficienttomaintainthesafetyrecordofvaccariatreatments. Safety Guidelines for the Use of Ear Seeds Recommended Takeacarefulpatienthistorytoidentifyifthepatientisallergictothe medicaltapeusedinthisprocedure. References 1.YehCH,ChienLC,ChiangYC,HuangLC.Auricularpointacupressureforchroniclowbackpain: afeasibilitystudyfor1-weektreatment.EvidBasedComplementAlternat Med.2012;2012:383257.doi:10.1155/2012/383257.Epub2012Jul1. 2.HsiehCH.Theeffectsofauricularacupressureonweightlossandserumlipidlevelsin overweightadolescents.AmJChinMed.2010;38(4):675-82. 3.ZhouXX,ZhongY,TengJ.[Senilehabitualconstipationtreatedwithauriculartherapybased onthepattern/syndromedifferentiation:arandomizedcontrolledtrial].ZhongguoZhen Jiu.2012Dec;32(12):1090-2. 63 10. Tui Na Safety/Adverse Events – A Review of the Literature TuinaisamanualtherapywhichusesChinesemassageandmanipulationtechniques.Thereare noprospectivestudiesorretrospectivereviewsintheEnglishliteratureregardingthesafetyof theuseoftuina.TuinaisextensivelyusedinChinaforavarietyofpainandmusculoskeletal syndromes.Arecentstudywhichreviewedtheusesofandtherapeuticeffectsoftuinaforpain (1)andParkinson’sdisease(2)foundnoadverseeventsorreactionsassociatedwithtuina therapy. Similarly,aCochranereviewoftheuseofmassage(nottuina)forneckpain(3)reported infrequentreportsofpost-treatmentpainandrareoccurrencesoflowbloodpressurefollowing massageassideeffects. Arecentpractitionerjournalarticlelistedthefollowingcontraindicationstotuina:(4) • • • • • • Wounds Dematoses Diseaseswithhemorrhagictendencies Acuteinfectiousdiseases Diseasesofthebrain,heart,liver,kidney,andotherviscera Menstruationandpregnancy ThislistissimilartothatusedbymassagetherapistssincethetimeofJHKelloggwhoin1895 listedthefollowingcontraindicationstomassage:(5) Massageiscontra-indicatedinnearlyallformsofskindisease,exceptinthickened conditionoftheskinleftbehindbychroniceczema.Itisalsocontra-indicatedinacute casesofapoplexyandintheearlystagesofneuritis,whenirritabilitystillexists,and shouldneverbeadministeredtoabscesses,tumorsortubercularjoints. Amorerecentarticleoncreatingstandardsformassageinthehospitalsettingalsoelucidated similarprecautions:(6) Contraindicationsandcautions:UndertheUMHSpolicy,therapeuticmassageislocally contraindicatedinornearareasofinfection,tumors,orincisions.Other contraindicationsincludebutarenotlimitedtoimpairmentbyalcoholordrugs,the presenceofcontagiousrashes,andfailureofthepatienttoconsenttomassagetherapy. ThereareafewofcasesreportedAEs(complications)associatedwithtuinaintheChinese languagemedicalliterature.Mostofthesecasesareduetoimproperuseofforceduringthetui 64 napracticewhichledtosuchAEsassofttissueinjury,peripheralnerveinjury,visceralinjury, dislocationofajoint,bonefracture,epiduralhemorrhage,injuryofcentralnervesystem especiallycervicalspineinjury,etc.(7-10)Itisclearthatwhilethesearerareoccurrences, properunderstandingofanatomyandphysiologyisneededtopreventAEsassociatedwiththe over-useofforce. Preventing Tui Na Adverse Events TherearenocommonAEsassociatedwiththeuseoftuina.Generalcleantechniquesand vigilancetoavoidusingtuinawherethereareactiveskininfections,openwounds,fractures,or acutetrauma,andconsultationwithotherphysicianswhenusingthetechniqueaftersurgeryor duringtreatmentsforcancershouldbesufficienttomaintainthesafetyrecordofthis procedure. Safety Guidelines for Tui Na Critical • FollowSafetyGuidelinesforHandSanitation. • Neverapplytuinatoareasthathavedermatitis,activelesionsor otherwounds. Strongly • Provideappropriatepressureandadjusttuinatreatments Recommended accordingtoage,location,bodyconstitutionandmedicalhistory. References 1.PangJ,TangHL,GaoLF,WangKL,LeiLM,LiuZW,GanW,LuY,ZhouHF,LiJS,ZhangQM. [RandomizedcontrolledtrialoneffectofTuinafortreatmentofsub-healthpeopleof somaticpain].ZhongguoZhenJiu.2010Jan;30(1):55-9. 2.Walton-Hadlock,J.PrimaryParkinson'sdisease:TheuseofTuinaandacupunctureinaccord withanevolvinghypothesisofitscausefromtheperspectiveofChinesetraditional medicine.AmericanJournalofAcupuncture1998;26(2-3):163-177 3.PatelKC,GrossA,GrahamN,GoldsmithCH,EzzoJ,MorienA,PelosoPM.Massagefor mechanicalneckdisorders.CochraneDatabaseSystRev.2012Sep12;9:CD004871.doi: 10.1002/14651858.CD004871.pub4. 4.Indications,ContraindicationsandPointsforAttentioninTuina. http://tcmdiscovery.com/Tuina-Massage/info/20080913_214.htmlAccessedDecember 2012. 5.Kellog,JH.TheArtofMassage.ModernMedicinePublishingCo.,BattleCreek,MI.,1895. P.201 6.MyklebustM,IlerJ.Policyfortherapeuticmassageinanacademichealthcenter:amodelfor standardpolicydevelopment.JAlternComplementMed.2007May;13(4):471-5. 65 7.Chi,Shulan,etal.淑兰,等.急性腰扭伤按摩致腰部血肿一例.颈腰痛杂志,1995;16(2):90. Acase ofhematomaatthewaistassociatedwithmassagefortreatingacutelumbarsprain.The JournalofCervicodyniaandLumbodynia,Vol.16,no.2,p.90,1995.[ArticleinChinese] 8.Zhu,Yonghui.朱永辉.颈椎按摩致瘫痪1例报告.岭南急诊医学杂志,2001,6(1):69. Acasereport ofparalysisassociatedwithmassageatcervicalspine.LingnanJournalofEmergency Medicine,Vol.6,no.1,p.69,2001.[ArticleinChinese] 9.Zeng,Shengming.曾胜明.推拿治疗肩周炎致肋骨骨折一例.中国疗养医学,2001;lO(1):3. A caseofribfracturesassociatedwithTuina(Chinesemassage)treatmentforfrozen shoulder.ChineseJournalofConvalescentMedicine,Vol.10,No.1,p.3,2001.[Articlein Chinese] 10.Xiong,Guanyu.熊冠宇.手法治疗颈椎病致脑干梗塞l例.河南中医,2003;23(1 0):7. Acaseof brainsteminfarctionassociatedwithmanualtherapyforcervicalspondylosis.”Henan TraditionalChineseMedicine,Vol.23,no.10,p.7,2003.[ArticleinChinese] 66 11. Other Acupuncture-Related Tools Manaka/Japanese Acupuncture Tools A Review of the Literature ThereisnoevidenceintheEnglishlanguagemedicaldatabasesthatthereareanyAEs associatedwitheitherManakapumpingchordsorManakahammertreatments. Preventing Adverse Events TherearenocommonAEsassociatedwiththeuseofManakaproducts.Generalclean techniquesandvigilancetoavoiduseoftheManakapumpingchordsorManakahammer wherethereisanactiveskininfectionortraumashouldbesufficienttomaintainthesafety recordofthesetreatments. Shonishin Pediatric Japanese Acupuncture Tools A Review of the Literature ThereisnoevidenceintheEnglishlanguagemedicaldatabasesthatthereareanyAEs associatedwithShonishintreatments. Preventing Common Adverse Events TherearenocommonAEsassociatedwiththeuseofShonishinproducts.Generalclean techniques,properdisinfectionofsuchdevicesasnoncriticaldevices,andvigilancetoavoiduse oftheanyreusablemedicaldevicewherethereisanactiveskininfectionortraumashouldbe sufficienttomaintainthesafetyrecordofthesetreatments. 67 Part II: Best Practices for Acupuncture - CNT Thereareawidevarietyofapplicationsandtechniquesforallacupunctureprocedures.Many followoraltraditions.ThefollowingrecommendationsutilizepracticesasdescribedinChinese AcupunctureandMoxibustion(1)andAcupuncture–AComprehensiveText(2),andapplysafety practicesbasedontheevidencefromPartI.Thereareanynumberofothermethodswith safetyprotocolsapplicabletovariousstylesofacupuncturepractices.Thissectionisnotmeant tobeexhaustiveorprohibitive,butrathertobeinstructive.Schoolsandpractitionersare encouragedtoimplementadditionalandalternativemethodstoreduceriskutilizingadditional andalternativeneedlingtechniques,moxaapplications,andpracticesutilizingotherAOM clinicaltraditions.See,forinstance,thediscussionofToyoharicontactneedlingacupuncture. Forthepurposesofthismanual,thefollowingtermswillbeutilizedtohelppractitionersapply bestpracticestotheirpersonalpractices:critical,stronglyrecommendedandrecommended. SeetheIntroductionforexplanationoftheseterms. 1. CNT Protocol CleanNeedleTechnique(CNT)isthestandardbywhichacupuncturistspreventoccupational exposuretohealthcareassociatedpathogens,includingbloodbornepathogensandsurface pathogens,andreducetheriskforsomeotheradverseeventsassociatedwithacupuncture. CNTconsistsofthefollowingcomponents: 1. 2. 3. 4. 5. 6. Handsanitation. Establishingandmaintainingacleanfield. Skinpreparation. Isolationofcontaminatedsharps. Standardprecautions. Theuseofsterilesingle-useneedlesandotherinstrumentsthatmaybreaktheskin, suchasseven-starhammers,presstacks/intradermalneedles,andlancets. Inaddition,asneeded: 7. Followappropriateemergencyproceduresintheeventofaneedlestickincidentor someotherclinicalaccidentinthecourseofanacupuncturetreatment. Itshouldbestatedattheoutsetthatamorecomprehensiveriskmanagementprotocolis beyondthescopeofthismanual.Anyriskmanagementcourseshouldbeadaptedtothe uniquerequirementsofthespecificacupuncturetreatmentenvironmentinwhichthe acupuncturististreatingpatients. 68 CleanNeedleTechniquemustbedistinguishedfromsteriletechnique.Sterileoraseptic technique,whichisusedinsurgicalproceduresandmanylaboratoryprocedures,involves proceduresthatarekeptsterilebytheappropriateuseofsterilesuppliesandthemaintenance ofasterilefield.Whileacupunctureinvolvestheuseofsterileacupunctureneedlesthatmust bemaintainedinasterileconditionpriortotheacupunctureprocedure,CNTisacleanrather thansterileprocedure. Theinsertionsiteiscleanratherthansterile.Handsareinacleanconditionratherthancovered withsterilegloves.Glovesdonotneedtobewornexceptunderspecificconditionswhere exposureofthepractitionertobloodorotherpotentiallyinfectedbodyfluidsispossible. Glovesareworn: 1. Whenbleedingoccurs,orislikelytooccur(e.g.,duringbleedingtechniques,wet cuppingandseven-star/plumblossomtreatments). 2. Whenneedlinginthegenitalregionorinthemouth. 3. Whilepalpatingnearanareawheretherearelesionsonthepatient’sskin. 4. Intheeventthatthereareskinlesionsoropenwoundsontheacupuncturist’shands. 5. WhencleaningbloodorOPIMfromasurface. Hand Sanitation HandwashingisacriticalcomponentoftheCNTprotocol.Washinghandswithsoapandwater isthebestwaytoreducethenumberofmicrobesontheminmostsituations.Ifsoapandwater arenotavailable,useanalcohol-basedhandsanitizerthatcontainsatleast60%alcohol.(3) Makesuretouseenoughsanitizerthatthehandsarecompletelycoveredandwet.Washhands ratherthanusehandsanitizerifhandsarevisiblydirty. Safety Guidelines for Hand Sanitation Critical • • • • • Followinstructionsfor“HowtoWashHands”or“HowtoUseHand Sanitizer.” Ifusinghandsanitizer,usesanitizerthatcontainsatleast60%alcohol uponenteringaroomwithapatientandaftertouchingortreatinga patient. DONOTusealcohol-basedhandproductstowashhandsafterexposure ofnon-intactskintobloodorbodyfluids;insuchcases,washhands withantibacterialorplainsoapandrunningwater,thendrythemusing single-usepapertowels. Washhandsuponenteringapatient’sroom. Washhandsimmediatelypriortoinsertingacupunctureneedlesor performingotherclinicalprocedures.Ifhandscomeintocontactwith suchitemsasclothes,keyboards,hair,skin,pens,orcharts,rewash 69 hands. Washhandsaftertouchingortreatingapatient. Washhandsbeforeandaftereating. Washhandswithsoapandwaterafterusingtherestroom. Washhandsaftercoughingorsneezing. Gloveforprocedureswheretheremaybeexposuretobloodorbody fluid. Removeglovesimmediatelyafterexposure.Washhandsorsanitize. • • • • • • How to Wash Hands(4) Critical • • • • • • • Wetyourhandswithclean,runningwater(neutralorwarm)andapply soap. Latheryourhandsbyrubbingthemtogetherwiththesoap.Besureto latherthebacksofyourhands,betweenyourfingers,andunderyour nails. Scrubyourhandsfor10-20seconds. Rinseyourhandswellunderclean,runningwater,withyourhandslower thanyourelbows. Dryyourhandsusingacleanpapertowel. Turnoffthefaucetusingapapertowel. Openanydoorsbetweenyouandyourpatientsusingapapertowel,orrecleanhandsuponenteringthepatient’sroom. How to Use Hand Sanitizer(3) Critical • • • Applytheproducttothepalmofonehand(readthelabeltolearnthe correctamount). Rubyourhandstogether. Rubtheproductoverallsurfacesofyourhandsandfingersuntilyour handsaredry. Preparing and Maintaining a Clean Field Acleanfieldistheareathathasbeenpreparedtocontaintheequipmentnecessaryfor acupunctureinsuchawayastoreducethepossiblecontaminationofsterileneedlesandother cleanorsterileequipment. Safety Guidelines for Preparing and Maintaining a Clean Field Critical • • FollowSafetyGuidelinesforHandSanitation. Selectaclean,dry,flatsurfacetoserveasthesettingforthe 70 • • • • Strongly Recommended • • • • cleanfield.Atreatmenttableisnotsuitable. Establishanewcleanfieldforeachpatient. Placematerialssuchasacupunctureneedlesinblisterpackson thecleanfield. Placecleancottonballsorunopenedswabsonthefield.If desired,theseitemsmaybekeptinacleanjarneartheclean field. Cleanthesurfaceusedforthecleanfieldwithalow-level disinfectantatleastoncedaily. Placecleancottonballsorunopenedswabsonthecleanfield.If desired,theseitemsmaybekeptinacleanjarneartheclean field. Keepsterileitemsnearthecenterofthecleanfieldwithclean itemsnearertheedges. Cleanblisterpacksofsterileneedlesmaybehandledand replacedbackontothecleanfield. Cleanpreviouslysterilizedguidetubesmaybehandledand replacedbackontothecleanfield. Skin Preparation Acupunctureneedlesshouldbeusedonlywheretheskiniscleanandfreeofdisease. Acupunctureneedlesshouldneverbeinsertedthroughinflamed,irritated,diseased,orbroken skin.Otherwise,infectionscanbecarrieddirectlyintothebodypastthebrokenskinbarrier. Theareastobeneedledshouldbecleanpriortotreatment.Alcoholswabbingisrecommended butnotessentialbeforeacupunctureneedleinsertionaslongasanareaisclean.Ifswabbingan area,70%alcoholorethanolisrequired.Skincanbecleanedwith70%isopropylalcohol,soap andwater,orothermethodsasdeterminedbythepractitionerorclinicadministrator.While soapandwatermaybeacceptable,manypatientscomeinfortreatmentafterworkand treatmentisoftengiventoareasofthebodywheresoapandwaterarenotpracticalinthe office.Inmostcases,itispracticaltocleantheskintobeneedledwithanalcohol-impregnated swab.Ifbodyparts(e.g.,thefeet)aregrosslydirty,theyshouldbewashedwithsoapandwater oranappropriatecleansingcloth.Thepractitionermaythendeterminewhethertheskinalso needstobeswabbedasneededwithanalcoholswaborothercleansingagent. AccordingtotheWorldHealthOrganization,bothsoapandwaterand60-70%isopropyl(or ethanol)alcoholisadequateforpreparingapatient’sskinforproceduressuchasneedle insertion.(5)Isopropylalcoholataconcentrationabove70%isunacceptablebecauseit evaporatestooquicklytohaveanantisepticeffect. 71 Therearenostudieswhichcompareskinpreparationpriortoacupunctureneedleinsertion withnoskinpreparation.Theclosestinformationavailablepertainstoskinpreparationpriorto injections,(6)suchasinsulininjectionsfordiabeticsandvaccinations.Researchconductedas earlyasthe1960sbyDann(7)andKoivisto&Felig(8)withdiabeticpatientsindicatedthat althoughskinpreparationwithalcoholpriortoinjectionmarkedlyreducedskinbacterial counts,suchtreatmentisnotnecessarytopreventinfectionatinjectionsites.(9) Manypractitionersbelieveitfollowsbestpracticeguidelinestocleantheskinpriortoinjection toreducetheriskofcontaminationfromthepatient’stransientskinflora.TheNIH,inits patientinstructions,clearlystates,“Sincetheskinisthebody’sfirstdefenseagainstinfection,it mustbecleansedthoroughlybeforeaneedleisinserted.”(10) Skinthatiscurrentlyinflamed,orwhichhasanactivelesionshouldnotbeusedforneedle insertion.Theseareasoftencarryhigherriskforinfection.AccordingtoNIHguidelines, “injectionsarenotgiveniftheskinisburned,hardened,inflamed,swollen,ordamaged...” (10) Theevidencesuggeststhatboththepractitioner’shandsandthepatient’sskinatthe acupuncturepointneedtobecleanpriortoadministrationofaneedle,whetherthatneedleis beinginsertedtoanintradermal,subcutaneous,orintramusculardepth.Riskassessmentof potentiallycontaminatedskinshouldbeconductedtoensureappropriatecleaningoftheskinis undertakenwhererequired.Inotherwords,ifsoiled,thepatient’sskinshouldbecleanedprior toneedleinsertion.Thereisnoclearevidencethatskincleansingwithsoapandwater,alcohol swabs,orantibacterialsubstanceslikechlorhexidineisbetterorworsethantheotheroptions. Evenifskinisvisiblyclean,milddisinfectionmaystillbeperformedpriortoneedleinsertionas allOPIM(otherpotentiallyinfectiousmaterials)arenotnecessarilyvisibletothenakedeye. Iftheinsertionsiteiscleanedwithanalcoholswab,itshouldbeallowedtodrypriortoneedle insertiontopreventpainfromalcoholbeinginsertedundertheskinalongwiththe acupunctureneedle. Somestatesmandatedtheuseofanantisepticswabbeforeinsertionofanacupunctureneedle intheirpracticeactsand/orrules.Thismanualshouldnotbeinterpretedasadvisingagainsta practiceoutlinedinstatelaw.Practitionershaveadutytoinvestigateandcomplywithstate regulation.Foramoredetaileddiscussionofthistopic,seeCCAOM’spositionpaperonskin preparationinPartIVofthismanual. Alcohol Swab Method Swabthepointsandallowthealcoholontheskintodry.Thesameswabmaybeusedfor severalpoints.Anewswabshouldbeusediftheswabbeginstochangecolor,becomesvisibly 72 dirty,becomesdry,orhascomeintocontactwithanyskinbreak,lesion,inflammationor infection.Thealcoholshouldbeallowedtodrytoreducethepotentialfordiscomfortduring needling.Aseparateswabshouldbeusedforareasofhighbacterialload,suchasaxillaor groin. Safety Guidelines for Skin Preparation Critical • • • • • • • • Strongly Recommended • • • Recommended • • FollowSafetyGuidelinesforHandSanitation. Inspectareatobetreatedforvisibledirtorsoiling.Soapandwater washingisrequiredforvisiblysoiledareas. Inspectareatobetreatedforevidenceofinflammation,lesion,and infectionorbreakinskinbarrier.Donotinsertneedlesintothese areas. Alcoholswabbingcontinuestoberecommendedforintramuscular needlepenetration.(5) Ifalcoholswabsareused,70%isopropylorethanolalcoholis required. Ifalcoholswabbingisusedtocleanpointsbeforeneedleinsertion, allowthealcoholontheskintodry. Donotuseaswabatanyadditionalsiteifithascomeintocontact withskinthathasvisibleinflammation,lesion,andinfectionorbreak inskinbarrier. Aseparateswabshouldbeusedforareasofthebodythathavehigh bacterialload. Donotreuseanalcoholswabonanotherpatient. Donotpre-soakcottonwoolinacontainerasthesebecomehighly contaminatedwithhandandenvironmentalbacteria. Thesamealcoholswabmaybeusedforcleaningseveralpointsitesas longastheswabitselfhasnotdried,hasnotchangedcolororbecome visiblydirtyandhasonlycomeintocontactwithintactskin. Alcoholswabbingofareastobetreatedwithintradermalor subcutaneousmethodsisrecommendedbutnotessentialaslongas theareaappearstobeclean.(5) Investigateandfollowlocalandstateregulationconcerningskin preparation. Isolation of Used Sharps AnothercriticalcomponentofCNTistheisolationofusedsharps.Sharpsshouldbeisolatedina sharpscontainerspecificallydesignedforthisuse.Appropriatecontainersareavailable commercially.Sharpscontainersaremadeofamaterialimpervioustoneedlesandfluids,such asplastic,andaredesignedtoreceivecontaminatedsharpswithoutbeingabletoretrievethem 73 afterthesharpsareplacedinthecontainer.Thesecontainersarelabeledastocontentsand bearthebiohazardsymbol. Standard Precautions StandardPrecautionsareoutlinedbytheCentersforDiseaseControl.(11)Forthoseusedtothe termUniversalPrecautions,StandardPrecautionscombinethemajorfeaturesofUniversal Precautions(UP)andBodySubstanceIsolation(BSI),andarebasedontheprinciplethatall blood,bodyfluids,secretions,excretionsexceptsweat,non-intactskin,andmucous membranesmaycontaintransmissibleinfectiousagents.StandardPrecautionsincludeagroup ofinfectionpreventionpracticesthatapplytoallpatients,regardlessofsuspectedorconfirmed infectionstatus,inanysettinginwhichhealthcareisdelivered.Theseinclude:handhygiene; useofgloves,gown,mask,eyeprotection,orfaceshield,dependingontheanticipated exposure;andsafeinjectionpractices.(TheCDCswitchedfromthetermUniversalPrecautions toStandardPrecautionsin2007.) StandardPrecautionsarewidelyusedtopreventexposuretopotentiallyinfectiousmaterialsin thecourseofclinicalwork,includingacupuncture.Theseprecautionsaresummarizedbelow: 1. Assumeallpatientsareapotentialsourceofinfection. 2. Utilizecorrectandfrequenthandwashing. 3. Allhealthcarepractitionersmustunderstandtheappropriateuseofpersonalprotective equipment(PPE)suchasgloves,eyeprotection,andmasks. 4. Healthcarefacilitiesapplyappropriateengineeringcontrols,suchasproperlyequipped handwashingstations. 5. Isolationofsharpsinappropriatesharpscontainers. 6. Isolationofcontaminatedmedicalwasteinaredbagorotherappropriatecontainer. 7. Correctuseofdisinfectants. 8. Appropriatecautionwhenhandlingsharps,includingacupunctureneedles,seven-star hammers,andlancets. Basic Steps of the Clean Needle Technique for Acupuncture 1. TheproviderfollowsSafetyGuidelinesonHandSanitation. 2. Acleanfieldissetuponastablesurfacenearthetreatmenttable.Thecleanfieldmay consistofapieceofpapertoweling,tablepaper,acleanmetaltrayeitherpreparedwith apaperbarrierorcleanedwithanappropriatedisinfectantbetweeneachpatientvisit, oracleanfieldpurchasedforthispurpose. 3. Needles,intheiroriginalpackaging,areplacedonthecenterofthecleanfield. 74 4. Non-sterilecottonballsandskincleansingmaterials(e.g.,alcoholswabs)areplaced eithernearbythetreatmenttableinacleancontainerorontheperipheryoftheclean field. 5. Sharpsandtrashcontainersareplacedawayfromthecleanfield. 6. Theacupuncturepointsonthepatient’sskinshouldbeclean.ForthepurposesofClean NeedleTechnique,skincanbecleanedwith70%isopropylalcohol,soapandwater,or anothermethodbutmustbecleanwheninsertinganeedleorlancet. 7. Ifusingalcoholtocleantheskin,useanewswab/cottonballwheneverthealcoholswab becomesdirtyorcontaminatedoristoodrytoleaveathinlayerofalcoholsolutionon theskin.Theinsertionpointcanthenbepalpatedwiththewashedfinger. 8. Theneedleshouldbeinsertedwithouttouchingitssterileshaft.Shouldtheneedlebe long,suchasathreetosixinchneedle,theshaftmaybeheldwithsterilegauzeor sterilecottonbetweenthefingersandtheneedleshaft.Inserttheneedleonlyonce.In theeventthattheneedlelocationischanged,theneedleshouldbewithdrawnand placedinthesharpscontainer.Anewneedlemustbeusedforeachinsertion. 9. Theneedleisthenstimulatedfortherapeuticeffect. 10. Aftertheappropriateamountoftime,theneedleshouldbewithdrawnandplacedina sharpscontainer.Donotplacetheneedleinatrayforlatertransfertothesharps containerasthisincreasestheriskofanaccidentalneedlestick.Donothandtheused needletoanassistant.Thistransferalsoincreasestheriskofexposurebyaccidental needlestick. 11. Attheendoftreatment,thepractitionerwasheshisorherhandsandcleansupthe cleanfield,includingreplacingordisposingofunusedsupplies.Intheeventthatthe practitionerhasusedsome,butnotall,oftheneedlesinamulti-packofacupuncture needles,allunusedneedlesmustalsobedisposedofinthesharpscontainer.Opened needlepacksmaynotbeusedforadifferentpatientoratreatmentatalatertime. 75 2. CNT Basic Principles CleanNeedleTechnique(CNT)includesthefollowingbasicprinciples: 1. Alwayswashhandsbetweenpatients,andbeforeandafterneedling. 2. Alwaysestablishacleanfieldbeforeperformingacupuncture. 3. Alwaysusesterilesingle-useneedlesandotherinstrumentsthatmaybreaktheskin, suchasseven-starhammers,presstacks/intradermalneedles,andlancets. 4. Alwaysimmediatelyisolateusedneedlesandothersharps. 5. FollowStandardPrecautions. Besidestheobviousnecessityforsterileneedles,lancets,andseven-starhammers, handwashingisthesinglemostimportantactioninpreventingcross-infection.Handsshouldbe washedwithliquidsoapunderrunningwaterbetweenpatients,aswellasbeforeandafter performingacupunctureorotherprocedures,andwheneverthepractitioner’shandsmayhave becomecontaminatedwithpotentiallyinfectiousmaterial.(SeesectiononhandwashinginPart Vofthismanual.)Potentialsourcesofcontaminationincludetouchingthehair,clothes,or uncleanskinofthepatient(orpractitioner);paperwork;computersorphones;oranyother uncleansurfaceorobjectinthetreatmentenvironment.ThemaingoalofStandardPrecautions issafetyandspecificallythepreventionofexposuretoandtransmissionofnosocomialdisease. Intheeventthatitisimpracticalorimpossibleforthepractitionertowashhisorherhands withsoapandwater,analcohol-basedhandsanitizermaymaybesubstituted.Alcohol-based handsanitizersareeffectiveforreducingthepresenceofpotentiallyinfectiousagentsbutwill notbeeffectiveintheeventthatthepractitioner’shandsaresoiled.Whenthepractitioner’s handsaresoiled,washinghandswithsoapandwaterremainsthebestwaytoremove contamination.TheCDCalsoallowsfortheuseofdisinfectinghandwipeswhensoapandwater handwashingisnotanoption.Forproperuseofalcohol-basedhandsanitizersanddisinfecting handwipes,pleaseseethemanufacturer’sinstructions. Contaminatedneedlesarethegreatestsourceofinfectionrisktothepractitionerandpatient. Itisessentialtominimizehandlingofusedneedlesduringdisposal.Thesebasicprincipleswill bediscussedinthesectionsthatfollow.Itisessentialtobemeticulousinfollowingallaspects ofCleanNeedleTechniqueprotocolandStandardPrecautions.Thisincludestheuseofsterile needles,handwashingbetweentreatments,andisolationofusedsharps.Skinandmucus membranecontactsfrequentlycanbepreventedwiththeuseofbarrierprecautionssuchas gloves,masks,gowns,andgoggleswhennecessary;however,thegreatestriskofbloodborne pathogentransmissioncomesfromneedlestickinjuries.Suchaccidentsarenotpreventedby barriersbutinsteadrequirestrictadherencetoCNTprotocolsbypractitioners,includingthe immediateisolationofusedsharps,thecontinuingrecognitionoftheneedtohandleall 76 patientsasiftheywerepotentiallyinfectious,andtheneedtotrainallstaffincleanneedle protocolsandStandardPrecautions. PrecautionsarethesameforhepatitisandAIDSaswellasforotherdiseasesthatmightbe transmittedbyneedlestickaccidents.Healthcareworkersareadvisedtodevelopstandardand habitualproceduresforallpatientsthatprovidethenecessaryprotectionagainstthe transmissionofpotentiallyinfectiousagents.(12) Setting Up the Clean Field Acleanfieldistheareathathasbeenpreparedtocontaintheequipmentnecessaryfor acupunctureinsuchawayastoreducethepossiblecontaminationofsterileneedlesandother cleanorsterileequipment. Acleanfieldforacupunctureneedlingisestablishedinthetreatmentsettingbyplacingaclean papertowel,cleantablepaperorothercleanbarrierthatwillserveasacleanfieldonan appropriateworksurface.(Ifatrayisusedasthecleanfield,itmustbecleanedwithan appropriatedisinfectantbetweeneachpatientvisitorcoveredwithcleanpaperorother barrierforeachpatientvisit.)Thisfieldshouldbeusedforneedles(beforeuse)andanyclean itemsthepractitionerneedscloseathandforneedlingandotherprocedures.Thecleanfield shouldbechangedaftereachtreatmentsession.Theworksurfaceusedforthecleanfield shouldbecleanedatleastoncedailyusingappropriatelow-leveldisinfectants. PhotobyDarleneEastonandMorrisHoughton. 77 Inspecting Needle Packaging Prior to Use Priortouse,acupuncturepractitionersneedtoinspectthepackagingofanysingle-usesterile needles(andothersterilesharps)toensurethattheprotectivebarrierhasnotbeenbreached ordamagedbyexposuretowater.Theexpirationdateofallneedlesinaclinicshouldbe checkedregularly(i.e.,monthly)andallexpiredneedlesbediscarded.Discardanypackageof needlesthathasbeenpunctured,tornordamaged,orpasttheexpirationdateofsterilization. Whenusingacupunctureneedlesfrompackagesthatcontainmorethanoneneedle,allneedles leftoverattheendofatreatmentmustalsobetreatedasnon-sterilesharpsandmust thereforebediscardedinanappropriatesharpscontainer.Anyunusedbutunsterileneedles shouldnotbesetasideforuselaterinthedayonadifferentpatientorforuseonthesame patientonadifferentday.Theyshouldbetreatedascontaminatedsharpsanddiscarded appropriately.Thisshouldnotpreventapractitionerfromusingthemulti-needlepackagesif thatishisorherpreference;propercleantechniquecanstillbefollowedusingthistypeof needlepackaging. Skin Preparation Acupunctureneedlesshouldbeusedonlywheretheskiniscleanandfreeofdisease. Acupunctureneedlesshouldneverbeinsertedthroughinflamed,irritated,diseased,orbroken skin.Otherwise,infectionscanbecarrieddirectlyintothebodypastthebrokenskinbarrier. Theareastobeneedledshouldbecleanpriortotreatment.Alcoholswabbingisrecommended butnotessentialbeforeacupunctureneedleinsertionaslongasanareaisclean.Ifswabbingan area,70%alcoholorethanolisrequired.Skincanbecleanedwith70%isopropylalcohol,soap andwater,oranothermethodasdeterminedbythepractitionerorclinicadministrator.See SafetyGuidelinesforSkinPreparation. Palpating the Point Itisacceptablecleantechniquetopalpatetheacupuncturepointaftercleaningtheskin,aslong asthehandsarecleanandhavenotbeencontaminated.However,itisstronglyrecommended thatbeforepickinguptheneedleorpalpatingthepoint,thehandsshouldbewashedwithsoap andwateroranalcohol-basedhandsanitizeriftheyhavebeencontaminatedsincethelast handwashingbysomeactivitysuchasarrangingclothingortakingnotes.Afterthissecond cleaningofthehands,nothingshouldbetouchedbuttheneedlehandle,guidetube,andthe skinoverthepoint.Ifanythingelseistouched,thefingersshouldbecleanedagainasdescribed abovebeforeproceeding. 78 Inserting Needle to Correct Depth Whilethereisnoabsolutestandardforthedepthofacupunctureneedling,therearestudieson methodsofestablishingsafedepths(13)andrecommendationsfromreliablepractice textbooks.(1,2,14)Followingaresomegeneralguidelinesandrecommendations: 1. Followthesuggestedneedledepthsindicatedinstandardtexts,beingsuretoallowfor variationinbodysize,age,underlyingdiseaseandriskfactors.Forinstance,in puncturingthepointRen12(Zhongwan),astrongsensationmaybeobtainedwhena depthof0.5inchisreachedinathinpatient.Ontheotherhand,sensationmayonlybe inducedwhentheneedleisinsertedtoadeeperlevelforanobesepatient.Clinical carefulanalysisshouldbemadeofeachpatient.Forchildren,needledepthsshouldbe lessthanforanadult. 2. Safeneedlingdepthofthethoracicregiontoavoidpneumothoraxandcardiac tamponadeonmostpatientscanbeaslittleas10-20mm.Limitingthedepthof acupunctureneedleinsertiontothesubcutaneouslayeriscriticalandavoidinguseof needlesthatarelongerthanthesafeneedlingdepthforaparticularbodyareais stronglyrecommended.(SeeSafetyGuidelinestoAvoidaPneumothorax,OrganInjury, andTraumaticTissueInjury) 3. Softtissueabdominaldepthsinanadultcanvaryfrom2-4cm.andwillbelessifthe patientisthinorthetissueiscompressedbypalpation.(15) Can I touch the needle during needle insertion? Ifyouneedtosupporttheshaftoftheneedleduringneedleinsertion,eitherbecauseyouare usingathinneedle(e.g.,0.15mmwidth)oralongneedle(e.g.,morethan25mmlength)or both,youmustuseasterilebarrierbetweenyourfingersandtheshaftoftheneedle.While washingyourhandsremovesmostofthetransientbacteriafromtheskinofthehandsand fingers,itdoesnotdislodgetheresidentbacteria.Somepeoplecarryresidentbacteriaontheir skinthatispathogenictootherpeople,suchasMRSA.(SeeinformationaboutHealthcare AssociatedInfections,PartIV,formoreinformationaboutskinbacteria;andPartVofthis Manualformoreinformationabouthandwashing.)Anyobjectthatpiercestheskinmustbe sterile.Tosupporttheshaftoftheneedle,whennecessary,usesterilegauzeorsterilecotton betweenyourfingersandtheneedleshaft;thendiscardthegauzeorcottonaftercompleting theneedleinsertion.Thiswillgreatlyreducethepossibilityofcrossinfections(practitionerto patient)fromacupunctureneedling.Whilemanyolderpractitionersdoholdtheneedleshaft withtheirclean(butnotsterile)hands,thispracticeistobestronglydiscouragedinthose followingtherulesofbestpractices. 79 Needle Removal Therearenospecificstandardsregardingneedleremovaltechniques.Whilesomewillfind usingaone-handedmethod(usethesamehandtowithdrawtheneedleandcoverthepoint withcotton)lesslikelytocauseaneedlestickthana2-handedmethod(usedifferenthandsfor needleremovalandcoveringthepointwithacottonball),nospecificstudieshaveshown eithermethodasbeingsuperior. Similarly,therearenostudiesidentifyingthesafestmethodforneedleremoval.Whileitisclear thatremovedneedlesneedtobeplacedimmediatelyintoasharpscontainer,thereisno evidenceindicatingthatneedlesmustberemovedandplacedinasharpscontaineroneata time.Limitingtimeanddistancebetweenremovingtheneedleandplacingusedneedlesina sharpscontainerisstronglyrecommended.Walkingaroundorgesticulatingwithusedneedles inyourhandsneedstobeavoidedasmuchaspossible. Alwaysuseacottonballorotherclean,absorbentmaterials(swab,gauze)forcoveringthehole afterneedleremoval;neveruseyourhandorfinger.Somebloodmaybepresent,especiallyin theearoronthescalpandbestpracticesdictatethatforsafety,abarrierbetweenthe practitioner’shandsandtheopenareaofskinisbesttoreducethelikelihoodoftransferof pathogensfromthepatienttothepractitionerorviceversa. Dealing with Blood to Blood Contact Acupuncturepractitionersandofficepersonnelareatriskforexposuretobloodborne pathogens,includinghepatitisBvirus(HBV),hepatitisCvirus(HCV),andhuman immunodeficiencyvirus(HIV).Exposuresoccurthroughneedlesticksorcutsfromothersharp instrumentscontaminatedwithaninfectedpatient'sbloodorthroughcontactoftheeye,nose, mouth,orskinwithapatient'sblood.Thevastmajorityofbloodtobloodcontactsresulting fromAOMproceduresdonotresultininfection.Ofthebloodbornepathogens,HBVisthemost likelytobepassedbyneedlestickexposure.HBVinfectionisusuallypreventablethrougha vaccineseries.However,theonlysuremethodofpreventingHIVandHCVisabstinencefrom activitiesthatinvolvetheexchangeofpotentiallyinfectedbodyfluids.Inthehealthcare workplace,accidentalcontactwithpotentiallycontaminatedbloodorbodyfluidsmaybe unavoidable.However,strictobservanceofStandardPrecautionscanpreventsinfectionfrom exposure,includingbloodbornepathogenssuchasHBV,HCV,andHIV.(16) Managing Used Needles Usedinstrumentsthathavepenetratedtheskinmustbeisolatedimmediatelyinanappropriate sharpscontainer.Usedneedles,lancetsandtheheadofasevenstar/plumblossomhammer shouldnotbereused,orsterilizedforreuse.Usedneedlespresentriskforpractitioners,staff, andchildrenwaitingfortheirparents. 80 Whenusingneedlesfrompackagesthatcontainmorethanoneneedle,allneedlesleftoverat theendofatreatmentmustalsobetreatedasnon-sterilesharpsandmustthereforealsobe discardedinanappropriatesharpscontainer.Theseunusedbutunsterileneedlesshouldnotbe setasideforuselaterinthedayonadifferentpatientorforuseonthesamepatientona differentday.Theyshouldbetreatedascontaminatedsharps. Asharpscontainerfortheusedneedlesshouldberightbesidethetreatmenttable,onaflat, stablesurface(notdirectlyonthetreatmenttable)sothatthereisnodelayinplacingused sharpsinthecontainerandawayfrompotentialaccidentalcontact.Alternatively,sharps containerscanbesecurelyfastenedtoawallclosetothetreatmenttable.Sharpscontainers shouldbeofofficialconstructionandlabeledwiththebiohazardsymbol. Sharpscontainersshouldbereplacedregularlyandnotbefilledabovethefillmarkorfilledin suchawaythatusedneedlesarestickingoutofthetop.Replaceacontainerwhenitisthreequartersfull;donotattempttopushdownthecontentssothatmoremaybeplacedinside. Thisiscriticalforstaffaswellaspractitioners,asstudiesdocumentthatasignificant percentageofstaffexperienceneedlestickswhilecleaningupsharpscontainers.(17) Counting Needles Onewaytoensurethatneedlesarenotleftinapatientorleftontreatmenttablesorfloors wheretheymaycauseaneedlestickinjurytoofficepersonnelistocountthenumberof needlesusedduringatreatmentandthencountthenumberofneedlesremovedanddiscarded afteratreatmentiscompleted.Theseneedlecountscanbedocumentedinthepatient’schart. Attheendofatreatment,ifoneormoreneedlesarenotlocatedduringneedleremoval,the practitionershouldcheckthetreatmenttableandflooraroundthetableforneedlesthatmay havefallenoutduringthetreatmentsession. 81 3. CNT in an Office Setting First,uponenteringtheroomwithapatient,washorcleanhands.Thenproceedwithclinical intakeandpulse/tonguediagnosis.Washhandsagainasneededpriortopalpatinganyareas forpainorlesions. Treatment Protocol in an Office Setting 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The selectedlocationCANNOTbethetreatmenttableasthepatientmaymovehisorher body!)[critical] 2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap. Liquidsoapisrecommendedratherthanbarsoap,whichmaybecomecontaminated. Or,ifsoapandwaterareunavailable,cleanhandswiththealcohol-basedhandsanitizer. [critical] 3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasaclean fieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthe surfacethatwillserveasthecleanfield.[stronglyrecommended] 4. Setoutthematerialsneededforatreatment.Sterileitemssuchasacupunctureneedles inblisterpacks(intheiroriginalpackaging)shouldbeplacedonthecenteroftheclean fieldfirst.Itisacceptabletoutilizeeitherindividuallywrappedneedlesorneedlesin multi-packsaslongastheyaresterile,single-useneedles.[recommended] 5. Cleanitemssuchascottonballsandunopenedswabsmayeitherbeplacedontheclean fieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandforthe practitioner.[recommended] 6. Ensuretheskinattheacupuncturepointstobeusedisclean.If70%alcoholswabsare used,allowthealcoholtodry.[stronglyrecommended] 7. Ifapractitionermustplacetheneedleinsideaguidetube,theneedleshouldbe droppedintothetube,handlefirst,tominimizetheriskofcontaminatingthepointof theneedle.[stronglyrecommended] 8. Insert,manipulate,andwithdrawtheneedlewithouttouchingtheshaftoftheneedle thatentersthepatient’sskinatanytime.[critical]Ifaguidetubeistobereused,it shouldbeplacedonthecleanfieldbetweenuses.[stronglyrecommended] 9. Iftheneedleislongorthinandcannotbeinsertedwithouttouchingtheshaft,the practitionershouldusesterilegauzeorcottontoholdtheshaftoftheneedleduring needleinsertionandmanipulation.[stronglyrecommended]Theneedleshaftshould neverbetouchedwiththebarehand,evenifthathandhasbeencleaned. 10. Ifthepractitionermissesthepointonthefirstinsertionandhastore-needle,anew needlemustbeused.Practitionersmaynotreinsertaneedlebecauseonceaneedlehas beeninserted,itisnolongersterileandmustbedisposedof.[critical] 82 11. Countthenumberofneedlesused,includingthosediscardedduetoimproperneedle placement.[stronglyrecommended] 12. Retainneedlesandstimulateasneededfortherapeuticeffect. 13. Removeneedles,puttingusedneedlesimmediatelyintoanappropriatesharps container.[critical] 14. Ifthepractitionerwishestocovertheskinwhereaneedlehasbeenremoved,aclean, drycottonballshouldbeused.[stronglyrecommended]Thecottonballneednotbe sterile. 15. Countthenumberofneedleswithdrawnfromthepatient.Confirmthatthesame numberofneedlesinsertedhasbeenwithdrawnanddiscarded.[strongly recommended] 16. Disposeofallcottonballsandalcoholswabsastheyareused,placingthemimmediately inanappropriatetrashcontainer.Theyarenottobeplacedonthecleanfieldafteruse. [critical] 17. Wash/cleansehandsbeforeleavingthetreatmentroom.[stronglyrecommended] 83 4. CNT for House Calls/Travel Setting Travel Kit /Travel Kit Carrier Thetravelkitshouldbecarriedinanappropriatehard-sidedcontainerorplasticcaselarge enoughtocarryalltherecommendedequipment.Thekitmustbehard-sidedinsideandoutso thatallsurfacescanbethoroughlycleaned.Itmusthaveatightclosure.Plasticbagsorsoftsidedcontainersarenotacceptablebecausetheyarenotpuncture-proof.(Examplesof acceptablecontainerswouldincludeafishingtacklebox,toolbox,amake-uporartbox,ora plasticcraftsupplybox.Anexampleofanunacceptablecasewouldincludealeatherbriefcase withaflaptopthatleavesagapatthesides.)Thecontainertobeusedmustbeableto accommodateasharpscontainerinanuprightpositionsoastolimitneedlelossfromthe sharpscontainer. Clean Items Thefollowingitemsshouldbeplacedinsideagallon-sizeziplockplasticbag.Notethatsomeof theseitemswillbeplacedinsidetheirownsmallerbag(i.e.,cottonballsandpapertowels)and thattheseitemsmustremainintheirownbagwhentheyareplacedinsidethelargerbag. • • • • • • Sealedpackagesofsterile,disposablesingle-useacupunctureneedlesofthelengthand gaugerequiredbythepractitioner.(Itisrecommendedthattravelkitscontainatleast 20needles;forpurposesoftheCNTcourse,CCAOMrequiresthatparticipantsbringat leasttwenty1inchandtwenty1.5inchneedlestotheCNTpracticalexam.) Commerciallypreparedcleanfields,cleanpapertoweling,oranyothercleansurface (suchasatray).Thiswillserveasacleanfieldandmustbepackedinitsownziplock plasticbagorcontainer. Clean,drycottonballs(atleast20)packedintheirownziplockplasticbag.Cottonballs neednotbesterile. Fivecommerciallysealedindividual2x2inchgauzepads.Thesewillbeusedtoholdthe shaftoftheneedleifsupportisneededuponinsertion. Onepairofglovesinacommercially-sealedpacketorinitsownplasticziplockbag.Thin glovesusedformedicalexaminationorsurgeryaresoldinmostdrugstoresandare bestsuitedfortravelkits.(Keepinmindthatsomepeopleareallergictolatex.)These glovesareusedincaseofemergencies.Forexample,theglovesmaybeneededtoclean upaccidentalspillsofcontaminatedneedlesorwaste.Theymayalsobeusedaccording toOSHAguidelinessuchaswhenbloodislikelytobepresentduringatreatment(e.g., bleedingtechniques). 70%isopropylalcoholpreppadsincommerciallysealedpackets(atleast30). 84 Non-Clean Items Thefollowingtwoitemsinthekitarekeptintwoseparategallon-sizedziplockplasticbags insidethetravelcontainersoastokeepthemseparatefromthecleanequipment: • • Asmallpaperbagwithaplasticlinertoreceivetrash(usedcottonballs,etc.).Thisbag shouldbeclearlymarkedininkas“Waste”or“Trash.” Asmall,red,commercialsharpscontainer.Thiscontainermustbeimpervious, unbreakable,clearlymarked"Contaminated,"andbeartheofficialbiohazardsymbol. Thesecontainerscanbepurchasedinamedicalsupplystoreorfromanacupuncture supplycompany.(Note:anythingthatqualifiesasmedicalwaste,suchasblood-soaked cottonballswouldneedtoberemovedbyamedicalwastedisposalfirmandwould thereforeneedtobediscardedinthesharpscontainerfortravelkituseonly.OSHA definescottonballssoakedwithbloodthatcanbewrungoutasbeingmedicalwaste; lessbloodthanthatshouldbeconsideredtrashandshouldbeplacedinthetrashbag. (17,18,19) Afteruse,theseitemsshouldbereplacedintheirindividualgallon-sizedziplockbags.These bagsshouldthenbesecurelysealedandplacedinsidethetravelcontainer. Travel Kit Items Not in Bags • • Hemostatortweezers(usedtoremovebrokenorstuckneedlesortopickupneedles fromthefloorifdropped). Alcohol-basedhandsanitizer PhotobyDarleneEaston andMorrisHoughton. 85 Hand Cleanser Abottleofalcohol-basedhandsanitizershouldalsobeincludedinthetravelkit.Thisshouldnot beplacedineitherthecleanitemsbagorthebagsforthenon-cleanitems,butshouldbe placedindependentlyinsidethetravelcarrier.Suchcleansershavebeenfoundtobeeffective inreducingcontaminationonthepractitioner’shandsifsoapandwaterarenotreadily availableatthetreatmentsite. Travel Sharps Container Eachstatehasdifferentrulesregardingsharpscontainersforuseathomeandforusein medicaloffices.Manystatesrequiretheuseofcommerciallypreparedsharpscontainersfor medicalpersonnel.Contactyourlocalhealthdepartmentorseethewebsite http://www.safeneedledisposal.org/forinformationbystateregardingsharpsdisposal regulations.InALLstates,useofacommerciallypreparedsharpscontainerwillmeetthe regulationsforsharpsdisposal.Ifanon-commercialcontainerislegalforuse(suchasapill bottlewithascrew-oncap),besuretomarkthecontainerwiththebiohazardsymboland disposeofthecontainerfollowingallrulesforbiohazardouswaste. Preparing the Kit Thekitshouldbepreparedinsuchawaythatallitemsinitremainclean. 1. Thehard-sidedcontainermustbewashedinsideandoutinhot,soapywateranddried withacleanpapertowel.Ziplockbagsshouldbefreshfromthepackageandfreeofrips andholes. 2. Handsshouldbewashedbeforeassemblingthekit. 3. Papertowelingshouldbetakendirectlyfromitspackageandplacedinasmallziplock plasticbagtoensurecontinuedcleanliness.Acommerciallyavailablecleanfieldwill comeindividuallywrapped. 4. Cottonballsshouldbetakendirectlyfromthestockbagandplacedinasmallplasticbag orothercontainer. 5. Pre-packagedalcoholswabsshouldbetakendirectlyfromtheiroriginalboxandplaced inthekit.Iftheindividualpackageshavebeensittingonashelf,theoutersurfacesof thepacketsarenolongerconsideredclean. 6. Disposableneedlesshouldbeplacedintothetravelkitdirectlyfromtheoriginalbox. Treatment Protocol in a Travel Setting 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.Ifnecessary, cleanitwithsoapandwateranddryitthoroughly.[recommended] 2. Openthetravelkitandremovethealcohol-basedhandsanitizer.Setitupnearwhere thecleanfieldwillbeplaced,sothatitiseasilyaccessible. 86 3. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap. Liquidsoapisrecommendedratherthanbarsoap,whichmaybecomecontaminated. Or,ifsoapandwaterareunavailable,disinfecthandswiththealcohol-basedhand sanitizerthatshouldbeincludedinthetravelkit.[critical] 4. Removethecleanpapertowelthatwillserveasacleanfield.Placeitontheclean,dry worksurfaceinawaythatdoesnotcompromisethecleanlinessofthesurfacethatwill serveasthecleanfield.[stronglyrecommended]Forexample,acleanfoldedtowel shouldbehandledbythefourcornersinordernottocontaminatethecenterofthe field.Ifalcoholisspilledorwetcottonisdroppedonapreviouslycleanfield,itcanno longerbeconsideredcleansincecontaminantscanwickintothefield.Anewcleanfield mustbeestablishedbeforeproceeding. 5. Setoutthematerialsfromthetravelkit.Sterileitemssuchasacupunctureneedlesin blisterpacks(intheiroriginalpackaging)shouldbeplacedonthecenteroftheclean fieldfirst.[stronglyrecommended]Cleanitemssuchascottonballsandunopened swabsshouldbeplacedonthecleanfieldneartheedgesofthefield.Thewastebagand theopenedsharpscontainershouldbeplacedlast,outsidethecleanfield,insuchaway thatyouwillnotneedtocrossthecleanfieldtodiscardausedneedleorwaste. [recommended] 6. Ensuretheskinattheacupuncturepointstobeusedisclean.If70%alcoholswabsare used,allowthealcoholtodry.[stronglyrecommended] 7. Ifapractitionermustplacetheneedleinsideaguidetube,theneedleshouldbe droppedintothetube,handlefirst,tominimizetheriskofcontaminatingthepointof theneedle.[stronglyrecommended] 8. Insert,manipulate,andwithdrawtheneedlewithouttouchingtheshaftoftheneedle thatentersthepatient’sskinatanytime.[critical]Ifaguidetubeistobereused,it shouldbeplacedonthecleanfieldbetweenuses,sinceithasbeenhandledandisno longersterile.[stronglyrecommended] 9. Ifthepractitionermissesthepointonthefirstinsertionandhastore-needle,anew needlemustbeused.[critical]Practitionersmaynotreinsertaneedlebecauseoncea needlehasbeeninserted,itisnolongersterileandmustbedisposedof. 10. Countthenumberofneedlesused,includingthosediscardedduetoimproperneedle placement.[stronglyrecommended] 11. Retainneedlesandstimulateasneededfortherapeuticeffect. 12. Removeneedles,puttingusedneedlesimmediatelyintoanappropriatesharps container.[critical] 13. Ifthepractitionerwishestocovertheskinwhereaneedlehasbeenremoved,aclean, drycottonballshouldbeused.[stronglyrecommended]Thecottonballneednotbe sterile.Awetcottonballorswabcanwickupbloodorotherpotentialinfectious 87 material,bringingitintocontactwiththepractitioner’sfingersandincreasingtheriskof cross-infection. 14. Countthenumberofneedleswithdrawnfromthepatient.Confirmthatthesame numberofneedlesinsertedhasbeenwithdrawnanddiscarded.[strongly recommended] 15. Disposeofallcottonballsandanyalcoholswabsastheyareused,placingthem immediatelyintheplastic-linedpaperwastebagcarriedforthatpurpose.Theyarenot tobeplacedonthecleanfieldafteruseandarenottobesetdownanywhereelsebut inthewastebag.Closethewastebagsecurelyafterthelastusedmaterialsareplaced inside. 16. Closethelidofthesharpscontainersecurelywhenyouaredonewiththetreatment. [critical] 17. Washhandsimmediatelyafterremovingneedlesandbeforehandlinganythingelse. [stronglyrecommended] 18. Packequipmentcorrectly,placingthesharpscontainerandwastebagintotheir separateziplockbagasthelaststepinpackingthekit. 19. Washhandssincethesharpscontainerandwastebagwerethelastitemshandled. [stronglyrecommended] Itisimportanttokeepinmindthatfundamentally,thereisnodifferencebetweenclean protocolintheofficeandinatravelsituation.Thebiomedicalrequirementsforsafetyarethe same. 88 5. CNT in a Community Acupuncture Clinic or NADA Setting TheCleanNeedleprotocolisessentiallythesameforeveryacupuncturepatientinanysetting. Thecriticalitemsremainthesame:alwaysestablishacleanfield,alwayswashhandsbefore everyacupuncturetreatment,alwaysusesingle-usedisposablesterilefiliformneedles,follow StandardPrecautions,andalwaysimmediatelyisolateusedsharpsinappropriatecontainers.In acommunityacupuncturesettingorNADAtreatmentsetting,multiplepatientsmaybetreated atthesametimeinthesameroomwhilesittinginchairs.Whiletheremaynotbeaspecific typeofchairthatisbestforthissetting,thepractitionerneedstoconsiderthatallchair surfacesneedtobecleanedbetweenpatientvisits;useofclothchairsmakesthismoredifficult. Additionally,ifasheetortablepaperisusedasabarrieronthetreatmentchairs,theseneedto bechangedforeachnewpatient.Armrestsorothersurfacesthatareexposedtobareskin duringtreatmentsshouldbecleanedbetweeneachpatientsession.Notethatifcareisnot takentoaccountforallneedlesusedinthesesetting,seatcushionshidemanyfallenneedles. Thosepersonscleaningtreatmentsurfacesmustbeassuredthatallneedlesareaccountedfor beforecleaningtreatmentchairs. Treatment Protocol in a Community Clinic or NADA Setting 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The selectedlocationCANNOTbethetreatmenttable!)Forcommunityacupunctureor NADA,aninstrumenttray,instrumentcartoratableinacentrallocationisappropriate. Ifdesired,asmallbasinorcontainerforusedmaterials(cottonballs,alcoholswabsand guidetubes)maybeplacedonthesametraynearthecleanfield.Thiscontainershould nottouchthecleanfield.[stronglyrecommended] 2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap. Liquidsoapisrecommendedratherthanbarsoap,whichmaybecomecontaminated. Or,ifsoapandwaterareunavailable,cleanhandswiththealcohol-basedhandsanitizer. [critical] 3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasaclean fieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthe surfacethatwillserveasthecleanfield.[stronglyrecommended] 4. Setoutthematerialsneededforallthetreatmentstobeperformedinasinglesession. Sterileitemssuchasacupunctureneedlesinblisterpacksshouldbeplacedonthe centerofthecleanfieldfirst.[stronglyrecommended]Cottonballs,gauze,andother materialsshouldbeplacedclosertotheedgesofthefield.[recommended] 5. Cleanitemssuchascottonballsandunopenedswabsmayeitherbeplacedontheclean fieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandforthe practitioner.[recommended] 89 6. Ensuretheskinattheacupuncturepointstobeusedisclean.If70%alcoholswabsare used,allowthealcoholtodry.[stronglyrecommended] 7. Ifapractitionermustplacetheneedleinsideaguidetube,theneedleshouldbe droppedintothetube,handlefirst,tominimizetheriskofcontaminatingthepointof theneedle.[stronglyrecommended] 8. Inserttheneedleswithouttouchingtheshaftoftheneedlethatwillbeinsertedintothe patient’sskin.[critical]Ifaguidetubeistobereused,itshouldbeplacedontheclean fieldbetweenuses,sinceithasbeenhandledandisnolongersterile.[strongly recommended] 9. Ifthepractitionermissesthepointonthefirstinsertionandhastore-needle,anew needlemustbeused.[critical]Practitionersmaynotreinsertaneedlebecauseoncea needlehasbeeninserted;itisnolongersterileandmustbedisposedof.[strongly recommended] 10. Usehandcleanserbetweeneachpatienttreatment.[stronglyrecommended] 11. Ensuretheskinattheacupuncturepointstobeusedisclean.[critical] 12. Repeatsteps8-11foreachpatientbeingtreatedduringasinglesession. 13. Removeneedlesfromthepatientoneatatime,puttingusedneedlesimmediatelyinto anappropriatesharpscontainer.[critical] 14. Ifthepractitionerwishestocovertheskinwhereaneedlehasbeenremoved,aclean, drycottonballshouldbeused.Thecottonballneednotbesterile.[strongly recommended] 15. Disposeofallcottonballsandalcoholswabsastheyareused,placingthemimmediately inacontaineronthetreatmentcartorinanappropriatetrashcontainer.Theyarenot tobeplacedonthecleanfieldafteruse.[recommended] 16. Wash/cleansehandsbeforeleavingthetreatmentroom.[stronglyrecommended] 90 6. CNT in a Public Health Setting Thereisagrowinguseofacupunctureinpublichealthsettingssuchasaddictiontreatment facilities,clinicsthattreatlargenumbersofHBV,HCV,andHIVpatients,andclinicswithhigh populationsofpatientsatriskofTB,aswellasininstitutionssuchasjails,publichospitals, communitycenters,andothersocialagenciesthathavegrouptreatmentroomswhereseveral patientssitandreceiveearorbodyacupuncture. Patientsmayarrivetogetherorseparately,butusuallydonothaveindividualappointments. Manyoftheseroomsdonothaveasink.Somemayhaveaccesstoonenearby,butitisnot alwaysguaranteed.Manyofthesesettingsaimattreatingpersonswhoaredrug-and/or alcohol-addictedandwhopresentwithrelatedandfrequentlymultiplehealthandsocial problemssuchasTB,HIVinfection,mentalillness,homelessness,hungerormalnutrition,or poverty.Theseindividualsfrequentlypresentwithalonghistoryofillnessandadebilitated immunesystem.Staffperformingacupuncturetreatmentsareappropriatelytrained acupuncturistsand/oracupuncturechemicaldependencyspecialists,dependingonstate regulations.Thereareoftenotherprovidersfromdifferentdisciplinesinvolvedsuchas physicians,socialworkers,nurses,counselors,communityworkers,physicianassistants,and nursepractitioners.Thecharacteristicsoftheseclinicsmandatesomespecialdiscussion. Handwashing Handwashingisoneofthemostproblematictopicswithinapublichealthorgrouptreatment setting.Itisnotrealistictoexpectthatthepractitionerwillwashhisorherhandsinasinkafter eachtreatmentduetothevolumeofpatientstobetreated,thetimeandlogisticsthatwould berequired,andfrequently,thelackoffacilitiesforhandwashing.Itiscritical,however,that practitionersutilizealcohol-basedhandsanitizersordisinfectingwipesbetweeneachpatient treatment.ItisalsostronglyrecommendedbyCDCthatpractitioners: 1. Washhandswithsoapandwateronarrivalandbeforeleavingwork,beforeeating,and afterrestroomuse.[critical] 2. Ifhandsaredirtywithsomeorganicmattersuchasblood,theymustbewashedwith runningwaterandsoap.[critical] 3. Analcohol-basedhandsanitizershouldbeusedbetweentreatments,providedthatonly theneedles,sterilepackages,andothermaterialsneededforthetreatmentwere touched.[stronglyrecommended] 4. Handsmustbecleansedbetweenpatienttreatments.[critical] 5. Analcohol-basedhandsanitizerorhandwipecanbeutilizedasneededduring treatmentsandbetweenpatienttreatments.[recommended] 91 6. Glovesshouldbeavailableinthetreatmentareaandshouldbewornwhenthereisan openwoundonthepractitioner’shandorthereisriskofbloodorOPIMcontamination, suchassignificantbleedingfromanauricularacupuncturepoint.[critical] 7. Practitionersshouldwashtheirhandsimmediatelywithsoapandwateraftercritical instances,suchascontactwithbloodorabreakinthecleanfieldbetweenorduring treatments.[critical](20) 8. Practitionersmusthaveappropriatehandcleansersavailabletothematalltimesinthe publichealthtreatmentenvironment.[critical] Acupuncture Equipment Disposableneedlesarerecommendedforallacupuncturetreatments.Somestatesmandate thatonlydisposableneedlescanbeutilizedbypractitioners,includingthoseworkinginpublic healthfacilitiestreatingchemicaldependency.Guidetubesarenotrecommendedforauricular acupuncture.Asalways,careshouldbetakentomonitorpressneedlesforpotentialinfections. Positioning the Patient Whenthepatientissittingup,itisimportanttomakesurethat,wherepossible,thepatienthas hisorherheadandnecksupported,thatthelegsandarmsarenotcrossed,andthattheperson iscomfortablyseated.Patientsshouldbeencouragedtousethebathroompriortotreatment. Ifapatientdoesneedtousetherestroomduringtreatment,allneedlesshouldberemoved andthenreplacedwhenheorshereturns. Removing Needles Whenapractitionerisremovingneedles,itiscriticalforasharpscontainertobeinthe immediatevicinity,preferablywherethecontainerissecureandcannotbeknockedover.In manypublichealthsettingsitisimportantthatneedlesbeaccountedforbycountingthe needlesused.Insettingssuchasjails,thepatientsoftenmaynotleaveuntilallneedlesare accountedfor.Insomedetoxclinicspatientsremovetheirownneedles.Intheseinstancesthe practitionershouldalwayscheckforneedlesthatmayhavedroppedandforbleedingthatmay haveoccurred.Inallcases,practitionersshouldcheckchairsandsurroundingareasforfallen needlesbefore,during,andaftereachsession,andaftereachpatient’sneedlesareremoved.If aneedlefallsoutoftheearontotheclothingofthepatientduringtreatment,itshouldbe removedwithaminimumofdisturbance.Practitionersshouldinstructpatientsnottohandle needlesiftheneedlesfalloutorafterremovingthemasthismaycreateasituationinwhicha needlestickinjurymayoccur.Itisalsocriticalthatpractitionersbeabletoidentifythenumber ofneedlesusedandthenumberproperlydiscardedinapublichealthsetting. 92 Potential Complications Ifapatientfaintswhilesittingup,allneedlesshouldberemovedimmediately,legselevated andtheheadlowered.Itisalsorecommendedthatpatientsbeplacedsafelyonthefloorif possible,makingsurethattheairwaysarenotobstructed.Acupuncturistsmayuseafingerto pressDu26(Renzhong)tohelprevivethepatient;callingformedicalhelpmaybenecessaryin somecases. Delayedbleedingiscommon.Practitionersmustbeawareofthispossibility.Patientsshouldbe monitoredafterneedleremovalandbeforeleavingthepremises. 93 7. Toyohari Acupuncture Contactneedling(ornon-insertionneedling)issometimesutilizedinJapanesemeridiantherapy andhasbeendevelopedindepthinToyohariacupuncture.Inthisstyleofacupuncture,“The needledoesnotpenetrateintothebody;theneedletipisheldattheskinsurfaceorperhaps touchestheskinbutdoesnotpenetratetheskin.”(21)Whenperformingcontactneedling,the needlemaybeplacedbetweenthecleanthumbandindexfingerofthenon-dominanthand, whicharerestingontheskinattheacupuncturepoint.Thisiscalledthe“oshide”inJapanese meridiantherapy.(22)Sincetheshaftoftheneedleisnotpenetratingtheskin,theneedleshaft doesnothavetobeprotectedassterile.However,thepractitioner’shands,andespeciallythe fingers,mustbeclean.Handwashingmusttakeplaceimmediatelybeforecontactneedlingas withneedlingwithinsertion.Whenpractitionersperformthistechnique,thethumbandindex fingerofthenon-dominanthandmustbeonthepatient’sskinandtheneedleisheldbetween thefingersbecausethechangesintheqiatthetipoftheneedlemustbefelttodothis techniqueproperly.(22,23) Modifications to Standard Clean Needle Technique for Contact Needling Thestandardsofhandwashing,settingupacleanfield,immediatelyisolatingusedsharpsand followingStandardPrecautionsremainthesameaswithallacupunctureneedlingtechniques. Thevariationhereisthattheshaftoftheneedlemaybetouchedbythepractitioner’sfingersin thisstyle. InToyohariacupuncture,theneedleitselfdoesnotpenetratetheskin.Therefore,when performingcontactneedling,theneedleremovalcanbefollowedwithplacingacleanfingeron thespotwheretheneedlehadbeenincontactwiththeskin,sincethereisnochanceofblood orOPIMbeingpresentwhenusingthistechnique.(21) 94 8. Summary of Safety Recommendations for Clean Needle Technique • • • • • • • • • • • • • • • • • • Critical:FollowCleanNeedleTechnique. Critical:Alwaysestablishacleanfieldbeforestartingacupunctureoranytechnique whichbreakstheskin. Critical:Onlyusesingle-usesterileinstrumentswhenbreakingtheskinsurface(needles andlancets). Critical:Alwayswashhandsimmediatelypriortostartingacupunctureoranytechnique whichbreakstheskin. Critical:Donottouchthetiporshaftoftheacupunctureneedlethatwillenterthe patient’sskinpriortoorduringneedleinsertionwithanythingwhichisnotitselfsterile. Critical:Donotneedleintoanyskinlesion.Acupunctureneedlesshouldneverbe insertedthroughinflamedorbrokenskin. Critical:Immediatelyisolateusedneedlesinanappropriatesharpscontainer. Critical:Usenewtablepaperoneachtreatmenttableforeachnewpatientvisit. Critical:Wipedowneachtreatmentchairortablewithanapproveddisinfectant solutionordisinfectantclothbetweeneachpatientvisit. Critical:Wearglovesorfingercots,orotherwisecoverupanyareasofbrokenskinon thepractitioner’shands. Critical:Checkneedlespriortouseforsterilizationexpirationdates,breaksinthe packaging,oranyevidencethatairorwaterhasenteredtheneedlepackagingpriorto use. Critical:Maintaincleanprocedureatalltimeswhilehandlingneedlespriortoinsertion. Ifneedlesortubesbecomecontaminated,theyshouldbediscarded. Critical:Needlemanipulationmustbeperformedwithoutthepractitionercominginto contactwiththepartoftheshaftoftheneedlethatwillenterthepatient’sskin. Critical:Neverinsertaneedleallthewaytothehandle. Critical:Whenusingamulti-needlepackofsterilizedneedles,oncethepackagingis openedforonepatientvisit,anyunusedneedlesmustbediscardedproperlyandnot savedforanotherpatienttreatmentsession. Critical:Allpatientsneedtobetreatedasiftheyarecarriersofbloodbornepathogens suchasHepatitisBorHIV. Critical:Ensurethatthepartofthebodytobetreatedisclean. Critical:Obtainamedicalhistoryfromapatientregardinglungfunction,lungdiseases andsmokinghistorybeforeneedlingthethorax.Assessthephysiqueofthepatient. Atrophyorpoormuscledevelopmentinthethoraxmayincreasetheriskof pneumothorax. 95 • • • • • • • • • • • • • • • • • • • Critical:Identifythoseacupuncturepointswhichlieoverornexttomajorvessels. Critical:Ifalcoholisusedtocleantheacupuncturesites,allowalcoholtodrybefore needling. StronglyRecommended:Countandwritedownthenumberofneedlesused,including thosediscardedduetoimproperneedleplacement.Countthenumberofneedles withdrawnfromthepatient.Confirmthatthesamenumberofneedlesinsertedhas beenwithdrawnanddiscarded. StronglyRecommended:Documentneedlecountsinthepatientchart. StronglyRecommended:Ensurethatthepatient’sskiniscleanbeforeinsertinganeedle orlancet.Skincanbecleanedwith70%isopropylalcoholorsoapandwaterorother method;if70%alcoholisused,allowalcoholtodrybeforeneedling. StronglyRecommended:Useonlysingle-usesterilefiliformneedlesforacupuncture treatments. StronglyRecommended:Whenneedlestabilizationisneeded,thepractitionershould usesterilecottonorsterilegauzetostabilizetheshaftoftheneedle. StronglyRecommended:Palpatesubcutaneousstructures,includingmajorvessels, beforepreparinganacupuncturesiteforneedleinsertion. StronglyRecommended:Identifytheproperdepthofneedleinsertionandutilizeproper stimulationtechniquesforneedlesplacedbelowthesubcutaneouslevel. StronglyRecommended:Angleacupunctureneedlesobliquelywheninsertingneedles fromthetopoftheshoulderstotheT-10areaontheback,ortobelowthexiphoidlevel onthechest. StronglyRecommended:Limitthedepthofacupunctureneedleinsertiontothe subcutaneouslayerandinitialperimysiumoftheintercostalmuscles. StronglyRecommended:Neverinsertaneedletothehandle. StronglyRecommended:Allpatienthistoriesshouldincludeinformationaboutcurrent orpastdiseasesthatmightleadtoachangeinthesizeoftheorgans. StronglyRecommended:Iftherearesignsthatanorganmayhavebeenpunctured, emergencytransportshouldbecalledtotakethepatienttoanemergencyfacility. StronglyRecommended:WashhandsoruseCDC-approvedhandcleanseruponentering apatientroomandaftercompletinganypatienttreatment. StronglyRecommended:Guidetubesmustbesterileatthebeginningofthetreatment andmustnotbeusedformorethanonepatient. StronglyRecommended:Establishanewcleanfieldforeachnewpatient. StronglyRecommended:Replaceanyclothtablecoveringsaftereachpatientvisit. StronglyRecommended:Utilizegloveswhenremovingneedlesfromlocationswhere bleedingislikely. 96 • • • • • • • • • • • • • • • • StronglyRecommended:Afterneedleremoval,applypressuretotheacupuncturepoint withcleancottonorgauze. StronglyRecommended:Cleanalltreatmentroomsurfaceswithapproveddisinfectants daily. StronglyRecommended:Ifyoustickyourselfwithausedorcontaminatedneedle,seek medicaladviceimmediately. Recommended:Cleanallcommonuseareaswithanapproveddisinfectantdaily. Recommended:Practitionersshouldremovealljewelryandartificialnailspriorto handwashing. Recommended:Explainacupunctureproceduresindetailandanswerallpatient questionsabouttheprocedurestobeperformedpriortoacupuncturetoallayconcerns andnervousness.Makesurethepatientisawareofthelikelyeffectsofacupuncture. Recommended:Informpatientsthattheyshouldeat1-2hourspriortoacupuncture treatments. Recommended:Whileitisacceptabletopalpatethecleanedareaofskintoprecisely locatetheacupuncturepointaftertheskiniscleanedandbeforeneedling,the practitionershouldnottracefingersorhandsacrossawideareaofskintolocatean acupuncturepointaftertheskiniscleanedandbeforeneedling. Recommended:Palpatesubcutaneousstructures,includingbloodvessels,tendons, musclesandbones,beforepreparingthesiteforinsertion. Recommended:Limitneedlemanipulationduringthefirstacupuncturetreatmentor untilclinicalassessmentofthepatient’sresponsetoacupuncturehasbeenestablished. Recommended:Remindpatientstoremainstillduringacupuncturetreatments. Recommended:Needlemanipulationshouldbelimitedorbi-directionalwhentwirlingis involvedasindicatedbydesiredtherapeuticeffecttolimitthelikelihoodofastuck needle. Recommended:Ifaneedleisstuckwhenattemptingremoval,try(1)twistingtheneedle intheoppositedirectionfromtheinitialstimulation;(2)stimulatingthemeridiannear thestuckneedlewithsimplefingerpressure;(3)tappingnearthestuckneedle;(4) insertinganotherneedlenearbythestickneedle;or(5)waitafewminutesthentryto removetheneedleagain. Recommended:Afterneedlewithdrawal,applypressuretotheacupuncturepointwith cleancottonorgauze. Recommended:Havethesamepractitionerremovetheneedlesastheonewho insertedtheneedlesforbettermemorycuesaboutpossiblehiddenneedlesites. Recommended:Keepused/emptyneedlepacketsinthetreatmentroomuntiltheend ofthepatient’streatment;confirmallneedlesremovedfromthepackagingare 97 • • accountedforeitherbyremovalfromthepatient,discardedunused,ordiscardedafter contamination. Recommended:Ifunexpectedaggravationofsymptomsoccursasaresultof acupuncturetreatment,considerconsultationwithorreferraltoanotherpractitioner forfurtherevaluationpriortoperformingadditionalacupuncturetreatments. Recommended:Investigateandfollowlocalandstateregulationconcerningskin preparation. References 1.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages Press,Beijing;1987. 2.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress, Seattle,WA.1981. 3.CentersforDiseaseControlandPrevention.ShowMetheScience-WhentoUseHand SanitizerinHandwashing:CleanHandsSave Liveshttp://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html. ReviewedOctober17;2014.AccessedJanuary3,2014. 4.CentersforDiseaseControlandPrevention.When&HowtoWashYourHandsin Handwashing:CleanHandsSaveLives.http://www.cdc.gov/handwashing/when-howhandwashing.html.ReviewedOctober17,2014.AccessedJanuary3,2014. 5.WorldHealthOrganization.WHObestpracticesforinjectionsandrelatedprocedurestoolkit. http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf.PublishedMarch 2010.AccessedDecember2012. 6.KhawajaR,SikandarR,QureshiR,JarenoR.RoutineSkinPreparationwith70%Isopropyl AlcoholSwab:IsitNecessarybeforeanInjection?QuasiStudy.JLiaquatUMedHealth Sciences(JLUMHS).2013;12(2)(May-Aug):109-14. 7.DannTC.Routineskinpreparationbeforeinjection:anunnecessaryprocedure.Lancet1969; 2:96-7 8.KoivistoJA,FeligP.Isskinpreparationnecessarybeforeinsulininjection?Lancet1978;1: 1072-1073 9.McCarthyJA,CovarrubisB,SinkP.Isthetraditionalalcoholwipenecessarybeforeaninsulin injection?DiabetesCare1993;16(1);402 10.NationalInstitutesofHealth.PatientEducation:Givingasubcutaneousinjection. http://www.cc.nih.gov/ccc/patient_education/pepubs/subq.pdf.Published6/2012. AccessedSeptember2013. 11.CentersforDiseaseControlandPrevention,HealthcareInfectionControlPracticesAdvisory Committee(HICPAC).2007GuidelineforIsolationPrecautions:PreventingTransmission ofInfectiousAgentsinHealthcareSettings.PartIII:PrecautionstoPreventTransmission 98 ofInfectiousAgents.http://www.cdc.gov/hicpac/2007ip/2007ip_part3.html.Reviewed December29,2009.AccessedNovember2012. 12.WorldHealthOrganization.Minimizinginfectionthroughimprovedinfectioncontrol. http://www.who.int/patientsafety/education/curriculum/who_mc_topic-9.pdf.WHO GlobalPatientSafetyChallenge:CleanCareisSaferCareandtheHôpitauxUniversitaires deGenève.AccessedNovember2012. 13.LinJ-G,ChouP-C,ChuH-Y.AnExplorationoftheNeedlingDepthinAcupuncture:TheSafe NeedlingDepthandTheNeedlingDepthofClinicalEfficacy.Evidence-BasedComplAlt Med.2013;2013:21. 14.Deadman,P.,Al-Khafaji,M.AManualofAcupuncture.JournalofChineseMedicine Publications;2001 15.PeukerE,GronemeyerD.Rarebutseriouscomplicationsofacupuncture:traumaticlesions. AcupunctMed.2001;19(2):103-108. 16.CentersforDiseaseControlandPrevention.CDCExposuretoBlood,WhatHealthcare PersonnelNeedtoKnow.http://www.cdc.gov/HAI/pdfs/bbp/Exp_to_Blood.pdf. UpdatedJuly2003.AccessedDecember2012. 17.CentersforDiseaseControlandPrevention,NationalInstituteforOccupationalSafetyand Health.Selecting,EvaluatingandUsingSharpsDisposalContainers. www.cdc.gov/niosh/docs/97-111/pdfs/97-111.pdf.PublishedJanuary1998.Accessed April2013. 18.OccupationalSafetyandHealthStandards.1910.1030Bloodbornepathogens. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p _id=10051.AccessedDecember2012. 19.CentersforDiseaseControlandPrevention,HealthcareInfectionControlPracticesAdvisory Committee(HICPAC).Guidelinesforenvironmentalinfectioncontrolinhealth-care facilities:recommendationsofCDCandtheHealthcareInfectionControlPractices AdvisoryCommittee(HICPAC). http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf.Published2003. AccessedDecember2012. 20.CentersforDiseaseControlandPrevention.HandHygieneBasicsinHandHygienein HealthcareSettings.http://www.cdc.gov/handhygiene/Basics.html.ReviewedMay1, 2014.AccessedJanuary2015. 21.Birch,S.TraditionalNeedlingTechniquesasPracticalConstructionsfromReadingHistorical Descriptions.TheEuropeanJournalofOrientalMedicine;20137(3)p27. 22.Denmai,Shudo.EffectivePointLocation:FindingActiveAcupuncturePoints.2003,Seattle: EastlandPress. 99 23.Birch,S.GraspingtheSleepingTiger’sTail:PerspectivesonAcupuncturefromtheEdgeof theAbyss.NorthAmericanJournalofOrientalMedicine.2004,November11(32)pp.2023. 100 Part III: Best Practices for Related AOM Office Procedures Inthehealthcarefield,bestpracticesareproceduresthatcouldbefollowedtolimitdangersto thepatients,practitionerandstaff.Bestpracticescanberevisedasneededtokeepupwiththe latestresearch.Bestpracticeguidelinesproducedspecificallyforpracticinghealthprofessionals arebasedonthebestavailableresearchevidenceasreportedinsystematicreviews,case reports,referencetexts,andothersourcesofevidence. ThefollowingrecommendationsutilizepracticesasdescribedinChineseAcupunctureand Moxibustion(1)andAcupuncture–AComprehensiveText,(2)andapplysafetypracticesbased ontheevidencefromPartIofthismanualtoAOMclinicalpracticeprocedures.Thebest practiceguidelinesbelowoutlinecriticalproceduresandofferoptionsforrecommended procedures. ThereareanumberofothermethodswithsafetyprotocolsapplicabletovariousstylesofAOM officeprocedures.Thissectionisnotmeanttobeexhaustiveorprohibitive,butrathertobe instructive.Schoolsandpractitionersareencouragedtoimplementadditionalandalternative methodstoreducerisk,utilizingadditionalandalternativetechniquesformoxaandother practicesutilizingAOMclinicaltraditions. AsnotedinPartI,unlikeacupunctureneedling,manyoftheseprocedureshavereceivedfar lessscrutinyinthemedicalliterature.Fewprospectiveorretrospectivestudieshavebeen conductedtoenumeratethesafetyissuesassociatedwithAOMclinicalpracticesotherthan needling.Thebestpracticesnotedhereinhavebeendesignedbasedontheliteratureavailable, traditionalAOMtrainingorhavebeenadaptedfrommedicalpracticesutilizingsimilar processes. Eachofthefollowingrecommendationsisonlyoneversionofbestpracticesthatcouldbe utilizedwhereinapractitionerappliesthecriticalandstronglyrecommendedcautionstoeach AOMpractice.Thesearenotmeanttoidentifystandardpracticesforanyofthesetechniques. Practitionersneedtodeterminetheirownmethodologiestoimplementclinicalbestpractices giventheinformationavailableinthismanual,themedicalandAOMliterature,andother sourcesofinformationthatapplytotheirspecificstyleofpractice. Forthepurposesofthismanual,thefollowingtermswillbeutilizedtohelppractitionersapply bestpracticestotheirpersonalpractices:critical,stronglyrecommendedandrecommended. Seetheintroductionforanexplanationoftheseterms. 101 1. Moxibustion Moxibustion Overview Moxibustionistheburningofmugwort(Artemesiavulgaris)herb(moxa)onorneartheskin, withorwithoutacupunctureneedlesforthepurposeofwarmingtissuesinordertostimulate circulationofqiandblood,transformfluids,orwarmtheyang.Moxamayalsobeusedto resolveheattoxinsanddriveheatoutward,nourishyin,descendtheqi,andtootherwise balancethemeridians,substancesandzang-fudependinguponthelocationandtypeof moxibustionperformed.Theeffectivenessofmoxibustionhasbeenshowninawiderangeof conditionsfrommusculoskeletaldisorders,gynecologicconditions,anddigestivecomplaintsto thetreatmentofHerpeszosterandotherinfections. Moxibustionmayoccasionallycauseburningandblisteringoftheskin(firstorseconddegree burns).Patientsmustalwaysbeaskedforconsentbeforeapractitionerappliesmoxibustion techniques. Practitionersperformingmoxibustionshouldavoidcausingunnecessaryburns(seescarring moxabelowfortheexceptiontothisrule)andbeawarethateachpersonhasadifferent tolerancetoheat.Itisimportanttobeespeciallycarefulwithpersonswhohaveconditions wheresensitivityoflocalnervesmaybediminished,suchasinneuralinjury,diabetesmellitus, orpathologyresultinginparalysis,becausesuchpersonsareespeciallysusceptibletoburns. EvenchemicalheatdevicessuchasHotSpotsandheatlampshavebeenknowntoburn diabeticpatients. Whenusingindirectmoxaontheneedle,besuretoprotectthepatient’sskinfromanyfalling moxaorashes.Ifusingdirectmoxa,itissuggestedthatthepractitionerfullyexplainthe techniquetothepatientandaskthepatienttosignaninformed,writtenconsentformbefore usingthistechnique. Ifapatienthasbeenburned,infectionistheprimaryconcern.Iftheburnisaverysmallfirst degreeburn,currentpracticeistoruncoolwaterovertheburn(neverice),andthenapply sterilegauze.(Ifthisisnotpossible,useanover-the-counterburncreamfollowedbythe applicationofsterilegauze.)Ifaburnissevere,orifthereisaconcernwithinfection,referthe patienttoaphysician. Therisksofexposuretomoxasmokeareprobablysimilartothatforanyothersmoke,andtotal exposuretime,particularlywhenitinvolvesprolongedexposure,isthekeyconcern.Occasional useofordinarymoxawouldbeassociatedwithlowrisk,whileroutineexposuretomoxasmoke duringmuchofthedaywouldbeamoderaterisk.Therefore,usingaspaceinwhichthereis 102 properventilation(ortheuseofaHEPAfilter)isappropriatewhenmoxibustionisbeing performed. Theriskofsettingafireduringmoxatherapiesissmallbutpossible.Allnecessaryfiresafety protocolsshouldbefollowed.Itisstronglyrecommendedthatroomsinwhichmoxa treatmentsaretobeperformedbeequippedwitheitherfireextinguishersorsprinklersystems. Watershouldbepresentandavailabletoextinguishsmallburnsontreatmentsurfacesor patientsduringallmoxatherapies.Practitionersshouldnotwalkfromroomtoroomwithlit moxamaterials.Instead,moxashouldbelitascloseaspossibletothetreatmenttableorchair andextinguishedassoonastreatmentisconcluded.Lightingofmoxashouldbedonewithout anopenflamecomingclosetothepatient’shair,skinorclothing.Inthemethodsdiscussed below,anincensestickisusedtolightthemoxa;othermethodsforlightingthemoxawithout utilizinganopenflamecanbeutilizedbasedonpractitionerpreference. General Moxibustion Precautions • • • • • • • • • • • • Critical:Practitionersmustwashhandsthoroughlybeforestartingmoxibustion,and beforeandaftertreatinganyburnsasOPIMmaybepresent. Critical:Preventseconddegreeburnsfrommoxabypayingcloseattentiontoapatient’s comfortandskinreactionsduringalltreatments. Critical:Takeacarefulpatienthistorytoidentifyneuropathiesorotherconditionsthat mightlimitapatient’sresponsetopainortheabilitytosenseheat. Critical:Duringmoxatherapythepractitionermustremainintheroomatalltimes. Critical:Anticipateandshieldapatient’sskinfromfallingashwhenutilizingneedle-top moxa. Critical:Avoidmoxibustiononthefaceorinthehairline. Critical:Roomsinwhichmoxibustionisbeingperformedmusthaveproperventilation. StronglyRecommended:Thepractitionershouldnotattempttomulti-taskduringthe applicationofmoxatherapies. StronglyRecommended:Thepractitionershouldmonitortheskintemperatureand amountofheatgeneratedbymoxaandnotrelysolelyonpatientfeedbackaboutheat sensationswhenutilizinganyformofmoxibustion. StronglyRecommended:Measureandchartthediameterandlocationofanyburns occurringasaresultofmoxatherapies. StronglyRecommended:PractitionersutilizeairfilterunitswhichincludeHEPAfilters whenperformingmoxibustion. Recommended:Roomsinwhichmoxaistobeusedshouldbeequippedwithwaterand afireextinguisher. 103 • Recommended:Consideroptionsotherthanmoxaforpatientswithahistoryof significantasthmaorotherreactionstosmoke. Moxa Best Practice Guidelines Afterreviewingtheliteratureaboutmoxibustionsafetyandusingtheinformationaboutthe possibleAEsassociatedwithmoxatherapies,thefollowingbestpracticeguidelineshavebeen developed.Asstatedatthestartofthissectionofthemanual,theseproceduresaredesigned tolimitdangerstothepatients,practitionerandstaff.Inallcases,thefollowingprocedurescan berevisedasneededtokeepupwiththelatestresearchandmodifiedasneededforspecific stylesofpracticeaslongassafetyremainsthepriority. Direct Moxibustion - Technique for Non-Scarring Moxibustion with Moxa Cones Amoxaconeisplacedonapointandignited.Whenabout2/3ofitisburntorthepatientfeels aburningdiscomfort,themoxaisremoved. Method 1. Athoroughpatienthistoryisperformedtoidentifyanyconditionsthatbeingperformed thatmightlimitapatient’sresponsetopainortheabilitytosenseheat[critical]ormay increaseareactiontothemoxasmoke.[recommended] 2. Properventilationisassuredthroughuseofwindowsorairfiltersorotherairfiltering process.[critical] 3. Moxaconesarepreparedpriortolightinganymoxa. 4. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable Equipment:moxacones,tweezers/hemostat(ifdesired),cupofwater(ifdesired), ashtray(ifdesired),lubricantorskinlotion,lighter,incensestick,andotherequipment asneeded. 5. Thepractitionerwasheshisorherhands.[critical] 6. Theareatowhichmoxawillbeappliedispreparedwithskinlotionorlubricant,if desired,basedonthetypeofmoxapractice. 7. Thefirstconeofmoxa,unlit,isappliedtotheskinlocation. 8. Amaterialsuchasanincensestickislighted,usingthelighter,awayfromthepatient. Othermaterialscanbeusedaslongasanopenflameiskeptsomedistancefromthe patient’sskin.[recommended] 9. Ifdesired,ahemostatortweezersmaybeappliedtothemoxaandtheincense(orother material)isthenusedtolightthemoxa.[recommended]Practitionersmayalsochoose tousetheirfingersformoxaapplicationandwithdrawalbasedonpersonalpreference andtraining. 10. Thepractitionermonitorstheskintemperatureandamountofheatgeneratedbythe moxacone.[stronglyrecommended] 104 11. Whenabout2/3ofthemoxaisburntorthepatientfeelsaburningdiscomfort,remove theconeandplacethemoxainthecupofwaterorashtray;thissteppreventsthe patient’sskinfrombeingburnedandpreventsthestill-burningmoxafromburningthe practitioner,patient,orfurnitureandkeepsburningashoutofthetrash. [recommended] 12. Usefingersorthehemostats/tweezerstoplacethenextconeontheskinandrepeatas necessary. Singleormultipleconesarecontinuouslyburnttocauseanincreaseinbloodflow/flushatthe localsite,butnoblistershouldbeformed. Safety Considerations 1. Alwayshaveaccesstowaterto: a. Beabletosnuffanyburningashthatfalls. b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately. c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernon-flammable receptacleispreferred. 2. Neverleaveapatientalonewhenmoxaisbeingapplied. 3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion. 4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlookaway fromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatientduring moxibustionapplication. 5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.This preventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdropping burningmoxaontothepatientortreatmentsurface. 6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbeflushed downthesink.Donotputmoxaashdirectlyintoatrashcanasthismayigniteatrashfire. 7. Neverapplydirectmoxatothefaceorwithinthehairline. Direct Moxibustion - Technique for Scarring Moxibustion with Moxa Cones Amoxaconeisplacedonapointandignited.Inthismethod,themoxaisnotremoveduntil afterithasburneddowntotheendorablisterforms. Method 1. Athoroughpatienthistoryisperformedtoidentifyanyconditionsthatbeingperformed thatmightlimitapatient’sresponsetopainortheabilitytosenseheat[critical]ormay increaseareactiontothemoxasmoke.[recommended] 2. Properventilationisassuredthroughuseofwindowsorairfiltersorotherairfiltering process.[critical] 3. Moxaconesarepreparedpriortolightinganymoxa.[recommended] 105 4. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable Equipment:moxacones,hemostat/forceps/tweezers,cupofwater(ifdesired),ashtray (ifdesired),lubricantorskinlotion,lighter,incensestick,andotherequipmentas needed.[recommended] 5. Thepractitionerwasheshisorherhands.[critical] 6. Theareatowhichmoxawillbeappliedispreparedwithskinlotionorlubricant,if desired,basedonthetypeofmoxapractice. 7. Thefirstconeofmoxa,unlit,isappliedtotheskinatthepointorlocationchosenbythe practitioner.[recommended] 8. Amaterialsuchasanincensestickislighted,usingthelighter,awayfromthepatient. Othermaterialscanbeusedaslongasanopenflameiskeptsomedistancefromthe patient’sskin.[recommended] 9. Ifdesired,ahemostatortweezersmaybeappliedtothemoxaandtheincense(orother material)isthenusedtolightthemoxa.[recommended]Practitionersmayalsochoose tousetheirfingersformoxaapplicationandwithdrawalbasedonpersonalpreference andtraining. 10. Thepractitionermonitorstheskintemperatureandamountofheatgeneratedbythe moxacone.[stronglyrecommended] 11. Whentheconeofmoxahasburneddown,orthereisavisibleblister,removethecone andplacethemoxainthecupofwaterorashtray. 12. Usefingersorthehemostats/tweezerstoplacethenextconeontheskinandrepeatas necessarytoachievethedesiredeffect. 13. Onceasmallblisterhasformed,theburnmustbetreatedproperly:Cooltheburnwith coldrunningwateruntilthepainisrelieved;applysterilegauzeandusesurgicaltapeto keepthegauzeinplace;alternately,acommerciallypreparedbandagemaybeusedto covertheburnedarea.[critical] Asmanyasthreeormoreconesofmoxaarecontinuouslyburnttocausetheformationofa smallblister.Thismethodisveryinfrequentlyusedexceptforsevereconditions. Safety Considerations 1. Alwayshaveaccesstowaterto: a. Beabletosnuffanyburningashthatfalls. b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately. c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernonflammablereceptacleispreferred. 2. Neverleaveapatientalonewhenmoxaisbeingapplied. 3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion. 106 4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlook awayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatient duringmoxibustionapplication. 5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.This preventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdropping burningmoxaontothepatientortreatmentsurface. 6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbe flusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayignitea trashfire. 7. Neverapplydirectmoxatothefaceorwithinthehairline. Indirect Moxibustion – Technique with Interposed Moxibustion Theignitedmoxaconedoesnotcontacttheskindirectly,butisinsulatedfromtheskinbya layerofginger,salt,garlic,oraconitecake.Dependingonthetechniqueused,thiskindofmoxa mayinduceblistering,butitismostfrequentlyusedfornon-scarringmoxibustion. Method 1. Asinglemoxaconeispreparedpriortouse. 2. Athoroughpatienthistoryisperformedtoidentifyanyconditionsthatmightlimita patient’sresponsetopainortheabilitytosenseheat[critical]ormayincreasea reactiontothemoxasmoke.[recommended] 3. Properventilationisassuredthroughuseofwindowsorairfiltersorotherairfiltering process.[critical] 4. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable. Equipment:moxacones,hemostat/forceps/tweezers,herbalinsulation(aconitecake, garlic,andginger),cupofwater(ifdesired),ashtray(ifdesired),lubricantorskinlotion, lighter,incensestick,andotherequipmentasneeded.[recommended] 5. Thepractitionerwasheshisorherhands.[critical] 6. Theareatowhichmoxawillbeappliedispreparedwithskinlotionorlubricant,if desiredbasedonthetypeofmoxapractice. 7. Theherbalinsulationisthenappliedtotheareatobeheated. 8. Theconeofmoxa,unlit,isappliedtotheherbalinsulator. 9. Ifdesired,ahemostatortweezersmaybeappliedtothemoxaandtheincense(orother material)isthenusedtolightthemoxa.[recommended]Practitionersmayalsochoose tousetheirfingersformoxaapplicationandwithdrawalbasedonpersonalpreference andtraining. 10. Amaterialsuchasanincensestickislighted,usingthelighter,awayfromthepatient. Othermaterialscanbeusedaslongasanopenflameiskeptsomedistancefromthe patient’sskin.[recommended] 107 11. Whenabout2/3ofthemoxaisburntorthepatientfeelsaburningdiscomfort,remove theconeandinsulatorandplacethemoxainthecupofwaterorashtray. [recommended] Safety Considerations 1. Alwayshaveaccesstowaterto: a. Beabletosnuffanyburningashthatfalls. b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately. c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernonflammablereceptacleispreferred. 2. Neverleaveapatientalonewhenmoxaisbeingapplied. 3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion. 4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlook awayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatient duringmoxibustionapplication. 5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.This preventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdropping burningmoxaontothepatientortreatmentsurface. 6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbe flusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayignitea trashfire. 7. Neverapplyinterposedmoxatothefaceorwithinthehairline. Indirect Moxibustion - Warming Needle Moxibustion Thismethodusesbothaneedleandmoxa.Aftertheacupuncturepointisneedledand stimulatedasdesiredorneededforthearrivalofqi,asmallsectionofamoxastick(about2cm long)oramoxaconeisplacedonthehandleoftheneedle.Themoxastickisthenignitedfrom itsbottomandallowedtoburnout. Themethodbelowusesnoadditionalmaterialtosecurethemoxaontheneedle.Instead,a protectivecoverofcardboardisplacedontheskintoavoidburningashesfromfallingonthe patient.Othermethodsanddeviceshavebeenutilizedsafelytopreventthemoxafromfalling onthepatient.Thespecificmethodordevicetobeusedcanbechosenbasedonsafety evidenceandpractitionerpreferences. Method 1. Moxasticksorconesarepreparedpriortolightinganymoxa. 2. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable. Equipment:moxasticksorloosemoxatomakecones,tweezers/forceps/hemostat,cup 108 ofwater(ifdesired),ashtray(ifdesired),protectiveskincover,lighter,andincensestick. [recommended] 3. Thepractitionerwasheshisorherhands.[critical] 4. AcleanneedletrayispreparedasdiscussedintheCNTsectionofthismanual.[critical] 5. TheacupunctureisperformedfollowingCNTguidelines.[critical] 6. Insertmetal-onlyneedlestothedepthrequiredtoretaintheneedleuprightsecurely. Donotuseplastictippedneedlesastheplasticmaymeltduringthemoxatherapy. [recommended] 7. Adiscofinsulatorcardboardorothermaterialisplacedonthepatient’sskinaroundthe baseoftheneedle.Alternately,adeviceorinsulatormaterialisattachedtotheneedle belowwherethemoxawillsit.Bothmethodspreventashfromfallingonthepatient’s skin.[stronglyrecommended] 8. Asmallstickorconeofmoxaisplacedonthehandleoftheneedle. 9. Theincenseislighted,usingthelighter,awayfromthepatient.[recommended] 10. Theincenseisusedtolightthemoxa,whichhasbeenplacedonthehandleofthe needle.[recommended] 11. Whenabout2/3ofthemoxaisburntorthepatientfeelsawarmsensationaroundthe needle,removetheconeandplacethemoxainthecupofwaterorashtray. [recommended] 12. Shouldthepatientindicatethatthereisanuncomfortableamountofheat,usethe tweezersorhemostattoimmediatelyremovetheneedleandmoxa.Thehotneedle mustberemovedwithaninstrument,sinceitwillbetoohottomanipulatesafelyby hand.[recommended] Safety Considerations 1. Alwayshaveaccesstowaterto: a. Beabletosnuffanyburningashthatfalls. b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately. c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernon-flammable receptacleispreferred. 2. Neverleaveapatientalonewhenmoxaisbeingapplied. 3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion. 4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlook awayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatient duringmoxibustionapplication. 5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.This preventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdropping burningmoxaontothepatientortreatmentsurface. 109 6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbe flusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayignitea trashfire. 7. Neverapplywarmingneedlemoxatotheface. Indirect Moxa – Technique with Moxa Stick Moxasticksmaybeusedeither(1)byholdingthemoxa2-3cmoverthesitetobetreatedto bringmildwarmthtothearea/pointforupto15minutes,oruntiltheskinbecomesslightlyred orwarmtothepractitioner’stouch;or(2)theignitedmoxastickismovedupanddownover thepointornearoraroundanacupunctureneedle. Becausemoxastickscanbeverydifficulttobelitproperly,forpractitionersafety,itis recommendedthatacandle,orfireplaceflametorchbeused.Inthemethodbelow,acandleis used.Othermethodsthatkeeptheflameawayfromthepatientandthepractitioner’sfingers maybeutilizedbasedonpractitionerpreference. Method 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable. Equipment:moxastick,moxaextinguisher,cupofwater(ifdesired),lighter,andcandle. [recommended] 2. Thepractitionerwasheshisorherhands.[critical] 3. Lightthecandleusingthelighter.Thenlightthemoxastickusingthecandle. [recommended] 4. Immediatelyextinguishthecandleoncethemoxaislit.[recommended] 5. Applymoxausingoneofthemethodsabove. 6. Everyfewminutes,tapanyashfromthemoxastickintothemoxaextinguisherto preventfallingashfromfallingonthepatientorthetable.[stronglyrecommended] 7. Whenthepatientfeelswarmth,removethestickandapplytothenextpointtobe warmed,asneeded.[recommended] 8. Aftertherequisitepointshavebeenwarmedasindicatedforthetreatmentdesired, placethemoxastickintheextinguisher,litenddownward.[critical] 9. Usethecupofwater,ifnecessary,toextinguishashthatfallsoutsideofthemoxa extinguishertray.[recommended] Safety Considerations 1. Alwayshavewateronhandto: a. Beabletosnuffanyburningashthatfalls. b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately. 2. Neverleaveapatientalonewhenmoxaisbeingapplied. 110 3. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlook awayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatient duringmoxibustionapplication. 4. Tapmoxatoremoveashasneeded;avoidscrapingtheashfromthemoxastickasthis mayloosentheburningtipofmoxawhichthenmayfallonthepatientortreatment surface. 5. Oncethetreatmentiscomplete,moxashouldberetainedinthemoxaextinguisherfor atleastonehourtoensurethatthemoxaisfullyextinguished. 6. Themoxaintheextinguishercanberemovedfromtheextinguisherafter1hour,wet downinasinkandthenthrownawayinmetalcansorotherashreceptacles,butnotin theregulartrashtopreventtrashfires. Moxa Disposal Topreventburnsandfires,allmoxanotflusheddownasinkmustbeproperlydisposedofin metalorothercontainersspecificallydesignedforashes. 1. Makesureallusedmoxasticksarecontainedinanappropriateextinguisherfornoless than1hourafteruse. 2. Putallusedmoxaandmoxasticksthathavenotbeenflusheddownthesinkinametal bucketwithatightfittingmetallid,afterthe1hourextinguishingperiodiscomplete.An alternativeistouseametalsmokingreceptacledesignedforusedcigarettedisposal. 3. When¾full,themetalbucket(orreceptacle)canthenhaveitscoversecuredtightly andthebucketcanthenbedisposedofintheregulartrash. 111 2. Heat Lamps Best Practice Protocols for Heat Lamps Heatlampsaredesignedforuseinapplicationsspecificallyrequiringashort-waveinfrared radiationsource.Infraredradiationfromthislampcausessurfacestobeheated.Formostof thecommonlyusedcommercialheatlamps(suchasTDPlamps),lampsshouldneverbeplaced closerthan12inchestoanypersonorsurface.Someheatinglampsaredesignedformuch lowertemperaturesandmaybebroughtclosertothepatient’sskinsurfaceifthatcanbe accomplishedsafelyandaccordingtothemanufacturer’smanuals. Method Forusewhenheatingisneededoverageneralareafortherapeuticwarming. 1. Checklampforanydefects.[critical] 2. Checktheareatobetreatedforskinlesions.[stronglyrecommended] 3. Makesureallclothingandcombustiblematerialsaremovedsufficientlyoutofthearea tobeheated.[stronglyrecommended] 4. Pluglampintothewallsocket. 5. Positionlampheadatleast12inchesfromtheareatobeheated.[strongly recommended] 6. Turnontheheatlampthensettimefornomorethan10-15minutes.[recommended] 7. Becausetheheatofthelampmaycausetheheadoftheunittodroptowardthe patient,neverleavetheimmediateareaofapatientbeingtreatedwithaheatlamp. [stronglyrecommended] 8. Checktheareabeingheatedatleastonceevery5minutestobesurethattheskindoes notbecometoohotorthatthelamparmpositionhasnotchanged.[strongly recommended] 9. Unplugthelamponcetheheatingperiodhasended.[recommended] Safety Considerations • • • • • Critical:Heattherapiesmustbecloselymonitoredbypractitioners. Critical:Heatlampsshouldnotbeusedoninfants,children,incapacitated,sleeping,or unconsciouspersons. Critical:Whenheatlampsareusedonpatientswhohaveareducedresponsetoheat, theuseofheatmustbemonitoredatalltimes. Critical:Preventwater,moisture,liquidsormetalobjectsfromcomingincontactwith thelamp.Donotuseaheatlampinwetormoistenvironments. Critical:Donotuseifanypartofthelampiscracked.Donotallowanypartofthelamp totouchaccessoryequipment. 112 • • • • • • StronglyRecommended:Heatlampsshouldnotbeusedwithoutaresponsible attendantpresentduringtheentiredurationofuse. StronglyRecommended:Donotuseover-sensitiveskinorpersonshavingpoorblood circulation.Sufficienttemperaturesaregeneratedthatmaycauseburns. StronglyRecommended:Takeacarefulpatienthistorytoidentifydiabetes, neuropathies,orotherconditionsthatmightlimitapatient’sresponsetopainorthe abilitytosenseheat. StronglyRecommended:Thepractitionershouldmonitorthepatient’sskintemperature andtheamountofheatgeneratedbyaheatlampandnotrelysolelyonpatient feedbackaboutheatsensations. StronglyRecommended:Donotusethisheatsourceincloseproximitytocombustible materials(litter,paper,etc.)ortomaterialsadverselyaffectedbyheatordrying. Recommended:Whenapatient’sinformationisunclear,requestanopinionfroma physicianbeforeusingaheatlamponthelimbsofapatientwithdiabeticorother neuropathies. 113 3. Cupping Cupping Overview Cupping(baguanfad)isatherapeuticprocedureusedbyAOMandotherhealthcare practitionersaroundtheworld.Cupping,oneoftheoldestmethodsoftraditionalChinese medicine,isaccomplishedbyhavingacupappliedtotheskin;thepressureinthecupis reducedbyusingachangeinheatorbysuctioningoutair,sothattheskinandsuperficial musclelayerisdrawnintoandheldinthecup.Cuppingusesapartialvacuumtointentionally createtherapeuticpetechiaeandecchymosisinthedermis.Thereareanumberofcupping styles,includingsuctioncupping,firecupping,emptycupping,slidingorglidingcupping.Best practiceguidelinesareprovidedforthreeofthesestyles:firecupping,suctioncupping,andwet cuppingorcuppingaftertheuseofalancetforbloodwithdrawal. General Recommendations for Cupping • • • • • • • • • • • • • Critical:FollowStandardPrecautions. Critical:FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField. Critical:FollowSafetyGuidelinesforHandSanitation. Critical:Cuppingshouldnotbeapplied48hoursbeforeor24hoursafterchemotherapy treatment. Critical:Cupoverclearskinonly.Donotcupoveranactiveskinlesion,moles,swelling, trauma,inflammation,infection,orburns(includingsunburn). Critical:Practitionersmusttakeathoroughhistory,includingbleedingdisordersand medicationhistory,beforeapplyingcups. Critical:Practitionersmusttakeathoroughhistorytoidentifydiabetes,neuropathiesor otherconditionsthatmightlimitapatient’sresponsetopainwhenplanningtoutilize firecupping. Critical:Screenpatientsforhistoryofreactiveskinlesionssuchaskeloidscarringor Köebnerphenomenon. Critical:Assesscarefullytheuseoffirecuppingonpatientswhohaveadecreased responsetopain(e.g.,thosewithdiabetesorneuropathies). Critical:Practitionersmustwashhandsbeforestartingtheprocedureandagainafter removinggloves(ifused). Critical:Personalprotectiveequipment(PPE)-wearglovesandeyeprotectionatall timeswhenbloodorOPIMmaybepresent(wetcupping,cuppingafterneedling). Critical:Eachareatobewetcuppedmustbecleanedimmediatelybeforecuppingbythe practitioner. Critical:Lancetsusedforwetcuppingshouldbesterile,usedonlyonce,thendiscarded inapropersharpscontainer. 114 • • • • • • • • • • • • • • Critical:IfbloodorotherOPIMarepresent,collectwithcottonswab,gauze,paper towel,orclothanddisposeinbiohazardtrash. Critical:WhenbloodorotherOPIMarepresent,allowthevacuumtobecompromised slowly,andthenremovethecup. Critical:Iflubricantsareusedforglidingcuppingormovingcupping,decantaportionfor use.Donotdipbackintolubricantcontainerortouchthespoutofapumpcontainer whilecupping. Critical:UseappropriatePPEwhilecleaninganddisinfectingcups. Critical:Cleanallcupsofalllubricantsandbiologicalmaterialusingsoapandwater beforedisinfecting. Critical:DisinfectallcupsusinganappropriateFDA-clearedintermediate-tohigh-level disinfectingsolutioninaccordancewithlabelinstructions. StronglyRecommended:Usecautionifcuppingpatientscurrentlytakinganti-coagulant medications. StronglyRecommended:Cuppingoverneedlesmaycauseneedlestotravelbeyonda safedepth.Eitherinserttheneedleobliquely,oravoidthetherapyinareaswith underlyingorgans. StronglyRecommended:Placeburningmaterialintothedeepestpartofcup,andnever retaintheburningmaterialinsidethecupswhenthecupsareplacedontotheskin. StronglyRecommended:Observecarefulandlimitretentiontimetothephysical toleranceofthepatient. StronglyRecommended:Disinfectallcupsusingahigh-leveldisinfectingsolution followingpackagedirectionsforsemi-criticaldevices. StronglyRecommended:Explaintherapeuticintentionofcuppingandpresentatimeline ofresolution.Cupchildrenonlyinthepresenceofaparentorassignedguardian. Recommended:Usedisposablecupsforwetcuppinganddisposeofusedwetcupsin thebiohazardtrash. Recommended:Ahandoutexplainingcuppinginclinicalpractice,includingskinchanges andatimelinefortheirresolution,mayprotectthepatientfromthestressof misinterpretation. Sample Best Practice Protocols for Cupping Afterreviewingtheliteratureaboutcuppingsafety(PartIofthismanual),thesafety recommendationsabove,andusingtheinformationaboutthepossibleAEsassociatedwith cuppingtherapies,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthe startofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients, practitionersandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeep upwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongas safetyremainsthepriority. 115 Fire Cupping Method Thisprocedureinvolvestheuseofanopenflamenearapatient.Thismay,ifthetechniqueis notdonesmoothly,occasionallycauseburningandblisteringoftheskin(firstorseconddegree burn).Inaddition,thecuppingmayleaveredorbruise-likecircularmarkswherethecupsare applied.Thepatientshouldbeeducatedthatthesemarksarecommonplacewiththis technique.Thepatientshouldalsobeinformedthattheyshouldkeepthecuppedarea protectedfromwindorcolddrafts.Itisstronglyrecommendedthatpatientsbeaskedfor consentbeforeapplyingcuppingtechniques. 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable. Equipment:cuppingjar,hemostat,lighter,cottonball,alcohol,andburncream. [recommended] 2. Thepractitionerwasheshisorherhands.[critical] 3. Iftheareatowhichcuppingwillbeappliedneedstobecleaned,cleaningcanbe accomplishedwithalcohol,soapandwater,oranothercleansingtechnique[critical] 4. Theflameapparatusispreparedbyclampingacottonballinthehemostatandthen slightlymoisteningthecottonwithalcohol.Alternately,analcoholswabmaybeused. 5. Thejarisheldwiththemouthfacingperpendicularlytotheskinsurfaceinthenondominanthand.[stronglyrecommended] 6. Theflameapparatusislitandtheninonesinglemotion: a. Theflameisintroduceddeepintothecupquicklyandpulledawayatthesame timethatthecupisthenappliedtotheskinsurface[critical] b. Thehemostatisremovedobliquelyawayfromthepatient’sskinsurfaceinorder toensuresafety.[stronglyrecommended] c. Theflameisextinguished.[critical] d. Oncetheflamehasbeenextinguishedandtheflameapparatusremovedtothe equipmentsurface,thepractitionerwilldeterminethelevelofsuctioninduced andwillretainthecupfor2-10minutesormoreorrepeattheaboveprocedure tocreateastrongervacuum. 7. Thecupisremovedwhenthetherapyisdonebygentlypryingthejaredgeupfromthe skinordepressingtheskinnexttotherimofthecuptodefeatthevacuum.Thecupis thenputasideandprocessedforcleaninganddisinfecting.[stronglyrecommended] Safety Considerations • • Aliveflameisutilizedandsoallproperprecautionsasindicatedelsewhereinthis manualmustbefollowed,includingsettingupequipmentonaworksurfacethatisnot flammablenear,butnoton,thetreatmenttable.[critical] Theworkspacemustbekeptclearofobstructions.[stronglyrecommended] 116 • • • • Haveaccesstowatertoputouttheflameifnecessaryortocooltheskinifasmallburn doesoccur.[recommended] Payverycloseattentiontothepatientduringthecupapplication.[strongly recommended] Haveafireextinguisheronhandinaroominwhichyouareusingfire-throwingcupping. [recommended] Inordertopreventskininjury,checktherimofeachcupbeforeuseandmakesurethat thereisnobrokenorcrackedarea.[critical] Suction Cupping Cuppingmayleaveredorbruise-likecircularmarkswherethecupsareapplied.Thepatient shouldbeeducatedthatthesemarksarecommonplacewiththistechnique.Thepatientshould alsobeinformedthatheorsheshouldkeepthecuppedareaprotectedfromwindorcold drafts.Itisstronglyrecommendedthatpatientsbeaskedforconsentbeforeapplyingcupping techniques. Asthismethodusesnoflame,burnsarenotanadverseeventassociatedwiththismethodof cupping. Method 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable. Equipment:cuppingjars,pumpextractor,lubricant.[recommended] 2. Thepractitionerwasheshisorherhands.[critical] 3. Iftheareatowhichcuppingwillbeappliedneedstobecleaned,usealcohol,soapand water,oranothercleansingtechnique.[stronglyrecommended] 4. Asmallamountoflotionorlubricantisappliedtotheskin.[recommended] 5. Placethecupontheskin,attachthepumpextractor,andremoveenoughairtobring someskinintothecup. 6. Thecupisremovedwhenthetherapyisdonebyreleasingthesuctionvalvetodefeat thevacuum.Thecupisthenputasideandprocessedforcleaninganddisinfecting. [recommended] Wet Cupping Thismethodinvolvesbothblood-lettingandcupping.Bestpracticesforbothpartsofthis treatmentareincorporatedbelow. 117 Method 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable. Equipment:cuppingjars,lubricant,andacleanfieldwithlancets,cottonballs,alcohol swabs,sterilegauze,sharpscontainer,andskincleanser.[recommended] 2. Thepractitionerwasheshisorherhands.[critical] 3. Practitionersmustuseglovesandshouldalsoutilizeeyeprotectiontopreventexposure toblood.[critical] 4. Theareatowhichcuppingwillbeappliediscleanedwithalcohol(ormaybethoroughly cleanedwithappropriatematerialssuchassoapandwater).[critical] 5. Theskinatthesiteshouldbepuncturedusingsterilelancets,withanewlancetbeing usedforeachpuncture.[critical]Discardthelancetsdirectlyintothesharpscontainer afteruse.[critical] 6. Applythecups(pumporflamecuppingasdescribedabove)andretainforthedesired lengthoftherapy. 7. Ifthepractitionerhasremovedeitherglovesorgoggles,putthepersonalprotective equipment(PPE)backonforcupremoval.[critical] 8. Allowthevacuumtobecompromisedslowlythenremovethecup,takingcareto preventbodyfluidfromspreadingorsplashing.[critical] 9. Immediatelyisolatethecups. 10. Stopanycontinuedbleedingthroughuseofappropriatepressureusingsterilegauze. [critical] 11. Cleanupanybleedingthathasoccurred.Cleanthesiteofthepunctureswithan appropriateskincleanser.[stronglyrecommended] 12. Discardextravasatedbloodinthebiohazardtrash.[critical] 13. Immediatelywashcupswithsoapandwater. 14. Removegoggles,gownandgloves.DisposeofPPEasindicatedbytheclinic’sOSHA standard. 15. Washhandswithsoapandwater.[critical] 16. Removecupstoprocessingareaforinstrumentdecontamination. 17. CleanthecupsofanybiologicalmaterialwithsoapandwaterandlubricantTHEN sterilizethecups.[critical]Or,discardcontaminatedcupsinthebiohazardtrash. [recommended] 18. Sterilizewithaautoclaveorbyfollowinglabelinstructionforhigh-leveldisinfection solution(forexample,immersefor6hoursin7.3%hydrogenperoxidesolution).[critical] 19. Cleanequipmentsurfaceandtablewithanappropriatedisinfectantsolution.[critical] 118 4. Therapeutic Blood Withdrawal Bleeding Overview InChineseAcupunctureandMoxibustion,(1)theuseofthethree-edgedneedle(lance)issaid tohavebeenhistoricallyusedforhighfever,mentaldisorders,sorethroat,andlocalcongestion orswelling.Modernpractitionersmayusebleedingtechniquestoclearheatsyndromes, stronglydispersepoints,andstronglystimulatespecificpoints.Astotechnique,thepointtobe bledisprickedsuperficially,just0.05-0.1cun(inches)deep,whichshouldbelightand superficialandtheamountofbleedingtobe"determinedbythepathologicalcondition."In general,acupuncturistsshouldusecautionifemployingbleedingtherapyforpersonswhohave weaknessoftheiryinoryangqi,ableedingdisorder,aweakconstitution,orwhotake anticoagulantmedication. General Recommendations for Bleeding Techniques • • • • • • • • Critical:Personalprotectiveequipment(PPE)-wearglovesatalltimesasbloodand OPIMwillbepresent. Critical:Lancingdevicesmustbelimitedinusetoasinglepatient. Critical:Lancetsshouldbeusedonlyonce,andthendiscardedinapropersharps container. Critical:Lancetsshouldbeusedonlyonceandcannotbereinsertedintoanothersite onthesameoradifferentpatient. Critical:Practitionersmusttakeathoroughhistory,includingbleedingdisordersand medicationhistory,beforeusingbleedingtechniques. Critical:Donotbleedinanareaofanactiveskinlesion. Recommended:Utilizeeyeprotection,suchasgoggles,whenperformingbleeding techniques. Recommended:Utilizesingle-uselancetsengineeredtoretractafteruseto significantlyreducetheriskofneedlestickinjuries. Sample Best Practice Protocol for Bleeding Acupuncture Points Afterreviewingtheliteratureaboutbleedingsafety(inPartIofthismanual),thesafety recommendationsabove,andtheinformationaboutthepossibleAEsassociatedwithbleeding practices,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestartof thissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients, practitionersandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeep upwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongas safetyremainsthepriority. 119 Method 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The selectedlocationCANNOTbethetreatmenttable!)[stronglyrecommended] 2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap. Or,ifsoapandwaterareunavailable,cleanhandswithanalcohol-basedhandsanitizer. [critical] 3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasaclean fieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthe surfacethatwillserveasthecleanfield.[critical] 4. Setoutthematerialsneededforatreatment.Lancetsshouldbeplacedonthecenterof thecleanfieldfirst.[recommended] 5. Cleanitemssuchascottonballsandunopenedalcoholswabsmayeitherbeplacedon thecleanfieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandfor thepractitioner.[recommended] 6. Putongloves[critical]andgogglesorothereyeprotectionasindicatedbythesafety committeeorofficeratyourclinic.[recommended] 7. Ensurethatthepatient’sskiniscleanbeforeinsertingalancet.Skincanbecleanedwith 70%isopropylalcohol,soapandwater,oranothermethod.[critical]Ifusinganalcohol swab,allowthealcoholtodry.[critical] 8. Pulltheskintautneartheareatobelanced.[recommended] 9. Pressthelancetquicklyintothepoint.Somepractitionerspositionthelancetbevelside downoverandjustlateraltotheintendedpoint,thenrollthelancetoverandintothe pointinordertoavoidthediscomfortofasuddendeepneedlestick.Usearetractable single-uselancetifthemethodbeingusedallowsfortheuseofsuch.[recommended] Suchdevicestendtoproduceadeeperneedlestickandmaycausemorepatient discomfortbutmaylimitneedlestickrisk.However,retractabledevicesmustbeusedon asinglepatientanddiscarded. 10. Disposeofthelancetimmediatelyintoanappropriatesharpscontainer.[critical] 11. “Milk”or“squeeze”enoughbloodfromthelancedpointasindicatedfortheresultyou expect. 12. Useasterilecottonballorgauzetoremovebloodfromthelancedarea. [recommended] 13. Disposeofthecottonballinthebiohazardtrash.[stronglyrecommended] 14. Reexamineneedledsitesasecondtimeforsignsofbleedingorhematoma,andapply pressurewithasterilecottonballorgauzeifnecessary.[recommended] 15. Cleanthesiteofthelancedskinandcoverwithabandageasnecessaryifitisstill bleeding.[stronglyrecommended] 16. Removeglovesandgoggles.DisposeofPPEasindicatedbytheclinic’sOSHAstandard. 120 17. Washhandsimmediatelyaftercompletingtheprocedureandremovinggloves.[critical] 121 5. Plum Blossom/Seven Star Needle Plum Blossom Overview Plumblossom/sevenstarneedles(orcutaneousacupuncture)isdescribedinAcupuncture:A ComprehensiveText(2)asbeingusefultotreatthecutaneouschannelsandinternaldiseases associatedwiththemeridianoverwhichtheskinwillbetapped.Sevenstarneedlingisusedin AOMpracticesforthetreatmentofavarietyofpainsyndromes. General Recommendations for Plum Blossom • • • • • • • • • • • • Critical:FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField. Critical:FollowSafetyGuidelinesforHandSanitation. Critical:FollowSafetyGuidelinesforSkinPreparation. Critical:PPEisrequired–wearglovesatalltimesasbloodandOPIMwillbepresent. Critical:Theareatobetreatedmustbecleanandfreeofanyskinlesionsortraumatic injury. Critical:Theareaofpatient’sskintobetreatedmustbecleanpriortotreatment. Critical:Theheadoftheplumblossomdevicemustbesterile.Donottouchthetipsof theneedles. Critical:Useonlysingle-usesterileplumblossomneedles. Critical:Usedplumblossomneedlesmustbediscardedintoapropersharpscontainer immediatelyafteruse. StronglyRecommended:Avoidbringingthehandholdingthehammeruptoohighor tappingtooforcefullysoastopreventpuncturingtheskin. StronglyRecommended:Avoidflingingthehammeraroundsoastopreventthespread ofbloodorOPIM. Recommended:Practitionersshouldwearglovesandeyeprotectionwhileusingthe plumblossomdevice. Best Practice Protocols for Plum Blossom Afterreviewingtheliteratureaboutplumblossomsafety(PartIofthismanual),thesafety recommendationsabove,andusingtheinformationaboutthepossibleAEsassociatedwith sevenstarneedlingpractices,thefollowingbestpracticeguidelineshavebeendeveloped.As statedatthestartofthissectionofthemanual,theseproceduresaredesignedtolimitdangers topatients,practitioners,andstaff.Inallcases,thefollowingprocedurescanberevisedas neededtokeepupwiththelatestresearchandmodifiedasneededforspecificstylesof practiceaslongassafetyremainsthepriority. 122 Method 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The selectedlocationCANNOTbethetreatmenttable!)[stronglyrecommended] 2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap. Or,ifsoapandwaterareunavailable,cleanhandswithanalcohol-basedhandsanitizer. [critical] 3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasaclean fieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthe surfacethatwillserveasthecleanfield.[recommended] 4. Setoutthematerialsneededforatreatment.Sevenstarhammersshouldbeplacedon thecenterofthecleanfieldfirst.[recommended] 5. Cleanitemssuchascottonballsandunopenedalcoholswabsmayeitherbeplacedon thecleanfieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandfor thepractitioner.[recommended] 6. Putongloves[critical]andgogglesorothereyeprotection.[recommended] 7. Ensurethatthepatient’sskiniscleanbeforeutilizingtheplumblossomneedle.[critical] Skincanbecleanedwith70%isopropylalcohol,soapandwater,oranothermethod.If usinganalcoholswab,allowthealcoholtodry.[critical] 8. Thesevenstarhammerisheld1-2inchesabovethesurfaceoftheskinandtapped rapidlyalongtheareatobestimulated.Avoidbringingthehandholdingthehammerup toohighortappingtooforcefullysoastopreventpuncturingtheskin.Avoidflingingthe hammeraroundsoastopreventspreadofbloodorOPIM.[recommended] 9. Whentheskinbecomesred,orproperreactionhasbeenobserved,stoputilizingthe plumblossomdevice.[recommended] 10. Disposeoftheplumblossomhammerimmediatelyintoanappropriatesharps container.[critical] 11. Cleanthesiteofthetreatmentandcoverwithabandageasnecessary(ifbleeding). [recommended] 12. Removeglovesandgoggles.DisposeofusedPPEasindicatedbytheclinic’sOSHA document. 13. Washhandsimmediatelyaftercompletingtheprocedureandremovinggloves.[critical] 123 6. Gua Sha Gua Sha Overview Guashaistheprocessofclosely-timedunidirectionalpress-strokingofthebodysurfacewitha smooth-edgedinstrumenttointentionallyraisetransitorytherapeuticpetechiaeand ecchymosisrepresentingextravasatedbloodinthesubcutis.Guashaisnotassociatedwith significantadverseeventsexceptmisinterpretationoftherapeuticpetechiaeasillness,injury, orabusebyotherpractitioners.Studywithaqualifiedguashainstructorisrecommendedto learnpreciselyhowandwheretoguashaandhowtouseguashainaclinicalpractice.(SeePart Ifortheliteraturereview.) Summary of Gua Sha Recommendations • • • • • • • • • • • • Critical:FollowStandardPrecautions. Critical:FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField. Critical:FollowSafetyGuidelinesforHandSanitation. Critical:Practitionersmusttakeathoroughpatienthistory,includingbleedingdisorders andmedicationhistory,beforeutilizingguashainordertoplanforanyexcessive petechiaeproduction. Critical:Guashashouldnotbeapplied48hoursbeforeor24hoursafterchemotherapy treatment. Critical:Ifreusableguashadevicesarebeingused,theymustbecleanedoflubricant andbiologicalmaterialandthendisinfectedusinganapprovedintermediate-orhigh- leveldisinfectingsolutionfollowingpackagedirectionsforreusablemedicaldevices. Critical:Lubricantsshouldbedispensedfromapumporsqueezebottletoprevent contaminatingthelubricantreserve.Donottouchthespoutofthepumporthenozzle ofthesqueezebottle. Critical:Guashashouldbeappliedtoclearskinonly.Donotapplytoactiverash,lesion, inflammation,infection,moles,swelling,trauma,burns(includingsunburn),orbreaksin theskinbarrier. Critical:UseappropriatePPEwhilecleaninganddisinfectingreusableguashatools. StronglyRecommended:Anyapplicationofguashaforchildrenshouldbedoneinthe presenceofaparentorguardian. StronglyRecommended:Disinfectallguashadevicesusingahigh-leveldisinfecting solution,followingpackagedirectionsforthedisinfectionofsemi-criticalreusable medicaldevices. Recommended:Immediatelypriortothepracticeofguasha,theexpectedresultof petechiaeshouldbeexplainedtothepatient. 124 • Recommended:Considerhavingahandoutexplainingexpectedguashaeffectsandskin changestogivetopatientsbeforeapplyingguasha. Gua Sha Best Practice Protocols Afterreviewingtheliteratureaboutguashasafety(PartIofthismanual),thesafety recommendationsabove,andusingtheinformationaboutthepossibleAEsassociatedwithgua shapractices,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestart ofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients, practitionersandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeep upwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongas safetyremainsthepriority. Itispossibletospreadirritationorinfectionfromoneareatoanotherwhenpracticingguasha. Itisalsopossibletocontaminatebothacontaineroflubricantusedformultiplepatientsand theguashatoolitself,andthenspreadthatcontaminationthroughtheuseofguashato multiplepatients.Therefore,themethodforbestpracticeinguashaisasfollows: Method 1. Prepareyourtools: a. Setaclean,disinfectedmulti-useguashatool(oracleandisposabletool)ona cleanfield.[recommended] b. Putasmallamountoflubricantinadisposablepapercup(usingatongue depressororanotherdisposabledevicesuchasaplasticknife),orsetasqueeze bottleoflubricantathandbutnotonthecleanfield.[stronglyrecommended] 2. Washyourhands.[critical] 3. Ensuretheareatobetreatedisfreeofcuts,inflammation,infection,swelling,trauma, burns,andactivelesionsthroughvisualinspection.[critical] 4. Reiteratethefactthatpetechiaewillberaisedandbruisingiscommon;getaverbal confirmationthatthepatientunderstandstheexpectedskindiscolorationfromthe treatment.[recommended] 5. Applyguashatoareatobetreated. 6. Discardanylubricantinthecup(ifused)andanydisposableguashatool(ifadisposable toolisused).[recommended] 7. Washhands.[critical] 8. Inspectthepatient’sskinagainforreactiontotheguashatreatment,remindhimorher tokeeptheareacoveredandwarm.[recommended] 9. Washanddisinfectanyreusableguashatools.[critical] 125 7. Acupoint Injection Therapies Thereareafewstatesinwhichacupuncturistsmayuseinjections(suchassaline,B-12orherbal extracts)tostimulateacupuncturesites.AccordingtoAcupuncture:AComprehensiveText,(2) theseinjectionsmaybegivenatfront(Mu)orback(Shu)points,or“pointsofpositive response.” Forthosepractitionerswhowishtoutilizeinjectiontherapiesandforwhomthescopeof practiceallowsinjections,thefollowingresourcesaresuggested: WHOBestPracticesforInjectionTherapiesandRelatedProceduresToolkit:(5) http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf CDC:http://www.cdc.gov/injectionsafety/CDCsRole.html(6) andhttp://www.oneandonlycampaign.org(7) AccordingtotheWHO:(5)“Methodsforreducingexposureandpreventinginfection transmissionincludehandhygiene,barrierprotection(gloves),minimalmanipulationofsharp instruments(includinginjectionequipment),andappropriatesegregationanddisposalof sharpswaste(note:sharpsareitemssuchasneedlesthathavecorners,edgesorprojections capableofcuttingorpiercingtheskin). Injectionsareunsafewhengivenwithunsterileorimproperequipmentortechnique.Itis importanttoavoidcontaminationofinjectablemedications.Physicallyseparatingcleanand contaminatedequipmentandsupplieshelpstopreventcross-contamination.Forexample, immediatedisposalofausedsyringeandneedleinasafetyboxplacedwithinarm’sreachisthe firststepinsafewastemanagement.” TheCDChaspublishedtheresultsoftheinvestigationoffourlargeoutbreaksofHBVandHCV amongpatientsinambulatorycarecentersandidentifiedthatnotonlyisproperinjection techniquerequired,butbasicprinciplesofaseptictechniquemustbeadheredtoforthe preparationofinjectionsyringes.(8)TheCDCrecommendstheuseofsingle-dosevialsof injectablemedicationinsteadofmultiple-dosevials.Wheremultipledosevialsareused,the useofaseparatepreparationworkarea,awayfromthepatienttreatmentroomisrequired. Thefollowingpracticesarestronglyrecommendedtoensurethesafetyofinjections: • • • • Properhandhygiene. Useofgloveswhereappropriate. Useofothersingle-usepersonalprotectiveequipment. Utilizationofasepticpracticesinsyringepreparation. 126 • • • Patientskinpreparationandskinpathogenreductiontechniques(useoftopical antiseptics). Theuseofsingle-usedisposablesterileinjectionequipment. Theimmediateisolationofusedsyringesinapropersharpscontainer. Risksofinjectiontherapiesaresimilartothoseofneedlingandincludepain,bruising,bleeding, infections,injurytoorgansandnervetissue,patientdizzinessorfainting.However,thereare additionalrisksofinfectionorskinreactionduetoinjectionofmaterialundertheskin.Itis criticalthatallmaterialtobeinjectedbemanufacturedspecificallyforthatpurposeandbe maintainedinasterilestatepriortouse. AccordingtotheCDC,“OnlywhenpatientsandprovidersbothinsistonOneNeedle,One Syringe,OnlyOneTimeforeachandeveryinjectionwilltheriskofcontractinginfectious diseasethroughinjectionsbeeliminated.”(7) Ingeneral,practitionersshouldusethesameCleanNeedleTechniqueset-upforinjections. Additionalprecautionsareneededforthesubstancestobeinjected.Thesesubstancesmustbe preparedforinjectionandremainsterilebeforeuse. Whenusingasterilesingle-usesyringeorhypodermicneedle: • • • Useanewdeviceforeachprocedure,includingforthereconstitutionofaunitof medication.[critical] Inspectthepackagingofthedevicetoensurethattheprotectivebarrierhasnotbeen breached.[critical] Discardthedeviceifthepackagehasbeenpunctured,tornordamagedbyexposureto water,orwhentheexpirationdatehaspassed.[critical] Acupoint Injection Therapy Best Practice Protocols 1. Keeptheinjectionpreparationareafreeofcluttersoallsurfacescanbeeasilycleaned. 2. Beforestartingtheinjectionsession,andwheneverthereiscontaminationwithblood orbodyfluids,cleanthepreparationsurfaceswithEPA-registeredlowtointermediate leveldisinfectant.[critical] 3. Assembleallequipmentneededfortheinjection: • Useasterilesingle-useneedlesandsyringes • Reconstitutionsolutionsuchassterilewaterorspecificmedication • Alcoholswaborcottonwool • Sharpscontainer 4. PutonPPE(gloves).[stronglyrecommended] 5. Readthelabelcheckingthemedicationandexpirationdates.[critical] 127 6. Swipethetopofthemedicationvial/bottlewith70%alcohol.[critical] 7. Ifusingamulti-dosevial,theairequivalenttothedoseshouldbedrawnupintothe syringefirstandinjectedintothevialtofacilitateeasierwithdrawal.Donotinjectair intoasingle-dosevialorampule. 8. Oncetheloadedsyringeandneedlehavebeenwithdrawnfromamulti-dosevial, administertheinjectionassoonaspossible.[critical] 9. Ifairbubblesareseeninthesyringe,holditwiththeneedleuppermost,tapthebarrel tobringthemtothetopandthenremovethebubblesbypushingtheplungertoexpel theair. 10. Doublechecktoensurethecorrectamountofsolutionisinthesyringe. 11. Preparethepatient’sskinwith70%alcohol. 12. Allowtheskintodry. 13. Insertthesyringetothedepthrequiredforthetypeoftherapyorwhereqisensationis notedfollowingguidelinesforsafeinsertiondepth. 14. Foranintramuscularinjection,drawbackonthesyringetocheckforevidenceof bleeding(ifbleedingispresent,removetheneedleandbeginprocedureagainwitha newdeviceandnewmedication). 15. Ifnobloodflashback,injectthesolutionatamoderaterate. 16. Withdrawneedleandimmediatelydisposeoftheneedleinthesharpscontainer withoutre-capping. 17. Covertheinjectionsitewithacottonballfor5-20seconds. 18. Useanewsterilesyringeandneedleforeachinsertionintoamulti-dosevial.[critical]It isstronglyrecommendedthatsingle-usevialsofinjectablesolutionsbeutilized wheneverpossible. Safety Considerations • • • • • • • • • • • DONOTallowtheneedletotouchanycontaminatedsurface. DONOTreuseasyringe,eveniftheneedleischanged. DONOTtouchthemedicationvialdiaphragmafterdisinfectionwiththe60–70%alcohol (isopropylalcoholorethanol). DONOTenterseveralmultidosevialswiththesameneedleandsyringe. DONOTre-enteravialwithaneedleorsyringeusedonapatient. Avoidinjectioninhairroots,scars,molesandotherskinabnormalities. Avoidinjectionintoanyareaofskinwithanactivelesion. Keepinjectablesolutionatroomtemperaturepriortoinjection. Useneedlesofshorterlengthandsmallerdiameterwheneverpossible. Useanewneedleforeachinjection. Inserttheneedleinaquicksmoothmovementthroughtheskin. 128 • • Injectslowlyandevenly.Ensurethattheplungerofthesyringehasbeenfullydepressed beforewithdrawingthesyringefromtheskin. Injectonlywhenthealcoholusedtocleantheskinhasfullydried. Summary of Safety Recommendations for Clean Injection Technique • • • • • • • • • • • • • • • Critical:FollowCleanNeedleTechnique. Critical:Alwaysestablishacleanfieldbeforestartinganinjection. Critical:Onlyusesingle-usesterileinjectioninstruments. Critical:Alwayswashhandsimmediatelypriortostartinganinjection. Critical:Onlyusesterile,preparedmedications,includingsterilewaterandherbal preparations,meantforinjectionuse;NEVERusehome-preparedsubstancesfor injections. Critical:Allmaterialtobeinjectedmustbemanufacturedspecificallyforthatpurpose andbemaintainedinasterilestatepriortouse. Critical:Donotinjectintoanyskinlesion. Critical:Immediatelyisolateusedneedlesinanappropriatesharpscontainer. Critical:Donotinjectsubstancesdirectlyintoabloodvessel. Critical:Wearglovesforallinjectionprocedures. Critical:Checksyringespriortouseforsterilizationexpirationdates,breaksinthe packagingoranyevidencethatairorwaterhasenteredthepackagingpriortouse. Critical:Allpatientsneedtobetreatedasiftheyarecarriersofbloodbornepathogens suchasHepatitisBorHIV. Critical:Ensurethatthepartofthebodytobetreatedisclean. StronglyRecommended:Cleanskinwith70%isopropylalcoholpriortoinsertinga syringe. StronglyRecommended:Usesinglevialsofinjectablesolutionswheneverpossible. References 1.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages Press,Beijing;1987 2.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress, Seattle,WA.1981. 3.RutalaWA,WeberDJ,GuidelineforDisinfectionandSterilizationinHealthcareFacilities, 2008.CentersforDiseaseControlandPreventionHealthcareInfectionControlPractices AdvisoryCommittee(HICPAC). http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfReviewed December29,2009.AccessedJanuary18,2015. 129 4.NielsenA,KliglerB,KollBS.Addendum:SafetyprotocolsforGuasha(press-stroking)and Baguan(cupping).ComplementTherMed.2014;22(3):446-448. 5.WorldHealthOrganization.WHObestpracticesforinjectionsandrelatedprocedures toolkit.http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdfWHO LibraryCataloguing-in-PublicationData..PublishedMarch2010.. 6.CentersforDiseaseControlandPrevention.InjectionSafety. http://www.cdc.gov/injectionsafety/CDCsRole.htmlAccessedJanuary2013. 7.CentersforDiseaseControlandPreventionOneandOnlyCampaign. http://www.oneandonlycampaign.org/safe_injection_practices.AccessedJanuary2013. 8.CentersforDiseaseControlandPrevention.SafeInjectionPracticetoPreventTransmission ofInfectionstoPatients. http://www.cdc.gov/injectionsafety/IP07_standardPrecaution.html.ReviewedApril1, 2012.AccessedJanuary2015. 130 Part IV – Infections Associated with Acupuncture and Related Healthcare Practices 1. Pathogens Itisessentialthatpractitionersunderstandthemechanismsofdiseasetransmissionandknow thecharacteristicsofinfectiousdiseases,particularlybloodbornepathogenssuchashepatitis andHIV,skininfectionsfromStaphylococcusandStreptococcusandothercommonhealthcare associatedinfections(HAI).Itisimperativeforanacupuncturisttoconsiderthesafetyof patients,clinicians,andothermembersoftheclinicstaff.Knowledgeofthemechanismsand characteristicsofcommonHAIandadherencetoCleanNeedleTechniquewillreducetheriskof thespreadofbloodborneandsurfacepathogens. Readersofthismanualshouldnotethattherearehundredsofpathogensthatarenot addressedherein.Acupuncturepractitionersmustkeepabreastofdevelopmentsinhealthcare associatedinfectionsandstateandnationalstandardstocontrolsuchinfectionsinclinical settings. 2. Mechanisms of Disease Transmission Afundamentalroleoftheimmunesystemistodifferentiateselffromnon-self.This differentiationallowstheimmunesystemtoattackforeignorpathogenicvirusesandbacteria whileprotectingthebody’sownconstituents.Failureofthisabilitytodifferentiateselffrom non-selfmayresultinvariousinfectionsandautoimmunedisorders.Thepresenceofvirusesor bacteriaactivatesimmunefactorstorespondtopathogenicorganisms.Theimmunesystem consistsofhumoralandcellularcomponents.Humoralcomponentsconsistoftheconstitutive complementproteinsystemandimmunoglobins.Theseproteinsarefoundintheliquidfraction oftheblood,aswellasinothertissues.Cellularcomponentsincludeneutrophils, macrophages/monocytes,aswellasBcellsandTcells.Theimmuneresponse,includingthe responsetoinfection,resultsfromthecomplexinteractionbetweenthehumoralandcellular componentsoftheimmunesystem. Thebodyisconstantlyexposedtoinfectiousagents,someofwhicharenormallyfoundinoron specificareasofthebody,especiallyontheskin,inthemouth,respiratorypassageways, urinarytract,colon,andmucousmembranesoftheeyes.Manyoftheseorganismsthatare normallypresentarecapableofcausingdiseaseiftheygainaccesstoothertissuesorifthe immunesystemisineffectiveincontrollingtheinfectiousagent.Inaddition,apersonis intermittentlyexposedtovirulentbacteriaandvirusesfromoutsidethebodythatcancause specificdiseases,suchaspneumonia,streptococcalandstaphylococcalinfections.These infectiousagentsmaybeveryinvasiveandovercomethenaturalbarrierstoinfection. 131 Naturalbarriersincludeintactskinandmucousmembranesofthenose,throat,urethra,and rectum.Naturalbarriersalsoincludestomachacid(gastricacidprovidesnonspecificimmunity toingestedbacterialpathogens)andahealthyrespiratorymucosa,whichcanexpelinhaled pathogens.Otherfactorsintheimmuneresponsethatprotectthebodyfrominvasionand infectionaretheactivityoftheepithelialskinlayerandmucusmembranes,andthecleansing effectsoftears,urine,andvaginalsecretions. Microbescanenterthebodythroughabreakintheskin,suchasacutorwound,orthroughan orifice(mouth,nose,urethra,etc.).Anyinfectiousagentcancauseinfectionifitgainsaccessto tissuesandspacesinthebodywhereitisallowedtoproliferateandinitiateanimmune response.Therearemanypotentialsourcesofinfectiousdiseasesinanacupuncturepractice setting.Theseincludecontaminantsontheskinofpractitioners’andpatients’hands,blood, saliva,sweat,nasalandotherbodilysecretions,dust,clothing,andhair.Infectionsassociated withacupuncturemaybeclassifiedintotwotypesaccordingtothesourceofthediseaseagent –autogenousandcross-infections. Autogenous Infections Autogenous(fromtheLatin“auto”–selfand“genous”–generated)infectionsarecreated whenpathogensalreadypresentinapersonaremovedintothebodyortoanotherlocation withinthebodywheretheyarepathogens.Anexampleofthisisimpetigowherenormalskin bacteriaenterintosubcutaneousareasthroughabreakintheskinandsetupapustule.While therearenospecificstudiesidentifyingwhenacupuncturemaycauseanautogenousinfection, theincidenceoflocalizedskininfectionsasconsequenceofacupunctureislowbutpersistent andimpliesapossibleautogenoussource.(1,2) Oneofthedangersofreusinganeedleduringtreatmentisthetransferofaninfectiousagent fromonelocationtoanother.Organismsthatmayexistinlargequantitiesinoneareacanlead topotentiallylifethreateninginfectionsinotherlocations.Escherichiacoli(E.coli),acommon intestinalorganism,maycauseseriousinfectionsintheurinarybladder,aregionwherethe organismisnotnormallyfound.IntestinalorganismssuchasE.colicancauselife-threatening peritonitisfollowinginjurytothebowel.Asanotherexample,thecommonskinorganism Staphylococcusepidermidiscancauseseriousinfectionswhenthisotherwisecommon bacteriumbeginsproliferatinginopenwounds. Cross-Infections Theseinfectionsarecausedbypathogensacquiredfromanotherpersonorbythe environment.Theymaybeacquireddirectly(e.g.,fromcontactbetweenpatientand practitioner),orbytransfer(e.g.,carriedfromonepatienttoanotherontheunwashedhands ofthepractitionerorcontaminatedimplements).Cross-infectionsmaybeacquiredbythe 132 practitionerandofficepersonnelaswellasbypatients.Someofthemostseriousorganisms thatareassociatedwithcross-infectionsincludethehepatitisBvirus,HIV,andmethicillinresistantstaphaureus(MRSA).Tuberculosisisalsoasignificantpublichealthconcerninthe UnitedStates,includingstrainsofMycobacteriumtuberculosisresistanttoantitubercular antibiotics. Undernormalcircumstancesnaturalbarrierspreventtheinfectiousagentorvirusfromgaining accesstoanewhostandcausinganinfection.Butwhenthenaturaldefensesareweakened,or theinfectiousagenthasalargeenoughquantity,orbioload,tooverwhelmthebody’sdefenses, theorganismorvirusinquestioncancausedisease.Asapractitioner,theacupuncturistmust alwaysbealerttothepotentialfortransferringdisease-causingagentstopatients. Aninfectiousagentcantravelfromonehosttoanotherinavarietyofways,includingbeing carriedondustordropletsofmoistureintheair,beingtransferredinbodyfluids,andby mechanicaltransferfromonesurfacetoanother.Thedensityofaninfectiousagentisoneof thefactorsinriskofcrossinfection.Whilealowbioloadmaybecontrolledbythebody’s properlyfunctioning,ahighbioloadmayoverwhelmtheimmunesystem,moreeasilyresulting inaninfection.Forexample,thehepatitisBvirusisahigh-densityvirus,oneofthefactorsthat facilitatethetransferofthisorganismfrompersontoperson. 3. Bloodborne Pathogens Hepatitis Areviewoftheliteraturesuggeststhathepatitismaybeacomplicationofacupuncture.While reportsofhepatitisrelatedtoacupunctureintheU.S.arelimitedtoreportspriorto1988,there areanumberofretrospectivestudiesandreportsofhepatitisrelatedtoacupunctureinother partsoftheworld.(3,4,5) Therearecurrentlyfiverecognizedtypesofhepatitisviruseswhicharelabeledalphabetically as:A,B,C,D,andE.HepatitisAandEaretransmittedmainlythroughfecalcontaminatedfood andwater.Theothersaretransmittedbybloodorsexualcontact.Hepatitisissuchaconcernin healthcaresettingstheOccupationalSafetyandHealthAdministration(OSHA)hasadopted specificlanguageregardingthetransmissionofhepatitisandrecommendationsfortrainingand vaccinationofat-riskstaffmembers.TheCDCstronglyrecommendsthatallhealthcareworkers bevaccinatedforthehepatitisBvirus(HBV).Whenanemployeeishiredforapositionwhere thereisariskofinfectionwithHBV,OSHArequiresthattheemployermustoffervaccinationto thathealthcareworkeratnocharge.IftheemployeerefusestobevaccinatedforHBV,this employeeshouldberequiredtocompleteandsignadocumentstatingthatheorshe understandstherisksofnotbeingvaccinatedandisrefusingthevaccinationinspiteoftherisk ofHBVinfection.(SeeSection6foranoverviewofOSHAregulations.) 133 Hepatitis A (HAV) HepatitisA(HAV),formerlycalledinfectioushepatitisorshort-incubationhepatitis,isa commoninfectioninconditionsofpoorsanitationandovercrowding.Althoughtransmissionis mainlythroughfecalcontaminatedfoodandwater,contaminatedbloodonhandscanposea potentialhazardinacupuncturepractice.Additionally,inthoseclinicsthatpreparemedicinal teasorotherfoodsforpatients,anawarenessofthetransmissionroutesandprevention practicesiscritical.IninstitutionalorincarceratedsettingsHAVmayspreadfrompersonto personthroughsexualcontact.Goodpersonalhygieneandpropersanitationcanhelpprevent thetransmissionofHAV.TheincubationperiodofHAVis15to50days,withanaverage incubationperiodof28days.(6) UnlikehepatitisB(HBV)orC(HCV),HAVinfectionresultsintheabruptonsetofsymptoms. Symptomsincludeabdominaldiscomfort,lossofappetite,fatigue,nausea,darkurine,and jaundice.Symptomsusuallylastlessthan2months.Althoughthereisnochronicinfection, approximately15%ofpeopleinfectedwithHAVhaveaprolongedorrelapsingcourseofillness lastingaslongas6-9months.IndividualswhohavehadHAVcannotbere-infected. IntheUnitedStates,hepatitisAhasoccurredinlargenationwideepidemicsapproximately every10years,withthelastincreaseincasesin1989.(7)TheHAVinfectionratehasdeclined steadilysincethelastpeakin1995,whentherewere356,000cases.Historically,children2 through18yearsofagehavehadthehighestratesofhepatitisA(15to20casesper100,000in theearlytomid-1990s).Since2002,ratesamongchildrenhavedeclinedandtheincidenceof hepatitisAisnowsimilarinallagegroups.(7)Creditforthechangesisgiventotheissuanceof routinechildhoodvaccinationsforHAVsince1999.Fortunately,mostcasesofHAVare relativelymild,complicationsareuncommon,andchroniccarrierstatesarenotknown.Thereis avaccinationforHAV.TheHAVvaccineisrecommendedforpeopleincommunitieswhere outbreaksofhepatitisAareoccurringandforanyonewhohasbeenexposedtohepatitisA virus.TheCDCdoesnotroutinelyrecommendHAVvaccinationforhealthcareworkerssince theyarenotatincreasedrisk.(8)Routineinfectioncontrolprecautions,particularly handwashing,willpreventtransmission. Hepatitis A Survival in the Environment TheHepatitisAvirusisextremelyhearty.HAVcanliveoutsidethebodyformonths,depending ontheenvironmentalconditions.Thevirusiskilledbyheatingto>185degreesF(>85degrees C)foroneminute.However,theviruscanstillbespreadfromcookedfoodifitiscontaminated aftercooking.Adequatechlorinationofwater,asrecommendedintheUnitedStates,killsHAV thatentersthewatersupply.Seehttp://www.cdc.gov/hepatitis/hav/havfaq.htm. 134 Hepatitis B (HBV) HepatitisBiscausedbythehepatitisBvirus(HBV),adouble-strandedDNA-containingvirus. Between1990and2005theincidenceofacutehepatitisBdeclined79%.Amongpersonsaged 6yearsorolder,0.27%hadchronicHBVinfection(correspondingtoapproximately704,000 personsnationwide.(9,10) Inadults,ongoingHBVtransmissionoccursprimarilyamongunvaccinatedpersonswith behavioralrisksforHBVtransmission(e.g.,heterosexualswithmultiplesexpartners,injectiondrugusers[IDUs],andmenwhohavesexwithmen[MSM])andamonghouseholdcontactsand sexpartnersofpersonswithchronicHBVinfection.(11) Anestimated700,000-1.4millionpersonsintheUnitedStateshavechronicHBVinfection.(12) HepatitisBvirus(HBV,“serumhepatitis”or“long-incubationhepatitis”)isoneofthe bloodbornepathogenspresentingasignificantriskofinfectionintheacupunctureclinic environment.HBVisthesecondsub-typeofhepatitisforwhichavaccineexists.HBVcancause lifelonginfection,cirrhosisoftheliver,livercancer,liverfailure,anddeath.Althoughchronic infectionismorelikelytodevelopinpersonsinfectedasinfantsoryoungchildren,ratesofnew infectionsandacutediseasearehighestinadults.Personswithchronicdiseasethenserveasa reservoirforcontinuedHBVtransmission.(13)HealthcarepersonnelwhohavereceivedHBV vaccineanddevelopedimmunitytothevirusareatvirtuallynoriskforHBVinfection.(14) Transmission of HBV HBVisspreadthroughcontactwithcontaminatedbloodandbodyfluids.Infectedindividuals andthosecaringforthem,sharinglivingspace,orparticipatinginhighriskbehaviors (unprotectedsexwithmultiplepartnersanddruguse)shouldfollowcarefulinfection preventionprocedures.Theinfectedpersonshouldnotshareanyitemsthatmaybe contaminatedwithblood,includingrazorsandtoothbrushes.(Bothrazorsandtoothbrushes areregularlycontaminatedwithmicroscopicamountsofbloodandneedtobetreatedas contaminated.)Barrierprecautionssuchasglovesforhandlingwaste,orcondomsanddental damswheninvolvedinsexualactivities,shouldbeutilized. Forthosewhohaveapersonalhistoryofchronic,activedisease,illicitdrugsandalcoholshould beavoidedtoreducetheriskoflong-termcomplicationsofHBV,suchaslivercirrhosis.Good cleaningofthepatient’senvironmentandpersonalcareitemsisimportant.These precautionarymeasuresshouldbefolloweduntilthepersontestsnegativeforactiveHBV infection. 135 HBV Survival in the Environment HBVcansurviveoutsidethebodyatleast7daysandstillbecapableofcausinginfection. http://www.cdc.gov/hepatitis/hbv/hbvfaq.htm. Individuals at Risk of HBV Infection Itisestimatedthatthereareanestimated800,000-1.4millionpeopleintheUnitedStateswho havechronicHBVinfection.(13)Thenumberofnewinfectionshasdeclinedyearlysincethe 1980s.Routinevaccinationistheprimaryreasonforthisdecline.(13) IndividualsatriskforHBVinfectionthroughoccupationalexposuresarethosewhoarenot immunetoHBVandwhocomeintofrequentcontactwithbloodandbloodproducts. Healthcareworkerssuchasacupuncturists,physicians,dentists,nurses,bloodbankworkers, paramedicalpersonnel,andlaboratorystaffhaveasignificantriskofoccupationalexposureand areatriskofHBVinfectionifnotvaccinated.Otherswhoareatriskincludethosewhocomein contactwithbloodorbodilyfluidsfromanindividualwithahighriskofinfection.Theriskof HBVinfectionintheworkplaceisprimarilyrelatedtothedegreeofcontactwithbloodinthe workplaceandtotheHBVstatusofthesourceperson. WhileHBVcanbetreated,theriskofchronichepatitisissignificant,andpreventionremains themostimportantwaytoreducethepotentialforanegativeoutcome.Intheworkplace,the riskofcontractinghepatitisBisassociatedwithcontactwithinfectedbodyfluidssuchasblood. TheriskofahealthcareworkerdevelopinghepatitisfollowingexposuretoHBVis22%-31%.The riskofdevelopingserologicevidenceofinfectionis37%-62%.(15) OneofthemostcommonmodesofHBVtransmissioninthehealthcaresettingisthe unintentionalinjuryofahealthcareworkerfromaneedlestickorcutbyacontaminated instrument.TherateofHBVtransmissiontosusceptiblehealthcareworkersrangesfrom6%to 30%afterasingleneedlestickexposuretoanHBV-infectedpatient,butisvirtuallyzeroifthat healthcareworkerhasbeenimmunizedagainstHBV.(15)HepatitisBsurfaceantigen(HBsAg) positiveindividualswhoareHepatitisB“e”antigen(HBeAG)positivehavemorevirusintheir bloodandaremorelikelytotransmitdisease.ThepresenceofHBeAgsuggeststhatHBVisinan acutestageandshouldbeconsideredhighlyinfectious.Thenumbersofoccupationallyspread HBVhavedeclinedsincethe1980sfromover10,000annuallytobelow400in2001.Reportsof infectionsin2006wereinfrequent.In1992,theCDCbeganacomprehensivestrategyto eliminateHBVtransmissionintheUnitedStates,includingthroughvaccination.In2005itwas notedinfollow-upsurveillancethat75%ofhealthcareworkershavebeenvaccinated.(15) Othergroupsatriskincludethosewholiveincrowdedorunsanitaryconditions(including prisonersandcertainimmigrantpopulations),havemultiplesexualcontacts,menwhohave homosexualcontact,liveinthesamehousewithsomeonewhohaschronicHBV,havesexwith 136 someoneinfectedwithHBV,havehemophilia,areapatientorworkinahomeforthe developmentallydisabled,traveltoareaswherehepatitisBisendemic,areinjectiondrugusers, orhaveseveraloftheseriskfactors.(13) Exposure to HBV HBVistransmittedthroughpercutaneousorparenteralcontactwithinfectedblood,body fluids,andbysexualintercourse.HBVisonlyspreadwhenblood,semenorotherbodilyfluids (OPIM)enterthebodyofanotherpersonthroughanorifice,abreakintheskinorthrough mucusmembranes.HBVmayalsobetransmittedperinatally.HBVisnotspreadthroughsharing eatingutensils,casualcontact,orbreastfeeding.Itisnotspreadbycontaminatedwateror food.HBVisabletoremainonanysurfaceitcomesintocontactwithforaboutaweek,e.g., table-tops,razorblades,bloodstains,withoutlosinginfectivity.HBVdoesnotcrosstheskinor themucousmembranebarrier.Somebreakinthisbarrier,whichcanbeminimaland insignificant,isrequiredfortransmission.(12,16) HealthcareworkerswhoarenotimmuneareatahigherriskforHBVthanthegeneralpublic duetotheirpotentialforfrequentoccupationalexposuretoandbloodproducts,aswellas otherbodyfluids. HepatitisBmustberecognizedasanoccupationalhazardforacupuncturists,asitisforother healthcareprofessionalswhoseprocedurescommonlyincludethepenetrationoftheskinor causeexposuretobloodandotherbodyfluids.Invasiveprocedures,wherethereis considerableriskofexposuretocontaminatedbloodandbodyfluids,posethegreatestriskof occupationalinfectionfromHBV.TheCDCstronglyrecommendsthatallpersonnelworkingin suchareasshouldscrupulouslyfollowStandardPrecautions.Disposableequipmentand protectiveclothingshouldbeusedwhenappropriate,andappropriatedisinfectionprotocols employed. Intheeventofexposure,hepatitisBimmuneglobulinandhepatitisBvaccinehavebeenshown tobeeffectiveresponses.Forthehealthcareworker,multipledosesofhepatitisBimmune globulinorhepatitisBvaccinealoneis70%-75%effectiveinpreventingsequelaeofHBV exposure.(15) HBV Vaccination AvaccineagainsthepatitisBwasdevelopedin1981.Anyhealthyadultwithanintactimmune systemwilllikelyrespondtooneseriesofthevaccine.Atthistimeitisclearthatimmunity clearlylastswellovertwentyyears,butsincethevaccinehasonlybeeninexistencesince1981, nooneyetknowsexactlyhowlongimmunitywilllast.Thereisnotestingrecommendedbefore vaccination;but1-2monthsfollowingcompletionoftheseries,atiterisrecommendedto assesstheresponse.Ifthereisaresponse,nofurtherboostersorseriesarerecommended.If 137 thereisnoresponse,thenasecondseriesmaybegivenandwillusuallybesuccessful.There arealownumberofnon-respondersevenafterthesecondseries;nofurthervaccineis recommendedforthem.(17) Vaccinationisrecommendedforpersonnelperforminginvasiveprocedures,cleaning contaminatedequipment,orperformingdutiesinanareawherethereisariskofexposure.The CDCrecommendsthatallhealthcareworkersbevaccinatedagainstHBV.OSHArequiresall employerstoofferHBVvaccinationtopersonnelperforminginvasiveproceduresorcleaning contaminatedequipment.(14)InOctober1997,theAdvisoryCommitteeonImmunization PracticesexpandeditshepatitisBvaccinationrecommendationstoincludeallchildrenaged018years. The HBV Infection Process TheincubationperiodforHBVis45to160days.(6)Duringthisperiod,theinfectiousvirus appearsintheblood,anditmayappearinthefecesandsemen.Duringthisperiodtheinfection maybespreadtootherpeopleeventhoughnosymptomsarepresent.HBVearlysymptoms oftenbeginwithmildflu-likesignsandsymptomssuchasafever(in60%ofcases),general malaise,ortheinsidiousonsetofanorexiaandabdominalpain.Othersymptomsmayinclude chills,nausea,jointpains,rash,anddiarrhea.Typicallythesesymptomslastfromtwotosix weeks.Thesesymptomsarefrequentlyfollowedbyaperiodofextremefatigueanddepression thatcanextendforseveralmonths. Practitionersshouldbeawarethatsomeindividualsinfectedwiththevirusdevelopmild symptomsorareasymptomatic.Approximately30%ofthoseinfectedhavenosignsor symptoms.(17)ChildrenwithHBVareoftenasymptomatic.However,asymptomaticpatients areasinfectiousasthosewhoaresymptomatic.Onlyabloodtestwilltellwhetheranindividual isinfectedwithHBV. Fully70%ofpeoplewhohaverecoveredfromthesymptomaticstageofthediseasearestill infectiousforthreemonthsormoreaftersymptomshavesubsided.Amonginfantswhoacquire HBVinfectionfromtheirmothersatbirth,upto90%becomechronicallyinfected.Theolder youarewheninfected,thelowertherateofchronicinfection,with25%–50%ofchildren infectedatage1–5yearsbecomingchronicallyinfected,andamongolderchildrenandadults approximately6-10%ofallacuteHBVinfectionsprogresstochronicinfection.(6) IfapractitionerbecomesinfectedwithHBV,heorshemayunknowinglytransmitHBVto patientsorofficestaffthroughtransmissionofbloodfromcutsoropensores.Professionally andlegallytheramificationsofthisformoftransmissionareenormous.Highstandardsof hygieneandCleanNeedleTechniquewillgreatlyreducetheriskofHBVinfectionfor practitioners,aswellaspatients.ApractitionerwithacuteHBVshouldnotpracticeduringthe 138 infectiousperiod.Ifaproviderisfoundtobeinfected,heorsheshouldconsultwithaphysician beforegoingbacktowork.(14) Treatment of HBV WhileHBVcanbetreated,theriskofchronichepatitisissignificant,andpreventionremains themostimportantwaytoreducethepotentialforanegativeoutcome.Intheworkplace,the riskofcontractinghepatitisBisassociatedwithcontactwithinfectedbodyfluidssuchasblood. TheriskofahealthcareworkerdevelopinghepatitisfollowingexposuretoHBVis22%-31%.The riskofdevelopingserologicevidenceofinfectionis37%-62%.Thisriskissignificantlyhigher thantheapproximately0.3%citedforHIV.(15) Intheeventofexposure,hepatitisBimmuneglobulinandhepatitisBvaccinehavebeenshown tobeeffectiveresponses.Forthehealthcareworker,multipledosesofhepatitisBimmune globulinorhepatitisBvaccinealoneis70%-75%effective.(14-19) Combiningthesetwotreatmentsincreasesefficacy.TheHBVvaccineissafeandeffective. Hepatitis C (HCV) HepatitisCvirus(HCV)infectionisthemostcommonchronicbloodborneviralinfectioninthe UnitedStates.Firstidentifiedin1988,HCVisthecausativeagentforwhatwasformerlyknown asnon-Anon-Bhepatitis,andisestimatedtohaveinfectedasmanyas242,000Americans annuallyduringthe1980s.Manyofthoseinfectedarenotawareoftheirinfection,resultingin chronicliverdiseasethatmaynotbecomeapparentfor10-20years. HCVisaviruscontainingasinglestrandofRNAthatismosteffectivelytransmittedby percutaneouscontactthroughinjectiondruguseorexposuretoinfectedbloodorblood products. Today,mostpeoplebecomeinfectedwiththehepatitisCvirusbysharingneedlesorother equipmenttoinjectdrugs.Before1992,whenwidespreadscreeningofthebloodsupplybegan intheUnitedStates,HepatitisCwasalsocommonlyspreadthroughbloodtransfusionsand organtransplants.(20) WhileHCVmaybetransmittedthroughsexualcontact,contractingaHCVinfectionthroughthis routeisconsiderablylessefficient.Theriskoftransmissionfromsexualcontactisbelievedtobe verylow.Theriskincreasesforthosewhohavemultiplesexpartners,haveasexually transmitteddisease,engagein“roughsex”,orareinfectedwithHIV.(21) In2013,therewereanestimated29,718newhepatitisCvirusinfectionsintheUnitedStates. TheCDCestimatesthat2.7-3.9millionpeopleintheUnitedStateshavechronicHepatitisC 139 infection.Manypeoplewhoareinfectedneverhavesymptomsandthereforenevercometo theattentionofmedicalorpublichealthofficials.(21) PeakratesofHCVoccurredinthe1980s,andhavedeclinedduetoareductionininfections resultingfrominjectiondruguse.Whilenewinfectionsarelowerthan1980peakinfection rates,HCVinfectionisstillthemostcommonblood-borneinfectionintheUnitedStates.(20) Theriskofseroconversionafterpercutaneousoccupationalexposureisapproximately1.8%if thesourcebloodisseropositiveforHCV.Thisisconsiderablyhigherthantheriskof percutaneousoccupationalexposureduetoHIVseropositivebloodandlowerthantheriskof seroconversionafterpercutaneousoccupationalexposuretoHBVseropositivefluids.(15) Acute Symptoms of Hepatitis C ThosewhomanifestsymptomsofacutehepatitisCwillexperiencesymptomssimilartothe othercasesofacutehepatitis,includingflu-likesymptoms,jointaches,jaundiceand/ormild skinrash.Othersymptomsincludealossofappetite,abdominalpain,darker-than-normalurine colorandlightorgreycoloredstools.Practitionersshouldbeawarethatlessthan30%ofthose infectedwithhepatitisCmanifestacutediseasesymptoms. Risk Factors for HCV Infection Individualswhoinjectdrugs,eveniftheydidsoonlyononeoccasionmanyyearspreviously, havethehighestriskofHCVinfection.Individualswithahistoryofinjectiondruguserepresent 60%ofthoseinfected.HCVisrapidlyacquiredfollowinginjectiondrugusethroughsharing needlesandotherequipment.Asmanyas80%ofinjectiondrugusersarefoundtobeinfected withHCVandareoftenco-infectedwithHIV(30-50%).(22)OtherrisksofHCVinfectioninclude transfusionsandtransplantsbeforethescreeningthatiscurrentlyinplace(before1992)and, toalesserdegree,sexualcontact(15%).ThereisariskofoccupationalexposureforHCV, particularlywherethereisexposuretolargeamountsofblood,suchashemodialysisand surgeries.HCVisspreadfrommothertobaby.About10%ofthoseinfectedhaveno recognizablesourceofinfection.WhileitispossibleforHCVtobetransmittedfrom percutaneousexposuretoblood,exposuressuchasacupuncture,tattooing,orbodypiercing havenotbeenshowntoplacepeopleatincreasedriskforHCVinfection.HCVismostefficiently transmittedbyexposuresthatinvolvedirectpassageofbloodthroughtheskin,particularly withhollow-boreneedles. WhiletheriskofoccupationalexposureleadingtoHCVseroconversionmaybelimitedto needleswithalumen,itisimportanttostatethataswithHIVandHBV,exposurefollowinga needlestickinvolvinganacupunctureneedlemustbetreatedasapossiblesourceofinfection. 140 HCVhasbeenassociatedwithacupunctureinsomeretrospectivestudiesofacupunctureAEs. (5,23) HCV Survival in the Environment ThehepatitisCvirus(HCV)canremainviableoutsidethebodyfor4-5days.(24) Consequences of HCV Infection About15-25%ofthoseinfectedcleartheirHCVinfectionwithoutfurtherproblems.The remainder(75-85%)willdevelopchronicinfectionandapproximately60-70%willgoonto developchronichepatitis.(Achronicinfectionisthechronicpresenceoftheagent,HCV,and thepatient’simmuneresponse.Chronichepatitisischronicinflammationoftheliverthatmay becausedbychronicinfection.Whiletheyoftengotogether,theyaredefineddifferentlyand assuchasnotinterchangeable.)Cirrhosisoftheliveroccursinatleast5-20%ofpatientsovera 20-30yearperiodandhepatocellularcarcinoma(livercancer)occursin1-5%ofcases.HCVassociatedchronicliverdiseaseisthemostfrequentindicationforlivertransplantationamong adults.(6,25)DrugtreatmentisanimportantadjuncttocareformanypersonswithHCV. Thereisnovaccineforthisdisease.PeopleinfectedwithHCVshouldbevaccinatedforHAVand HBVtopreventfurthercomplicationsoftheirdisease. TheincubationperiodofHCVis14-180days,withmostcasesoccurring5to10weeksafter exposure.(6,25)Theperiodofcommunicabilityextendsfromoneweekafterexposurethrough thechronicstage.Theonsetisinsidiousandaccompaniedbyanorexia,nausea,vomiting,and jaundice.ThecourseissimilartoHBVbutmoreprolonged. TherapyforhepatitisCisarapidlychangingareaofbiomedicalclinicalpractice.Treatment decisionsarebasedonliverenzymelevels,genotypeoftheinfectingvirus,andconditionofthe liver,includingtheextentofscarring.Current treatment mostcommonlyincludesdrug cocktailsutilizingSOVALDI®(sofosbuvir)andHarvoni(ledipasvir/sofosbuvir).(26) Hepatitis D (HDV) HDV,sometimesknownasdeltahepatitis,isadefectivevirusthatrequiresconcurrentHBV infectionfordevelopmentofdisease.IntheU.S.,mostcasesofhepatitisDoccurininjection drugusersandhemophiliacs.TransmissionofhepatitisDisthroughpercutaneousormucosal contactwithinfectiousblood.ThereisnovaccineforHDV;however,sincetheHDVvirus requiresthepresenceofHBV,vaccinationagainstHBViseffectiveagainstHDVrelateddisease. TheoutcomeofsimultaneousHBVandHDVisnodifferentfromtheoutcomeofHBValone. However,whenchronicHBVinfectionisaccompaniedbyHDV,itmayleadtosevere, fulminatinghepatitisortransformamildorasymptomaticchronicHBVintoamoresevere diseaseprocess,oradiseaseprocessthatmaybeacceleratedduetoincreasedscarringofthe 141 liver.PreventionofHepatitisDinpersonswhoarenotalreadyHBV-infectedcanbe accomplishedthroughHepatitisBvaccination.(27) HDV Survival in the Environment HDVisfoundwithHBV.HBVcanbecapableofcausinginfectionforaweek.Mostexperts believethatHDVdoesnotlastaslongbutitisbesttotakethesameprecautionsaswithHBV. Hepatitis E (HEV) HepatitisE,likehepatitisA,isspreadbyfecal-oraltransmission(28).Mostoutbreaksarefound indevelopingcountries,wheredrinkingwateriscontaminatedbyfecesfrominfectedanimals andhumans.HEVisrarelyseenintheU.S.,withtheexceptionoftravelerstodeveloping countries,particularlySouthAsiaandNorthAfrica.Infectionfrompersontopersonisless frequentthanwithhepatitisA.Theincubationperiodis15to60days,withanaverageof40 days.Thetimeperiodis15to60days,withanaverageof40days.Thetimeperiodof communicabilityisunknown.Thediseaseischaracterizedbysuddenonsetoffever,malaise, nausea,andanorexia.Thediseasevariesinseverityfromamildillnesslasting7to14daystoa severelydisablingdiseaselastingseveralmonths.Jaundicemaybepresent.Pregnantwomen haveamortalityrateof20%.Thereisnoevidenceofachronicinfectioninlong-termfollow-up ofpatientswithHEV.ThereisnovaccineforHEV. Chronic Carriers of Hepatitis Chroniccarriersareindividualswhocontinuetoshedhepatitisvirusthroughbodilyfluidsand excretionslongafterinfection.Theyareclassifiedintotwocategories:ChronicPersistentand ChronicActive.Achronicpersistentcarrierisasymptomaticorhasminimalsymptomsbutcan continuetoinfectothers.Achronicactivecarrierhasprogressivesymptomaticdiseasethat continuestodamagetheliver.Symptomsincludemalaise,weightloss,lossofappetite,and oftenjaundice.PatientswithhepatitisAandEneverdevelopchronicstates.HepatitisB becomeschronicin5to10%ofinfections(thisratevariesdependingontheageofthepatient), HCVin75-85%ofinfections.Togetagoodhepatitishistoryaspartofthepatientintake,ask aboutcontactwithbloodproductssuchastransfusions,dialysis,andinjectiondruguse. Patientswhohavereceivedtransfusionsordialysisbefore1990orwhohaveahistoryof injectiondrugusepresentanincreasedrisk.Also,manypatientsinapublichealthcaresetting, suchaschemicaldependency,HIV,andTBclinics,mayhaveahistoryofsomeformofhepatitis, butmaynotknowwhattypeandmaynotknowwhethertheyarechroniccarriers.Theuseof CleanNeedleTechniqueandStandardPrecautionsistheonlyeffectivewaytoprevent transmissionofviralhepatitisdiseases. 142 Prevention of Hepatitis OneofthemostcompellingreasonsforthedevelopmentoftheCleanNeedleTechnique protocolin1984wastoprovideguidelinestopreventthetransmissionofhepatitiswithin acupunctureclinicsettings.Sincethattime,theincidenceofhepatitisBthroughacupuncture hasdramaticallydecreased.(2,3)ContinuingstrictadherencetoCleanNeedleTechniqueis essentialinordertopreventtransmissionofHBVorarelatedvirustopatients,practitioners andstaff. ThelackofanyevidenceoftransmissionofviraldiseasefromacupunctureneedlesintheU.S. since1990canbedirectlyassociatedwiththeintroductionofCNTcourseandtheuseofsingleusedisposablesterileneedles. Table 1: Summary of Hepatitis Characteristics (Seehttp://www.cdc.gov/hepatitis/resources/professionals/pdfs/abctable.pdf)fordetails aboutHepatitisA,BandC) Hepatitis Incubation Transmission A B Onset Vaccine Chronic 15-50days Fecal-oral Abrupt Yes No 45-160days Bloodborne Insidious Yes Dependson agegroup (6-10%in adults; higherin children) C D 14-180days Bloodborne Insidious No 75-85% Unknown Percutaneousor mucosalcontact withinfectious blood Insidious No Unknown E 15-60days Fecal-oral Abrupt No No Human Immunodeficiency Disease (HIV) Thehumanimmunodeficiencyvirus(HIV)isanRNA-containingvirusthatinhumansleadstoa constellationofproblemsextendingfromdecliningimmunefunctionthatleadstoanend-stage syndromeinuntreatedpatients,calledtheacquiredimmunedeficiencysyndrome(AIDS).These medicalproblemsmaybeexacerbatedbyco-infectionwithotherdisease-causingagentssuch astheherpesviruses.HIVcontinuestobeagrowingmedicalchallengeworldwide.Mathersand 143 Loncarindicatethatoverthe25yearperiodfrom2006to2030,between89millionand117 millionpeoplewilldieofHIV/AIDS.(29) TheCentersforDiseaseControlandPrevention(CDC)reportsthatin2012,41,505casesofHIV werediagnosedintheUnitedStates.(30) Todate,therearenoconfirmedcasesofoccupationalHIVtransmissionfollowinganaccidental needlestickinvolvinganacupunctureneedleintheUnitedStates.Therewasacasereportfrom 2003ofapatientinThailandindicatingthatacupuncturewastheonlyknownriskforthe seroconversionofapreviouslyHIVseronegative60year-oldfemale.(31) ScientistshaveidentifiedatypeofchimpanzeeinWestAfricaasthesourceoftheHIVthat infectshumans.Thevirusmostlikelyjumpedtohumanswhentheyhuntedthesechimpanzees formeatandcameintocontactwiththeirinfectedblood.Overseveralyearsthevirusspread acrossAfricaandlaterintootherpartsoftheworld.TwotypesofHIVhavebeenidentified: HIV-1andHIV-2.Althoughtheyhavesimilarepidemiologicalandpathologicalcharacteristics, theyaredifferentserologicallyandgeographically.Generally,HIV-2hasaslower,somewhat mildercourse.Itseemstobelessinfectiousearlyoninthedisease,butbecomesmore infectiousovertime.ItispredominatelyfoundinWestAfrica.Casesareseeninfrequentlyin theU.S.andusuallyhavesomeassociationwithWestAfrica.HIV-1isthemorevirulentvirus andismoreeasilytransmitted.ItisthecauseofthemajorityofHIVinfectionsglobally.(32) HIV Transmission Blood-to-bloodcontactisthemostdirectmethodoftransmittingHIV(aswellasHBV).When infectedbloodentersthebloodstreamofanuninfectedindividual,thereisaprobabilityof infection,althoughthisriskismuchlowerthanthatforHBV.Prospectivestudiesofhealthcare workers(HCWs)haveestimatedthattheaverageriskforHIVtransmissionafterapercutaneous exposureisapproximately0.3%,theriskofHBVtransmissionis6to30%,andtheriskofHCV transmissionisapproximately1.8%.(33)Themostcommonmodeoftransmissionis percutaneousexposurethatoccursfromcontaminatedinstruments(mostlyfromsuturingand needlesticks),orcontactofcontaminatedbloodwithnon-intactskin.Therisk,however,is extremelylowifStandardPrecautionsarefollowed.StandardPrecautions,asdefinedbythe CDC,includetheuseofbarriersasgloves,masks,gowns,goggles,andpreventiontechniques appropriatetotheparticularhealthcaresetting,dependingonthespecificrisksinvolved.(34) ThereisnoevidencethatHIVisspreadbycasualcontact.Casualcontactconsistsofanyactivity thatdoesnotinvolvetheexchangeofbodyfluidssuchasblood,semen,orvaginalsecretions. Non-riskcasualcontactincludesshakinghands,touching,hugging,holdinghands,orkissing. TheuseofobjectshandledortouchedbyanHIV-infectedperson(forexample,atelephoneor toiletseat)hasalsonotbeenshowntospreadthevirus. 144 HIV Survival in the Environment HIVdoesnotsurvivelongoutsidethehumanbody(suchasonsurfaces),anditcannot reproduceoutsideofthebody.Outsideofthebody,thevirusdieswithinminuteswithoutthe temperaturenecessaryforitssurvival.http://www.cdc.gov/hiv/basics/transmission.html Risk of Transmission through Invasive Procedures Ingeneral,theriskforHIVtransmissionbetweenpatientsandhealthcareworkersisverylow. (29,31)AdherencetoCDC-recommendedproceduresforStandardPrecautionsreducestherisk significantly.Practitionersshouldpreventdirectbloodcontactandcarryoutproperdisinfection proceduresasdescribedinthismanualandatthewebsite: http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standared-precautions.html Individuals at Risk of HIV Infection ThefirstcasesofAIDSintheUnitedStateswerereportedin1981.Bytheendof1981,atotalof 316casesofthisnewlydiscoveredsyndromewerereportedtotheCDC.Duringthe1980sas manyas150,000peoplebecameHIVinfectedeachyear.Bytheearly1990stheinfectionrate droppedtoabout40,000eachyear.Attheendof2009,anestimated1,148,200personsaged 13andolderwerelivingwithHIVinfectionintheUnitedStates,including207,600(18.1%) personswhoseinfectionshadnotbeendiagnosed.(35)ThenumberofAIDScasesbegantofall dramaticallyin1996withtheadventofproteaseinhibitors. ItisimportanttonotethatthepopulationdistributionofHIVhaschanged.InitiallyHIVwas foundprimarilyamongmenwhohadsexwithmen,injectiondrugusers,sexworkers,and transfusionrecipients.TodayHIVisnolongerlimitedtotheseinitialpopulations.Recently, morecasesareassociatedwithunprotectedsexbetweenmixedgendercouples.Dueto successfulprotocolsforperinatalcases,newbornsareacquiringHIVfromtheirmothersmuch lessfrequently.EffortstotestallexpectantmothersandstartthosefoundHIVpositiveon antiretroviralmedicationhavebeensuccessful.However,anyonewhoengagesinat-risk behaviors(mainlysexwithaninfectedpartnerwithoutbarriermethodsandneedlesharing)or isinaprofessionwithariskofbloodexposure(suchashealthcareworkers)isindangerof contractingHIV. HIVseroconversioninhealthcareworkersisrare,butStandardPrecautionsmustbe maintained.Ofthosehealthcarepersonnelforwhomcaseinvestigationswerecompletedfrom 1981-2010,57haddocumentedseroconversiontoHIVfollowingoccupationalexposures.The routesofinfectionincluded48thatwereduetopunctureorcutinjuries.Forty-ninehealthcare personnelwereexposedtoHIV-infectedblood;threetoconcentratedvirusinalaboratory;one tovisiblybloodyfluid;andfourtoanunspecifiedfluid.(36) 145 TheCDCisalsoawareof143othercasesofHIVinfectionoradiagnosisofAIDSamong healthcareworkerswhohavenotreportedotherriskfactorsforHIVinfectionandwhoreporta historyofoccupationalexposuretoblood,bodyfluids,orHIV-infectedlaboratorymaterial,but forwhomseroconversionafterexposurewasnotdocumented.InordertopreventHIV infection,itiscriticaltouseStandardPrecautionswitheverypatient.(36) Thereremainsasignificantriskofinfectioninthehealthcareworkplace.In1996,therewere 786,885percutaneousandmucocutaneousexposurestopotentiallyinfectioussubstances amonghealthcareworkers(HCWs)intheUnitedStates.(37) BecauseofthelongincubationperiodofHIV(anaverageof8-10yearsfrominfectiontothe developmentofAIDSinindividualsnotoneffectiveantiretroviraltherapy),thevastmajorityof HIV-infectedindividualshavenosymptomsandmaynotknowtheyareinfected.However, anyoneinfectedwithHIVmaybeabletotransmitthevirustoothersthroughbodilyfluids, includingblood,semen,orvaginalsecretions,regardlessofwhetherornottheyhave developedAIDS.Itisbeneficialtoroutinelyincorporateriskassessmentstrategiesintothe patientevaluationtodeterminethelikelihoodofexposureto,orthepresenceof,HBVorHIV infectionssuchas: 1. Patient’shistoryregardingexposuretobloodandbloodproducts.(“Haveyouhada bloodtransfusion?”) 2. Patient’shistoryofdruguse.(“Whatdrugshaveyouusedinthepasttenyears?”) 3. Patient’ssexualhistory/historyofsexuallytransmitteddiseases.(“Howmanysex partnershaveyouhadinthelasttwoyears?”) Testing Voluntarytestingisencouraged.Rapidtestscanbedonenowwithresultsbeingavailable within20minutes.AspartofitsstrategicplantoreduceHIV,theCDChasrecommendedthat everyonebetweentheagesof13and64betestedatleastonceasabaseline.(38)Anyone fallingintohighriskcategoriescancontinuetobetestedregularlyaspartofroutinemedical care.Testingisespeciallyimportantforthosewhofallintothefollowingcategories: 1. 2. 3. 4. 5. 6. 7. 8. Personsinprofessionswithahighriskofexposure. Personswhohavehadasexuallytransmitteddisease. Thosewhohaveahistoryofinjectiondruguseandsharedneedles. Menwhohavehadsexwithothermensince1978. Menandwomenwhohavetradedsexformoney,food,drugs,orotheritems. Peoplewhohavehadmultiplesexpartnersandusedintravenousinjecteddrugs. Sexualorneedle-sharingpartnersoftheabove. Anywomanthinkingofbecomingpregnant. 146 ForspecificinformationontestingforHIVcheckwithyourlocalhealthdepartment. Reporting Auniformcasedefinitionandcasereportformisnowusedinallfiftystatesforthereportingof diagnosedcasesofAIDS.RevisionsinthedefinitionofclinicalAIDShavebroadenedtherangeof AIDS-indicatordiseasesandconditions.UsingHIVdiagnostictestshasimprovedthesensitivity andspecificityofthedefinitionoverthepast20years. The HIV Infection Process HIVtargetsseveralcelltypes,includingtheCD4(T4)lymphocyte,whichinterruptsthecellmediatedresponsetoantigens.(39)ThisT4lymphocytepopulationinturnreplicatesHIV. DamageresultsinalowerCD4(T4)cellcountleadingtoareductionofthiscellpopulation, producingimmunedeficiency.SincetheCD4(T4)lymphocyteplaysacrucialroleinregulation oftheimmunesystem,depletionofthesecellsduetoHIVinfectionreducestheimmune response. HIVcausesprogressivedamagetothehumanimmunesystemoveralongperiod,makingthe individualvulnerabletoahostofinfectionsandmalignancies.Thesyndromeknownas AcquiredImmuneDeficiencySyndrome(AIDS)representsthelatestageofHIVinfection.This syndromeisassessedwhenthepatientisHIVseropositiveandhasanabsoluteCD4countof lessthan200cellspermicroliter,oroneormoreAIDSdefiningillnesses,suchasPneumocystis carniipneumonia,cryptosporidiosis,orKaposi’ssarcoma. InfectionwithHIVcanpresentalongacontinuumrangingfromasymptomatictosymptomatic. Patientscanexhibitoneormoreofthesymptomsassociatedwithimpairedimmunefunction. InitialHIVinfectionissometimesfollowedwithin2to4weeksbyafebrileillnessresembling mononucleosisorinfluenzawhichresolvesspontaneouslyandwhichmanypeopledonotnote assignificantatthetime.Itisduringthisearlytimethatpeopleareveryinfectious.Some peopleinfectedwithHIVremainrelativelyhealthyformanyyearsbeforethesymptomsofHIV infectionappear.ApproximatelyhalfofthepeoplewithHIVdevelopAIDSwithin10yearsafter becominginfected.ThemostcommonsymptomsofHIVincludefever,malaise,bodyaches, maculopapularrash,lymphadenopathy,andheadache.Othersymptomsincludepersistent feverandnightsweats;rapid,unexplainedweightloss;chronicdiarrheanotexplainedbyother causes;persistentcoughthatisnotassociatedwithsmokingorinfluenza;andflatorraised pigmentedlesionsontheskinrangingincolorfromfaintpinktored,brown,orblue.Manyof thesesymptomsarenon-specificandareseeninotherconditions.Dataindicatethatmost peopleinfectedwithHIVeventuallydevelopAIDS.Theseindividualsdevelopopportunistic infectionsandneoplasticdisordersrarelyseeninindividualswithahealthyimmunesystem. Theseinfectionsincludeesophagealcandidiasis,cytomegalovirus,Kaposi’ssarcoma,and 147 Pneumocystiscariniipneumonia,themostcommonopportunisticinfectionandcauseofdeath inAIDSpatients. TheclinicalpresentationsofAIDSpatientsvaryextensively.IndividualsmaypresentwithHIV wastingdisease,whichischaracterizedbysevere,involuntaryweightloss,chronicdiarrhea, constantorintermittentweakness,andfeverfor30daysorlonger.IfHIVinfectscellsinthe cerebrospinalfluid,individualsmaydevelopHIVencephalopathy,myelopathy,ordementia withsymptomsrangingfromapathyanddepressiontomemoryloss,motordysfunction,and death. Presently,itisnotknownwhysomepeopleinfectedwiththeHIVvirusdevelopsymptoms morequicklythanothers.Researchershaveproposedthatcertainco-factorssuchasstress, poornutrition,alcoholordrugabuse,andcertainsexuallytransmitteddiseases(STDS),suchas syphilisorhepatitis,maytriggerthevirustomorerapidlyreplicateorplaceotherstressorson thebodysystems.ItisclearthatwhenHIVisidentifiedearlyandgoodhealthcareisprovided, includingantiretroviraltreatmentregimens,HIVcanbemanagedasalongtermchronic medicalcondition.Todaytherearemanyinfectedindividualslivingverylonglives.(38) Treatment of HIV AIDSrepresentstheendstageoftheclinicalspectrumofHIV.Atthepresenttimethereisno cureorvaccineforAIDS,althoughavarietyofmedicationsarebeingusedtoslowthe progressionofthediseaseandtreatsomeoftheopportunisticinfections.(38) Thenumberofdrugsandthevarietyoftreatmentapproacheshavegrownexponentiallysince theapprovalofAZTin1987.ThosepractitionerswhoroutinelyworkwithHIVpositiveandAIDS patientsshouldkeepabreastofthedrugcombinationsbeingusedfortreatment,theirside effectsandanyherb-druginteractions.Thelistofthosedrugs,sideeffectsandinteractionsare changedandupdatedregularly;inclusionofanupdatedlistinthismanualisnotfeasible. Additional Risks to Healthcare Workers (HCWs) AnadditionalrisktopractitionersworkingwithpersonswithHIVisthatsomeofthecommon secondaryinfectionsinthispopulationarethemselvescontagious.Thesemayinclude tuberculosis,staphylococcalinfections,herpesviruses,andhepatitis.(38).Appropriatecontrol precautionsshouldbetakenandmayincludemasksincaseofrespiratoryinfectionandgloves incaseofskinlesions.StandardPrecautionsshouldbepracticedwithallpatients.Itis imperativetoassumeanypatientmaybeHIVseropositiveandtouseStandardPrecautions withallpatients. 148 4. Other Healthcare Associated Infections Healthcare-associatedinfections(HAIs)areinfectionsthatpatientsdevelopduringthecourse ofreceivinghealthcaretreatmentforotherconditions.Theycanhappenfollowingtreatmentin healthcarefacilitiesincludinghospitalsaswellasoutpatientcentersandcommunityclinics. Theycanbecausedbyawidevarietyofbacteria,fungi,andviruses.Someofthemorecommon HAIsthatmayberelatedtotherapeuticneedlingandotherclinicalproceduresarediscussed below. Tuberculosis Tuberculosis(TB)iscausedbythebacteriumMycobacteriumtuberculosis.Thisorganismisan acid-fastbacteriumwithawaxycoat,istransmittedthroughtheair,andhasalongincubation periodofupto12weeks.(40,41) Atotalof9.421TBcases(arateof2.96casesper100,000persons)werereportedintheUnited Statesin2014.BoththenumberofTBcasesreportedandthecaseratedecreased;this representsa1.5%and2.2%decline,respectively,comparedto2013.Thenumberofreported TBcasesin2014wasthelowestrecordedsincenationalreportingbeganin1953.(42) WhileTBinfectionratesareindeclineintheUnitedStates,itremainsasignificantsourceofrisk inthehealthcareenvironment.Jensenetal.(41)listthefollowingpopulationswhoare especiallyatriskforTB: • • • • • • • Foreign-bornpersons,includingchildren,especiallythosewhohavearrivedinthe UnitedStateswithin5yearsaftermovingfromgeographicareaswithahighincidence ofTBdisease(e.g.,Africa,Asia,EasternEurope,LatinAmerica,andRussia)orwho frequentlytraveltocountrieswithahighprevalenceofTBdisease. Residentsandemployeesofcongregatesettingsthatarehighrisk(e.g.,correctional facilities,long-term-carefacilities[LTCFs],andhomelessshelters). Healthcareworkers(HCWs)whoservepatientswhoareathighrisk. HCWswithunprotectedexposuretoapatientwithTBdiseasebeforetheidentification ofTBandinstitutionofcorrectairborneprecautionsforthispatient. Certainpopulationswhoaremedicallyunderservedandwhohavelowincome,as definedlocally. PopulationsathighriskwhoaredefinedlocallyashavinganincreasedincidenceofTB disease. Infants,children,andadolescentsexposedtoadultsinhigh-riskcategories. Personswhoareinfectedaremorelikelytoprogresstoactivediseaseiftheywereinfected withintheprevioustwoyears,areHIVseropositiveorinsomeotherway 149 immunocompromised,aninfantorchildlessthanfouryearsofage,haveoneofseveral disorderssuchassilicosisordiabetesmellitus,orhaveahistoryofimproperlytreatedTB. ThepresenceofHIVcontributestotheTBinfectionrate,possiblybyreducingimmunityand thereforeresistancetoTBinfection.Anotherfactorthatincreasesthepotentialforharmfrom TBisthepresenceofstrainsofTBthatareresistanttomultipleantitubercularantibiotics.Since 1993,whentheTBsurveillancesystemwasexpandedtoincludedrug-susceptibilityresults, reportedmultidrug-resistant(MDR)TBcaseshavedecreasedintheUnitedStates.AmongTB casesintheUnitedStateswithinitialdrug-susceptibilitytestingresultswhodidnothaveprior treatment,thepercentageofprimaryMDRTBcaseschangedslightlyfrom1.2%(86cases)in 2012to1.4%(95cases)in2013.(42) WhilemoststrainsofM.tuberculosiscanbetreatedbyantitubercularantibiotics,the treatmenttakesninemonthstocomplete,andintheeventthestrainofM.tuberculosis involvedisdrugresistant,treatmentmaybedifficultandtakelonger.Aswiththevirally mediateddiseasesdiscussedpreviously,TBismosteffectivelymanagedbypreventing infection.PreventingthetransmissionofTBisdonebythefollowing: 1. Healthcareworkers(HCWs)includingacupuncturistsshouldhaveanannualskintestfor TB.Thistestshouldberepeatedaftertwoweeksiftheprevioustestwasnotwithinone year.Analternativetest,theQuantiFERONbloodtestisnowapprovedforTBtesting. Thistesthastheadvantagethatonlyonecontactisrequired,resultsareavailablemore rapidly,andisnotimpactedbypriorBCG(bacilliCalmette-Guerin)vaccination. 2. IndividualswhowerevaccinatedforTBorhaveahistoryofapositiveskintestshould getachestx-rayandanannualphysicalexamination. 3. Ifapatientpresentsinyourclinicwithachroniccoughofunknownorigin,thepatient shouldbeaskedtowearamask.Itisagoodpolicytohavemasksavailableforany patientwithacoughofunknownorigintopreventtransmissionofairbornepathogens, includingTB. 4. IfyoususpectyourpatientmayhaveTB,thepatientmustbereferredtoaphysicianfor diagnosisandtreatment. Anumberofsmallstudieshavebeencompletedlookingattheeffectsofacupunctureand moxibustiononthetreatmentorsymptomsoftuberculosis,oftenwithgoodresults.While therearenoreportsoftuberculosistransmissioninalicensedpractitioner’spracticelocation, thereisonecaseoftuberculosisbeingcausedbyanillegalacupuncturist,(43)highlightingthe needtounderstandandidentifythisdisease. TransmissionofMycobacteriumtuberculosisisarecognizedrisktopatientsandhealthcare personnelinhealthcarefacilities.Transmissionismostlikelytooccurfrompatientswhohave 150 unrecognizedpulmonarytuberculosisortuberculosisrelatedtotheirlarynx,arenoton effectiveanti-tuberculosistherapy,andhavenotbeenplacedintuberculosisisolation. TransmissionofMycobacteriumtuberculosisinhealthcaresettingshasbeenassociatedwith closecontactwithpersonswhohaveinfectioustuberculosis.(44) TB Survival Outside Host M.tuberculosiscansurviveformonthsondryinanimatesurfacesandcansurviveinsoilfor4 weeks,andintheenvironmentformorethan74days.Exposuretolightinactivatesthe bacterium.(45) Acupuncture TB Safety Ultimatelythemostimportantcomponentinaclinicalsafetyprogramissafepracticeonthe partofthepractitioner.Thesafeuseofsharps,preventionoftransmissionofbloodborne pathogens,andotherappropriateriskmanagementtechniquespreventharmtothe practitioner,hisorherfamilymembers,andthepublic.Utilizingrespiratoryetiquetteand StandardPracticeswilllimitexposureofthepractitionerandpatientstoTB.Safepractice remainsthemostimportantobligationfortheacupuncturist.CleanNeedleTechniqueand StandardPracticesareavitalpartofsafepracticefortheacupuncturist. Skin Infections Prospectiveandretrospectivestudiesofacupuncturesafetypointtoasmallnumberof localizedskininfectionsoccurringasaresultofacupuncture.(1) CommonresidentbacteriaoftheskinincludeStaphylococcusandStreptococcusspecies. Impetigoandotherlocalskininfectionscanoccurwhenabreakintheskinallowsthestaphor streptoenterthedermisorlowerstructures.(46) Staphylococcus Staphylococcusspeciesaregram–positivebacterianormallyfoundontheskin.“Staph” bacteria,suchasStaphylococcusepidermidisorStaphylococcusaureus,arecommonbacterial contaminantsfoundontheskinthatcanenterthebodyofapractitionerorpatient.Thistypeof contaminationisthoughttooccurwhenthebacteriaontheskinispassedintothebody throughinsertionofaneedleintotheskin.(47) Skininfectionscausedbystaphareusuallyredandpainful.Somestartaspainfulbumpsthat seemlikespiderbites,butquicklybecomeabscesses(boils)filledwithpus.(48) Staphylococcusaureusaccountsformorethanhalfofthereportedcasesofacupuncturerelatedbacterialinfectionsoftheskin.(49) 151 Individualcasereportsofstaphinfectionsafteracupunctureincludecasesofpericardial abscess,(50)necrotizingfasciitis,(51)bacteremia,(52)andspinalsubduralempyema.(53) PreventingStaphylococcusinfectionsinvolvesstandardpracticesofhandwashingandavoiding needlingorotherproceduresinareaswithactiveskinlesions. Methicillin-Resistant Staphylococcus Aureus (MRSA) ThebacteriumStaphylococcusaureusisagrampositive,coagulasepositiveaerobiccoccus associatedwithwoundinfectionsandothermedicallysignificantinfections.Onestrainofstaph aureus,resistanttotheantibioticmethicillin(methicillin-resistantStaphylococcusaureus, MRSA)hasbecomeasignificantsourceofantibioticresistantinfections.(54,55)Thisorganism isspreadbyskin-to-skincontactandcanbereadilytransmittedfrompatientstohealthcare providers,staffandotherpatients.Between25%and30%ofthepopulationmaybecarriersof MRSA.(55)WhilethemajorityofMRSAinfectionsappeartobenosocomial(infectionsacquired fromthehealthcaresetting),12%arecommunity-acquired.(55) Prevention ItisimperativetopreventthespreadofMRSAtopatientsandco-workers.Appropriate preventionstrategiesincludethefollowing:(56,57) 1. Appropriatehandwashingandtheuseofhandcleansers. 2. Theuseofbarrierprotectionsuchasgloves,labcoatsorgowns,andfacemasksas necessary. 3. Properhandlingofpotentiallycontaminatedmaterialssuchassharps,disposable suppliessuchascottonandgauze,andsoiledorblood-stainedlinen. 4. Avoidcontactwithdrainingwounds,pimple-likelesions,orotherskinlesionsthatmay beasiteofinfection. 5. AvoidacupunctureandotherAOMtechniquesininflamedorinfectedskinregions. 6. UseofCleanNeedleTechnique. 7. Scrupuloususeoftheappropriatedisinfectants. 8. Referralofpatientsthatmaybeinfectedtoaphysicianforappropriatetreatment. MRSAhasbeenreportedafteracupuncturetreatmentsandmaycausesignificantdamage.(2, 58)InonecasestudythetransmissionofMRSAwasclearlyfromthemedicalpractitionertothe patients.(59)Therearesignificantrisksassociatedwithtreatingapatientthathaslesions consistentwithMRSA,includingdrainingwounds,suppuratinglesions,orpustulesthathave notbeenassessedbyaphysician.Therearealsorisksassociatedwithtreatingpatientswhen thepractitionercurrentlyhasactiveskinlesionsthathavenotbeenassessedbyamedical professional.Itisimperativethatanassessmentofanyactiveskinlesionsineitherapatientor 152 practitionerbemadeassoonaspossible.ItisappropriatetodelayAOMtreatmentuntilsuch anassessmentismadeandappropriateantibiotictherapyinitiated. MRSA Survival in the Environment MoststudiessuggestthatMRSAcanliveupto90daysoninanimateobjectsanddrysurfaces. MRSAbacteriacanremainviableonsurfaceslongerthanotherbacteriaandvirusesbecause theycansurvivewithoutmoisture.(24)MRSAcansurvivelongeronhardsurfacesthansoft surfacesbutcanbeinactivatedusingappropriateEPA-approveddisinfectingsolutions. Streptococcus GroupAStreptococcus(GAS)isabacteriumoftenfoundinthethroatandontheskin.GAS diseasemayoccurwhenbacteriafromthethroatorskinenterspartsofthebodywhere bacteriausuallyarenotfound,suchassubcutaneoustissues,theblood,orthelungs.These bacteriaarespreadthroughdirectcontactwithmucusfromthenoseorthroatofpersonswho areinfectedorthroughcontactwithinfectedwoundsorsoresontheskin.(60) StrepAmaycauseaskininfectionsuchasimpetigoorotherskininfections.Pyogenicskin infectionsassociatedwithacupuncturemaybeStreptococcalinfections.Whilerare (approximately50casesreportedgloballyinthe1970sand1980s)(61)Streptococcalinfections mayoccurasaresultofacupuncture. PreventingStreptococcalinfectionsinvolvesstandardpracticesofhandwashing,Standard Practicesandavoidingneedlingorotherproceduresinareaswithactiveskinlesions.(62) Mycobacteria Other than Tuberculosis (MOT) (Mycobacteriumabscessus,Mycobacteriumfortuitum,Mycobacteriumhaemophilum) Mycobacteriumabscessuscanbefoundinwater,soil,anddust.Ithasbeenknownto contaminatemedicationsandproducts,includingmedicaldevices.HealthcareassociatedMycobacteriumabscessuscancauseinfectionsoftheskinandthesofttissuesunder theskin.Itcanalsocauselunginfectionsinpersonswithvariouschroniclungdiseases.(61) Mycobacteriaotherthantuberculosis(MOT)areofspecialsignificancetotheacupuncturist becauseofanumberofreportsofAOM-associatedskinlesionscausedbyMOT.MOT-related skindiseaseshavebeenreportedinoutbreaksassociatedwithspecificacupunctureclinicsin CanadaandKorea.(2)TherecognitionandmanagementofMOTdiseasesareinthedomainof thedermatologist.(63)MOTareslow-growingbacteriathatcancausediseaseinboth immunocompetentandimmunocompromisedpatients.Themostcommonclinical presentationsofinfectionaretheappearanceofsuppurativeandulceratedskinnodules.(64) 153 MOTarewidelydistributedintheenvironment,particularlyinwetsoil,marshland,streams, riversandestuaries.(65)MOTaregenerallyfoundintheenvironmentasfree-livingorganisms andthereforemaypersistinwetordryenvironmentsforasignificantperiodoftime. Mycobacterium(MOT)infectionshavebeenreportedasrelatedtoacupuncture“probably associatedwiththeinadequatesterilizationoftheneedlesorthepuncturesite.”(66) Mycobacteriuminfectionsareprobablynotassociatedwithacupuncturewhenthepractitioner followsallcriticalcomponentsoftheCNTprotocols.However,anumberofcaseshavebeen discussedintheliterature.(2,66-70)Itislikelythatsomeoftheseinfectionsassociatedwith acupuncturearearesultofdirtcarriedinbypatientsandthenleftbehindontowelsusedfor hotpacks,treatmenttablelinensandothercloththathasnotbeenchangedbetweeneachand everypatientvisit. PreventingMycobacteriumotherthanTuberculosis(MOT)intheclinic: 1. Appropriatehandwashingandtheuseofalcohol-basedhandcleansers. 2. ScrupuloususeofCNTprocedures. 3. Properhandlingofpotentiallycontaminatedmaterialssuchassharps,anddisposable suppliessuchascottonandgauze. 4. Scrupuloususeoftheappropriatedisinfectantsforthetreatmentroomandtreatment tables. 5. Meticulousreplacementofanysheetsortowelsbetweeneachandeverypatientvisit. 6. Referralofpatientsthatmaybeinfectedtoaphysicianforappropriatetreatment. Herpes Simplex Twoserotypesofherpessimplexvirus(HSV)havebeenidentified:HSV-1andHSV-2.HSV-1is usuallyassociatedwithorallesions(i.e.,coldsores),althoughbothHSV-1andHSV-2maybe foundinoralorgenitalmucosallesions.HSV-1istypicallytransmittedbysalivaorbythe infectiononhandsofhealthcarepersonnel.(70)HSVcanbetransmittedbydirectcontactwith epithelialormucosalsurfaces.HSVcanbetransmittedbyingestion,parenteralinjection, dropletexposureofthemucousmembranes(eyes,noseormouth),andinhalationof aerosolizedmaterials.(70,71) BothformsofHSVarecharacterizedbyrecurringlesions.Aftertheinitialinfection,whichis oftenthemostsevereoutbreak,theviruswillgointoquiescenceforvaryinglengthsoftime. Thenextstageisaprodromalstage,whichmayincludelocalizeditching,painortinglingatthe siteoftheinfection.Atthispoint,thevirusisbeingshedandotherscanbecomeinfected.The laststageiscalledanoutbreak.Outbreaksarecharacterizedbythesamesymptomsinthe samelocationastheinitialattack,buttendtowardbecomingmilderovertime.Ifblistersform, 154 theywilltypicallyhealin7-10days.ThepersonwithHSVisstillsheddingvirusatthispointand canspreadtheinfectionthroughtouch.TheHSVviralcyclewillthenstartagain. Acupuncture,moxibustion,cuppingandotherAOMprocedureshavebeenassociatedwith decreasingthepainandimprovinghealthofthosewithherpes-relatedlesions.(72-74) AcupunctureandcuppingmayalsobeassociatedwithspreadingtheHSVifStandard Precautionsarenottaken.(75) TopreventtransmissionoftheHSVvirus,StandardPrecautionsshouldbefollowed. Practitionersshouldrefrainfromtouchingactivelesionsandavoidtreatmentproceduresinthe areaofanylesions.Sincepatients’handscontactpracticelocationsurfaces,andtheviruscould reachanobjectthatistouchedbyanotherperson,allsurfacesmustbedisinfecteddaily.(76, 77)TheHSV1andHSV2viruscansurviveforseveralhoursonworksurfaces,suchastreatment tablesandcountertops.(76) Influenza Influenzaisprimarilyacommunity-basedinfectionthatistransmittedinhouseholdsand communitysettings,includinghealthcareclinics. Healthcare-associatedinfluenzainfectionscanoccurinanyhealthcaresettingandaremost commonwheninfluenzaisalsocirculatinginthecommunity.Therefore,infectioncontrol measuresneedtobeutilizedinallacupuncturepracticelocationstoreducetransmissionofthe influenzavirus.(78) Formoreinformationvisit: InfectionControlinhealthcareFacilities (http://www.cdc.gov/flu/professionals/infectioncontrol/index.htm) Influenza Survival in the Environment Influenzavirusescansurviveintheenvironmentforupto24hours.(79)Propercleaningis requiredtopreventtransferfromtreatmentsurfacestopatients,staffandfamilymembers. Acupuncturecanbeeffectiveintreatingorhelpingpreventupperrespiratoryinfections.(80, 81)However,havingpatientsacutelyillinahealthcaresettingincreasestheriskoftransmission ofthevirustohealthcareworkersandotherpatients.StandardPrecautionsneedtobe followedintermsofhandwashingandtreatmentroomdisinfection. 155 CDC Fundamental Elements to Prevent Influenza Transmission Preventingtransmissionofinfluenzavirusandotherinfectiousagentswithinhealthcare settingsrequiresamulti-facetedapproach.Spreadofinfluenzaviruscanoccuramongpatients, healthcareworkers,officestaff,andvisitors.Thecorepreventionstrategiesinclude:(78) InfluenzavaccinationofHCWsandat-riskpublicannually. Implementationofrespiratoryhygieneandcoughetiquette. ImplementationofStandardPrecautions. Adherencetoinfectioncontrolprecautionsforallpatient-careactivitiesandaerosolgeneratingprocedures. Implementingenvironmentalandengineeringinfectioncontrolmeasures. • • • • • Healthcareworkersmuststayhomewhenacutelyill.Inmostcases,personnelshouldnotbe activelyseeingpatientsuntilfreeoffeverforatleast24hourswithouttheuseofNSAIDs. Norovirus Norovirusesareagroupofvirusesthatcausegastroenteritis,causinganacuteonsetofsevere vomitinganddiarrhea.Thisvirusisverycontagiousandcanspreadrapidlythroughout healthcarefacilities.(82)Peoplecanbecomeinfectedwiththevirusinseveralways: • Havingdirectcontactwithanotherpersonwhoisinfected(ahealthcareworker, visitor,oranotherpatient). • Eatingfoodordrinkingliquidsthatarecontaminatedwithnorovirus. • Touchingsurfacesorobjectscontaminatedwithnorovirus,andthentouchingyour mouthorotherfooditems. Norovirusistransmittedbyhandscontaminatedthroughthefecal-oralroute,directlyfrom persontoperson,throughcontaminatedfoodorwater,orbycontactwithcontaminated surfaces.(83)Thenorovirusisrelativelystableintheenvironmentandcanpersistforweekson hardsurfaces. NoroviruseshavenotbeenlinkedtoacupunctureorrelatedAOMproceduresinthemedical literature.Estimatesare19-21millioncasesofnorovirusarereportedintheU.S.eachyear.(84) AsnorovirusdiseasesareoneofthemostcommoninfectionsintheU.S.,allhealthcare practitionersneedtofollowStandardPrecautionstopreventthespreadofthishighly contagiousorganism. Prevention of Norovirus Thecorepreventionstrategiesinclude:(83) 156 • • • • • Followhand-hygieneguidelines,andcarefullywashhandswithsoapandwaterafter contactwithpatientswithnorovirusinfection. Usegownsandgloveswhenincontactwith,orcaringforpatientswhoaresymptomatic withnorovirus. Routinelycleananddisinfecthightouchpatientsurfacesandequipmentwithan EnvironmentalProtectionAgency-approvedproductwithalabelclaimfornorovirus. Removeandwashcontaminatedclothingorlinens. Healthcareworkerswhohavesymptomsconsistentwithnorovirusshouldbeexcluded fromworkforatleast3daysaftersymptomsresolve. Appropriatehandhygieneislikelythesinglemostimportantmethodtopreventnorovirus infectionandcontroltransmission.Reducinganynoroviruspresentonhandsisbest accomplishedbythoroughhandwashingwithrunningwaterandantisepticsoap.Alcohol-based handsanitizersdonotdemonstrateefficacyagainstthenorovirus.(84,85)Healthcareworkers shouldstayawayfromworkwhileillandforatleast48to72hoursfollowingresolutionof symptoms.(83) Clostridium difficile Clostridiumdifficileisaspore-forming,gram-positiveanaerobicbacillusthatproducestwo exotoxins:toxinAandtoxinB.Itisacommoncauseofantibiotic-associateddiarrhea(AAD).It accountsfor15-25%ofallepisodesofAAD.(86) NearlyallantimicrobialshavebeenimplicatedinthedevelopmentofClostridiumdifficile associateddisease(CDAD).Personswithnormalhealthygastrointestinalfloraandtheabilityto mountabriskimmuneresponseareatlowerriskforCDAD.(87) ClinicalsymptomsofClostridiumdifficileincludewaterydiarrhea,fever,lossofappetite, nausea,andabdominalpainandtenderness. Clostridiumdifficileisshedinfeces.Anysurface,device,ormaterial(e.g.,commodes,rectal thermometers)thatbecomescontaminatedwithfecesmayserveasareservoirfor theClostridiumdifficilespores.Clostridiumdifficilesporesaretransferredtopatientsmainlyvia thehandsofhealthcarepersonnelwhohavetouchedacontaminatedsurfaceoritem.(86) ThetwoprimaryagentsusedtotreatCDADaremetronidazoleandoralvancomycin.Adjunctive therapiesforrefractorydiseaseincludeeffortstoreplenishcolonicflorawiththeuseoforally administeredprobiotics,usuallyLactobacillusspeciesorSaccharomycesboulardii.(87) Clostridiumdifficilesporesresistkillingbyusualhospitaldisinfectantsandmaysurviveon surfacesforuptofivemonths.(88)Specialproceduresneedtobefollowedwhencaringfor patientswithClostridiumdifficile–associateddisease. 157 Prevention of Spread of Clostridium difficile CDCrecommendationstopreventtransmissionofClostridiumdifficileinpractitioners’offices: (86) Usegloveswhenenteringpatients’roomsandduringpatientcarewhenthepatientisa knowncarrierofClostridiumdifficile. • Performhandhygieneafterremovinggloves. o BecausealcoholdoesnotkillClostridiumdifficilespores,useofsoapandwateris moreefficaciousthanalcohol-basedhandsanitizers.However,early experimentaldatasuggestthat,evenusingsoapandwater,theremoval ofClostridiumdifficilesporesismorechallengingthantheremovalor inactivationofothercommonpathogens. o Preventingcontaminationofthehandsviagloveuseremainsthecornerstonefor preventingClostridiumdifficiletransmissionviathehandsofhealthcareworkers; anytheoreticalbenefitfrominstitutingsoapandwatermustbebalancedagainst thepotentialfordecreasedcomplianceresultingfromamorecomplexhand hygienemessage. o Ifyourinstitutionorclinicexperiencesanoutbreak,considerusingonlysoapand waterforhandhygienewhencaringforpatientswithClostridium difficileinfection • Usegownswhenenteringpatients’roomsandduringpatientcarewhenthepatientisa knowncarrierofClostridiumdifficile. • Dedicateorperformcleaningofanysharedmedicalequipmentfromatreatmentroom whenthepatientisaknowncarrierofClostridiumdifficile. Implementanenvironmentalcleaninganddisinfectionstrategywhenthepatientisaknown carrierofClostridiumdifficile: • • • Ensureadequatecleaninganddisinfectionofenvironmentalsurfacesandreusable devices,especiallyitemslikelytobecontaminatedwithfecesandsurfacesthatare touchedfrequently. ConsiderusinganEnvironmentalProtectionAgency(EPA)-registereddisinfectantwitha sporicidalclaimforenvironmentalsurfacedisinfectionaftercleaninginaccordancewith labelinstructions.Hypochlorite-baseddisinfectantsmaybemosteffectivein preventingClostridiumdifficiletransmission. 158 5. Summary of Prevention of Disease Transmission in Acupuncture Practice Basic Critical Principles • • • • • • • FollowCleanNeedleTechniqueforacupunctureandrelatedAOMprocedures. Useonlysingle-usesterilefiliformneedles. Usesingle-usesteriledevicesthatentertheskin,includinglancetsandseven-star hammers. Cleanhandsimmediatelybeforeanyclinicalprocedure,includinginsertingneedles, betweenpatientvisits,aftercontactwithanybodilyfluidsorOPIM. Alwaysestablishacleanfieldensuringthecleanlinessofthepractitioner’sandpatient’s skinandthesterilityoftheshaftoftheneedleandothermedicaldevices. Immediatelyisolateusedneedlesandothersharpsinanappropriatesharpscontainer. Donotneedleorotherwisetreatareasoftheskinwithactivelesions. Preventing Patient to Patient Cross Infections – Critical Recommendations • • • • Usesingle-usesterileneedlesandotherdevicesthatentertheskin,including acupunctureneedles,lancets,andseven-starhammers. Utilizeproperhandwashingtechniquesbetweenpatientvisits. Instituteandfollowproceduresforpropercleaningofthetreatmenttableand treatmentroom. Casualcontactsbetweenpatientsorbetweenpatientsandthepractitionersuchas contactwithclothingetc.arenotcauseforconcern.However,itisstrongly recommendedthatpoliciesbeputinplacetolimitthecontactbetweenpatientsifa patientisdisplayingsymptomsofactiveacuteinfections. Preventing Patient to Practitioner Cross Infections • • • • • Avoidtouchingtheshaftortipofausedneedleorotherusedhealthcaresharp. Alwaysimmediatelyisolateusedsharpsinpropercontainers. Useadrycottonballorgauzetoclosethepoint.Neverusethebarefingertocoverthe skinwhereaneedlehasbeenremoved. Keepallskinbreaksonthepractitioner’shandscovered. ConsidervaccinationagainstHepatitisB. Preventing Practitioner to Patient Cross Infections • • Handwashingiscritical. Avoidtouchingtheshaftofaneedlethatwillpenetratethepatient’sskinpriorto insertion. 159 • • • Avoidallpatientcontactifyouhaveanovertclinicalinfection.Donottreatpatientsif youhaveafeverand/orproductivecough. Keepallopencuts,woundsorotherlesionsonyourskincovered. HaveayearlyphysicalwithappropriatetestingasdescribedbyOSHA/CDC. Review Whileitisimpossibletoavoidallinfectionsinahealthcareworkplace,thereareanumberof criticalfactorsinlimitinginfectionstotherareoccurrencestheyhavebeenshowntobein prospectivestudies.Thesepracticesare: • • • • • • Ensuringthehandsofthepractitionerarecleanthroughhandwashing. Properpreparationoftheneedlingsites,includingavoidingneedlingskinwithactive lesionsandproperskinpreparation. Utilizingsterileneedlesandotherdevicesthatentertheskin,andtheirproperstorage. CleanNeedleTechnique. Carefulmanagementanddisposalofusedneedlesandotherequipment. Acleanworkingenvironment. 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AccessedMarch2013. 87.GouldCarolynandLCliffordMcDonald.Bench-to-bedsidereview:Clostridiumdifficile colitis.CriticalCare2008,12:203,http://ccforum.com/content/12/1/203.Accessed March2013 88.CentersforDiseaseControlandPrevention.PreventingClostridiumdifficileInfections http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6109a3.htm?s_cid=mm6109a3_w. March9,2012/61(09);157-162.AccessedMarch2013. 167 Part V: Personnel Health, Cleanliness and Safety Practices Thissectionaddressesthepracticestoreducetransmissionofdiseasesthroughhygienic methods.Sincetherearenostudiesofhandwashing,skinpreparation,andgloveuse specificallyinacupuncturepractices,generalhealthcarestandards(CDC,WHO)aretheprimary resourcesforrecommendationsinthissection. 1. Handwashing Themostcommonmodeofhealthcare-associatedinfectiontransmissionisvia thehands! Pleasenote:boththeCDCandWorldHealthOrganizationhavepublishedextensiveinformation abouthandwashingtechniquesandbestpractices.Whatispresentedhereisjustanoverview. Forthoseinterestedinreadingmoresee: • • • • http://www.cdc.gov/handhygiene/download/hand_hygiene_core.pdf http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf http://www.jointcommission.org/assets/1/18/hh_monograph.pdf http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm Itisstronglyrecommendedthatacupuncturistsalwayswashtheirhands: 1. Immediatelybeforeacupunctureorotherclinicalprocedures. 2. Aftercontactwithbloodorbodyfluidsorobviousenvironmentalcontaminants. 3. Attheendofatreatment. AHistoryofHandwashingforHealthcareWorkers(HCWs): LouisPasteurdemonstratedinthe1860sthatmicrobescauseddiseases.Inthemid-1800s, IgnazSemmelweisinVienna,Austria,andOliverWendellHolmesinBoston,U.S.,established thathospital-acquireddiseasesweretransmittedviathehandsofHCWs.(1)ThefirstU.S. nationalhandhygieneguidelineswerepublishedinthe1980s.In1995and1996,the CDC/HealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC)intheU.S. recommendedthateithersoapandwaterorawaterlessantisepticagentbeusedforcleansing handsuponleavingtheroomsofpatients. ImportanceofHandwashing: Thehandsofhealthcareworkers(HCWs)arethemainsourceofhospitalinfection,and thereforehandwashingisthemostimportantprocedureforpreventingnosocomialinfections. 168 Cleanhandsarethesinglemostimportantfactorinpreventingthespreadofpathogensand antibioticresistanceinhealthcaresettings.(2)Goodhandhygienereducestheincidenceof healthcare-associatedinfections. Healthcarespecialistsgenerallycitehandwashingasthesinglemosteffectivewaytoprevent thetransmissionofdisease.(3)Hygienichandcleaningbyhospitalpersonneltoremovethe transientbacteriawhichcontaminatesthehandsandskinofHCWsiscriticalforinfection controlinallhealthcaresettings.(4-6) Despiteevidencefortheimportanceofhandwashinginthepreventionofnosocomialinfection, studieshavedemonstratedthatcompliancewiththerecommendationthatHCWswashtheir handsbetweeneachandeverypatientvisitremainslowinpatientcaresettings.(7) Effective Handwashing Technique Handwashingwithsoapandrunningwateristhemosteffectiveformofhandwashing. However,whenthereisnosinkavailable,practitionersmayuseanalcohol-basedhand sanitizer.Analcohol-basedhandsanitizercanenhancekillingoftransienthandflorawithout theuseofrunningwater,soap,andhanddrying,butcannotreplacehandwashingforremoving allhandcontaminants. Duration-SoapandWater: Althoughthereisnoacceptedoptimallengthoftimeforhandwashing,anumberofstudies havelookedat15-secondprotocolsforhandcleansing.(8-14)Unfortunately,mostHCWs generallywashtheirhandsformuchshorterdurations,sotheeffectivenessofhandwashingas actuallypracticedhasnotreallybeenstudied. Soapsaredetergent-basedproductswhosecleaningactivitycanbeattributedtotheir detergentproperties,whichresultinremovalofdirt,soil,andvariousorganicsubstances, includingpathogens,fromthehands.Plainsoapshaveminimal,ifany,directantimicrobial activity.(1)Handwashingwithplainsoapcananddoesremovelooselyadherenttransientflora. However,inseveralstudies,handwashingwithplainsoapfailedtoremovepathogensfromthe handsofhospitalpersonnel.(14,15)Handwashingwithplainsoapandwaterdoesdecreasethe transmissionofHAI.Therefore,whilethebestpracticeinhandwashingremainsunclearwhatis clearisthatsoapandwatershouldbeutilizedasindicatedbyStandardPractices. Hand Hygiene Technique: Soap and Water Whenwashinghandswithsoapandwater:(16,17) • • Removealljewelryandrollupthesleevesofyourshirt,ifnecessary. Wethandsfirstwithcooltowarmwater. 169 • • • • • Applyanamountofantibacterialsoaprecommendedbythemanufacturertohands. Rubhandstogethervigorouslyfor10-20seconds,coveringallsurfacesofthehandsand fingers. Rinsehandswellwithrunningwater. Drythoroughlywithaclean,disposabletowel. Usetoweltoturnoffthefaucetusingthedisposabletowel,notyourcleanhands. Avoidusinghotwater,becauserepeatedexposuretohotwatermayincreasetheriskof dermatitis.(18,19) Hand Drying Becausewethandscanmorereadilyacquireandspreadmicroorganisms,theproperdryingof handsisanintegralpartofroutinehandwashing.Carefulhanddryingisacriticalfactor determiningthelevelofbacterialtransferassociatedwithtouchcontactafterhandcleansing. Reusingorsharingtowelsshouldbeavoidedbecauseoftheriskofcross-infection.Reusable clothtowelsorroll-typetowelsarenotrecommendedforuseinhealthcaresettings.Instead, alwaysusepapertowelsforhanddrying.(20,21)Inacomparisonofmethodstotestthe efficiencyofhanddryingfortheremovalofbacteriafromwashedhands,warmairdrying performedworsethandryingwithpapertowels.(22)Whencleanordisposabletowelsare used,itisimportanttopattheskinratherthanrubit,toavoidskincracking.Skinexcoriation mayleadtobacteriacolonizingtheskinandpossiblespreadofbloodbornevirusesaswellas othermicroorganisms.(23)Usepapertowelstoturnofffaucetsandtoopendoorsbetweenthe handwashingstationandthepatientcareroom. Hand Hygiene Technique - Alcohol-Based Sanitizers Whendecontaminatinghandswithanalcohol-basedhandsanitizer,applyproducttopalmof onehandandrubhandstogether,coveringallsurfacesofhandsandfingers,untilhandsare dry.(24,25)Followthemanufacturer’srecommendationsregardingthevolumeofproductto use.Inhealthcarepractices,alwaysusedapprovedproductsforhandcleansing;“home remedies”suchasvariouscombinationsofessentialoilsandlotionsmaynotreducetransient bacterialloadsignificantly. Handwashing - Antiseptic Towelettes Antimicrobial-impregnatedwipes(i.e.,towelettes)maybeconsideredasanalternativeto washinghandswithsoapandwaterevenwhenthehandsarevisiblysoiled.(12)However,the useofsoapandwaterisstillconsideredthebestmethodforcleaninghandsthathavebeen soiledwithbloodandOPIM,afterremovalofgloves,afterusingtherestroomandbeforeand aftereating. 170 Hand Flora Therearetwotypesofinfectiousagentsontheskin:residentandtransient.In1938,Price(26) establishedthatbacteriarecoveredfromthehandscouldbedividedintothesetwocategories. ResidentHandFlora:Theresidentfloraoftheskinconsistsofmicroorganismsresidingunder thesuperficialcellsofthestratumcorneumandcanalsobefoundonthesurfaceofthe skin.(27,28)Staphylococcusepidermidisisthedominantspecies.(29)Otherresidentbacteria includeS.hominisandotherstaphylococci,followedbycoryneformbacteriaandotherbacteria. (30)Residentflorahastwomainprotectivefunctions:itpreventscolonizationoftheskinby pathogenicorganismsandcompeteswithanyorganismsfornutrients,thuspreventing permanentassociationwiththoseorganisms.(31)Ingeneral,residentfloraislesslikelytobe associatedwithhealthcareassociatedinfections,butmaycauseinfectionsinsterilebody cavities,theeyes,oronnon-intactskin.(32) Transientskinflora:Transientortemporaryskinflorareferstothemicroorganismsthat transientlycolonizetheskin.Thisincludesbacteria,fungiandviruses,whichreachthehands, forexample,bydirectskin-to-skincontactorindirectlyviatouchingsurfacesofdesks,light switches,utensils,andotherobjects.Handwashingisaimedatreducingoreliminatingtransient pathogenicskinflora.(33) Rings/Jewelry Severalstudieshavedemonstratedthatskinunderneathringsismoreheavilycolonizedthan comparableareasofskinonfingerswithoutrings.Onestudyfoundthat40%ofnurses harboredgram-negativebacilli(e.g.,E.cloacae,Klebsiella,andAcinetobacter)onskinunder ringsandthatcertainnursescarriedthesameorganismundertheirringsforseveralmonths. (34-36) Healthcare workers and Actual Handwashing Practices Unfortunately,manyHCWsdonotwashtheirhandsasoftenasisrecommendedforbeingina healthcarepractice.(37)Studieshaveconsistentlydemonstratedratesofhandwashing compliancearelessthan50%inmanyhospitals. Necessity of Handwashing Thenecessityofhandwashingbetweenpatients/patientvisitsandtheuseofStandard Precautionsreflectstheimportanceoftreatingallpatientsasiftheywerecarriersofhepatitis orHIV.Beyondthis,theneedtowashthehandsisbasedonwhetherthehandsbecome contaminatedduringthecourseoftreatment.Practitionersmustwashtheirhandsbetween patients,beforeandafterinsertingneedles,andaftercontactwithpotentiallyinfectiousbody fluids. 171 Sourcesofcontaminationincludebodyfluidssuchasbloodandsaliva,vaginalsecretions,and fecalcontamination,andfluidsfromopenlesions.Bodyfluidsmaycontainbacteriasuchas Staphylococcusspecies,andvirusesassociatedwithhepatitisandHIV/AIDS.Itisabsolutely imperativethatpotentiallyinfectiousfluidsnotbetransferredfromonepersontoanother throughtheacupunctureprovider’shands,orfromthepatienttothepractitionerand/orother membersoftheclinicstaff.Thisismosteffectivelydonebycarefullywashinghandswhenever needed.Handwashingshouldalsotakeplacebeforeandafteransweringthephone,whenever thepractitionertoucheshisorherfaceorhair,eats,orengagesinanyothernon-clinical activity. What is the right way to wash your hands? • • • • • • • Removealljewelryandrollupthesleevesofyourshirt,ifnecessary. Wethandsfirstwithcooltowarmwater. Applyanamountofsoap(plainorantibacterial)recommendedbythemanufacturerto hands. Rubhandstogethervigorouslyfor10-15seconds,coveringallsurfacesofthehandsand fingers. Rinsehandswellwithrunningwater. Drythoroughlywithaclean,disposabletowel. Useadisposabletoweltoturnoffthefaucet,notyourcleanhands TheCDCrecommendsspecifictypesofhandwashingunderthefollowingcircumstances:(2) 1. Whenhandsarevisiblydirtyorarevisiblysoiledwithbloodorotherbodyfluids,wash handswithsoapandwater. 2. Ifhandsarenotvisiblysoiled,practitionersmayuseeitheranalcohol-basedhand sanitizer,orsoapandwaterforroutinelydecontaminatinghandsinclinicalsituations. 3. Decontaminatehandsbeforehavingdirectcontactwithpatients. 4. Decontaminatehandsaftercontactwithapatient'sintactskin(e.g.,whentakingapulse orbloodpressure,orpalpatingpoints). 5. Decontaminatehandsaftercontactwithbodyfluidsorexcretions,mucousmembranes, nonintactskin,andwounddressingsevenifhandsarenotvisiblysoiled. 6. Decontaminatehandsifmovingfromacontaminated-bodysitetoaclean-bodysite duringpatientcare. 7. Decontaminatehandsafterremovinggloveswithsoapandwater. 8. Beforeeatingandafterusingarestroom,washhandswithsoapandwater. 9. Antimicrobial-impregnatedwipes(i.e.,towelettes)maybeconsideredasanalternative towashinghandswithsoapandwater. 172 Handwashingwithsoapandrunningwateristhemosteffectiveformofhandwashing. However,whenthereisnosinkavailable,practitionersmayuseanalcohol-basedhand sanitizer.Analcohol-basedhandsanitizercande-germhandsinlessthan30secondsand enhancekillingoftransienthandflorawithouttheuseofrunningwater,soap,andhanddrying. Studieshaveshownthatcliniciansfindalcohol-basedhandsanitizersconvenient,accessible, andlessirritatingtotheskin.(38)TheCDChasalsoacceptedtheuseofantiseptichand cleansersortowelettesexceptwhencircumstancesrequiretheuseofsoapandwater.(39) ThenecessityofhandwashingbetweenpatientsandtheuseofStandardPrecautionsreflects theimportanceoftreatingallpatientsasiftheywerecarriersofhepatitisorHIV.Beyondthis, theneedtowashthehandsisbasedonwhetherthehandsbecomecontaminatedduringthe courseoftreatment.Practitionersmustwashtheirhandsbetweenpatients,beforeandafter insertingneedles,beforeandafterotherclinicalprocedures,andaftercontactwithpotentially infectiousbodyfluids. Recommendations • • • • • • • • • Critical:Washhandsbetweeneverypatientvisit. Critical:Washhandsimmediatelypriortoinsertingacupunctureneedlesorperforming otherproceduresthatbreaktheskin. Critical:Washhandsafterenteringtheclinicandbeforestartinganypatientcare. Critical:Washhandsbeforeandaftereating. Critical:Washhandswithsoapandwaterafterusingtherestroom. Critical:Washhandsafterremovinggloves. StronglyRecommended:Washhandsbeforeperforminganyclinicalprocedure, includingthosethatdonotbreaktheskin(e.g.,cupping). StronglyRecommended:Washhandsaftertakingapatient’spulseandafterpalpating points. Recommended:Washhandsafterdecontaminatingreusableequipment. 2. Patient Skin Preparation Therearenoprospectivestudiesdemonstratingeithertheneedfororlackofneedforskin preparationbeforeacupunctureandotherAOMpractices.Thebestevidenceisthathavingthe patient’sskinbecleanandhavingthepractitionershandsbecleanthroughproper handwashingaremostimportant. Therearenostudieswhichcompareskinpreparationpriortoacupunctureneedleinsertion withnoskinpreparation.Theclosestinformationavailablepertainstoskinpreparationpriorto injections,(40),suchasinsulininjectionsfordiabeticsandvaccinations.Researchconductedas 173 earlyasthe1960sbyDann(41)andKoivisto&Felig(42)withdiabeticpatientsindicatedthat althoughskinpreparationwithalcoholpriortoinjectionmarkedlyreducedskinbacterial counts,suchtreatmentisnotnecessarytopreventatinjectionsites.(43)In1999some standardsforimmunizationsandothersubcutaneousinjectionswerere-writtensuchthatskin preparationwasnotabsolutelynecessary.(44) Healthcareresearchhasreinforcedtheimportanceofensuringthattheskinofthepatientis physicallycleanandthathealthcareprovidersmaintainhighstandardsofhandhygienepriorto institutinganyprocedurethatincludesabreakintheskin.(45) TheWorldHealthOrganizationnolongerrecommendsswabbingcleanskinwithanantiseptic solutionbeforegivingintradermalorsubcutaneousneedleinjections,althoughintramuscular injectionsdorequireskinpreparationwith60-70%alcohol.(46)TheCDCstatesthatalcohol, soapandwaterorchemicalagentsarenotneededforpreparationoftheskinpriorto vaccination,unlesstheskinisgrosslycontaminatedordirty.(47)Inordertobeconsistentwith WHOandCDCguidelines,skincleansingshouldbecarriedoutwheneverthepractitioner expectstoneedlebelowthesubcutaneouslayer;inotherwordsintothemusclelayeror below. Otherresearchershaverecommendedthecleaningoftheinjectionsiteinordertominimize theriskofinfection.(48-50)Manypractitionersbelieveitfollowsbestpracticeguidelinesto cleantheskinpriortoinjectiontoreducetheriskofcontaminationfromthepatient’stransient skinflora. Thereisonecasereportofapatientwhoreportedlyhadsepticemiaafteracupunctureduring whichtheskinwasnotswabbed.ThecasewasreportedfromScotlandinwhicha69-year-old mandiedfromaninfectionafteracupuncturetreatmentatthethigh.Thepatientwaslater foundtohaveapreexistingpancytopenia(i.e.,lowtotalbloodcellcount,includingleukocytes), resultinginanincreasedsusceptibilitytoinfection.Thecasereportauthor,whoisalsothe practitioner,admittedthatthepatient’sskinattheacupuncturepointwasnotcleanedbefore theneedleinsertionandlaterfoundlocalmuscleinfectionwhichledtosepticemia.(51) Themostcommonandconvenientprocedureforcleaningapatient’sskinistheuseofan alcoholswab.Analcoholpumpdispenserandcottonballsmayalsobeusedinatreatment settingaslongasthecottonballsarediscardedwhendryorcontaminatedandthepump dispenseriscleanedwithanapproveddisinfectantonadailybasis(aswithanyothersurfacein thetreatmentroom). SincemanypatientscometotheAOMtreatmentlocationfromwork,attheendoftheday, afterexercising,andingenerallessfrequentlyimmediatelyaftershowering,itislikelythatthe acupuncturepointlocationsarenotcompletelyclean.Hands,feet,andthefacearecommonly 174 usedareasforacupunctureandareregularlyexposedtotransientorganismsduringthecourse ofregularhomeandworkactivities. AccordingtoaJuly2013letterfromtheCDC,(52)“TheproceduresoutlinedintheCNTManual arereasonable”regardingskinpreparation. Doesthismeanthatskinmustbecleanedwithalcoholswabspriortoneedleinsertion?Whatis clearisthattheskinmustbeclean,andthattheskintobetreatedshouldbefreefromovert infectionsorlesions.Howindividualpractitionerschoosetomakesuretheskiniscleanandfree oflesionsisaclinicaldecisioneachpractitionermustmake,basedontheprinciplesandsafety manualsinuseintheclinicalsettinginwhichtheypractice. Somestatesmandatetheuseofanantisepticswabbeforeinsertionofanacupunctureneedle intheirpracticeactsand/orrules.Thismanualshouldnotbeinterpretedasadvisingagainsta practiceoutlinedinstatelaw.Practitionershaveadutytoinvestigateandcomplywithstate regulation. Alcohol Swab Method Whendesired,preparedalcoholswabsareusedtocleanallsitesexpectedtobeneedledafter settingupthecleanfieldandbeforeneedling.Allowthesitetodry.Alternatively,applya60– 70%alcohol-basedsolution(isopropylalcoholorethanol)onasingle-useswaborcotton-wool ball.Donotusemethanolormethyl-alcoholasthesearenotsafeforhumanuse.(46) Swabbingtheacupunctureinsertionsitewithasaturated60-70%alcoholswabandallowing theskintodryisagoodpracticetoreducebothdirtandthenumberofpathogensatan acupuncturesite.Allowingthesitetodrypreventsstingingwhichmayoccurifalcoholistaken intothetissuesuponneedleentry.(50) Options for Skin Preparation Optionsforcleaningtheskinbeforeacupuncturebesides70%alcoholincluderequiringpatients towashallskinsurfacestobetreatedwithsoapandwater;orapplyingadisinfectingsolution containingchlorhexidinegluconate.(53)(Note:Fortopicalapplicationasaskindisinfecting solution,chlorhexidineismarketedundermanybrandnames,includingSpectrum-4,Hibistat, CalgonVesta,Betasept,Dyna-Hex,andHibiclens.) Useofpovidoneiodineantisepticointmentorbacitracin/gramicidin/polymyxinBointmentis notrecommendedasiodinemaybeabsorbedandmaycreatechangesinthyroidfunction,(54) andoveruseofbacitracinandotherantibioticointmentsmayleadtobacterialresistanceto theseproducts. 175 NoAOMprocedureshouldbeconductedwherethereareactivelesionsontheskin.All locationsshouldbecleansedbeforeproceedingwithacupunctureorotherprocedures.Useof 70%alcoholswabsorcottonsoakedin70%alcoholisaconvenientandcost-effectivemethod toimproveskincleanliness.Skincanbecleanedwithsoapandwaterorothermethodsthat ensurecleanliness. Ifalcoholisbeingused,swabthepointsandallowthealcoholontheskintodry.Thesame swabmaybeusedforseveralpointsaslongastheswabitselfisnotdryandhasonlytouched intactskin.Anewswabshouldbeusediftheswabbeginstochangecolor,becomesvisibly dirty,becomesdry,orhascomeintocontactwithanyskinbreak,lesion,inflammationor infection.Thealcoholshouldbeallowedtodrytoreducethepotentialfordiscomfortduring needling.Aseparateswabshouldbeusedforareasofhighbacterialfloraload,suchasthe axillaorgroin. Recommendations • • • • • • • • Critical:Avoidacupunctureinareasofactiveskinlesions. Critical:PerformAOMproceduresonlyinareasofcleanskin. Critical:Ensurethepatient’sskiniscleanbeforeinsertingneedlesorlancets. Critical:Whenusingalcoholswabs,useanewalcoholswabforeachpatientandanew swabiftheswabbeginstochangecolor,becomesvisiblydirty,becomesdry,orhas comeintocontactwithanyskinbreak,lesion,inflammationorinfection. StronglyRecommended:Swabeverypointwith70%alcoholorothercleansingagent priorto“wet”cupping,useoflancetsor7-starhammers. StronglyRecommended:Useaseparateswabforareasofhighbacterialfloraload,such asaxillaorgroin. Recommended:Havepatientscleanhandsandfacewithsoapandwaterpriorto acupunctureintheseareas. Recommended:Investigateandfollowlocalandstateregulationconcerningskin preparation. 3. Recommendations for Practitioner Health and Hygiene Review:Handwashingiscritical.Themostcommonmodeofhealthcare-associatedinfection transmissionisviathehands!Intheacupuncturist’spracticelocationsourcesofhand contaminationincludebodyfluidssuchasbloodandsaliva,andfluidsfromopenlesions.Body fluidsmaycontainbacteriasuchasStaphylococcusspecies,andvirusesassociatedwith hepatitisandHIV/AIDS.Itisabsolutelyimperativethatpotentiallyinfectiousfluidsnotbe transferredfromonepersontoanotherthroughtheacupunctureprovider’shands,orfromthe patienttothepractitionerand/orothermembersoftheclinicstaff.Thisismosteffectively donebycarefullywashinghandswheneverneeded.Handwashingshouldalsotakeplacebefore 176 andafteransweringthephone,afterusingacomputer,wheneverthepractitionertoucheshis orherfaceorhair,eats,orengagesinanyothernon-clinicalactivity. Yearly Physical Itisrecommendedthathealthcareprofessionals,includingacupuncturists,haveayearly physicalthatincludestestingfortuberculosis.NotethatTSTandPPDtestingaresimilar.The term“tuberculinskintests”(TSTs)isusedinsteadofpurifiedproteinderivative(PPD)inmost up-to-dateCDCinformation.(55) Clothing Itisrecommendedthatacupuncturistswearclean,washable,ordisposableprotectiveclothing whileperformingtreatments.Thefabricshouldbechosentoavoidtrappingandshedding contaminatingparticlesorinfectiousagentsinthecleanfield.Looseorlargejewelry,clothing, andhairstylesthattouchthepatientorbreakthecleanfieldshouldbeavoided.Open-toed shoesshouldnotbeworn,astheyposeariskofneedlestickintheeventthataneedleis dropped.Clothingshouldcoverthepractitioner’slegsandfeettopreventtheriskofa needlestickaccidentintheeventthataneedleisdropped. Hand Care Acupuncturistsmusttakegreatcaretomaintainthecleanlinessoftheirhands,keepingthe nailsshort.HandcleanlinessisapartofCleanNeedleTechnique.Itisstronglyrecommended thatallcutsandwoundsonthepractitioner’shandsbewashedanddressedimmediatelyfor theprotectionofbothpatientandpractitioner.Allcuts,wounds,abrasions,chappedhands, hangnails,torncuticles,etc.mustbecoveredbywearingafinger-cotornon-sterilenon-latex gloves. Personal Health Anacupuncturistwhoissufferingfromaninfectiousdiseasecantransmitthediseasetohisor herpatientinvariousways.Appropriatemedicalattentionshouldbesoughtforinfectious diseases.Generallyspeaking,patientcarepersonnelhavingovertclinicalinfection,suchas streptococcalpharyngitis(strepthroat),activeinfluenza,orastaphylococcalfuruncle(boil), shouldrestrictthemselvesfrompatientcontact.Personnelwithminorinfectionsoftheskinand minorviralinfectionsoftheupperrespiratorytractmayworksolongastheyarescrupulousin theirpracticeofpersonalhygieneandStandardPrecautionsarefollowed.(56)TheCDC recommendsthatHCWsbe“excludedfromworkuntilatleast24hoursaftertheynolonger haveafever(withouttheuseoffever-reducingmedicinessuchasacetaminophen).Thosewith ongoingrespiratorysymptomsshouldbeconsideredforevaluationbyoccupationalhealthto determineappropriatenessofcontactwithpatients.”(57) 177 • • StronglyRecommended:Thatacupuncturistsrefrainfromtreatingpatientswhenthey areactivelyill. Recommended:Thatacupuncturistscancelpatientcareuntilatleast24hoursafterthey nolongerhaveafeverforanyacuteinfection. Testing for TB, HBV, HCV and HIV TB testing Inadditiontoayearlyphysical,theCDCsuggeststhatpractitionerswhoworkinhighTB incidenceinnercityclinics,orthosewhoworkwithAIDSpatientsordrugaddicts,obtaina baselineTBtest,either2-stepTSTorachestradiographonhire.Educationregardingthe symptomsofTBshouldbeprovidedbyappropriatelytrainedpersonnel,andhealthcare workersshouldbescreenedforsymptomsannually.Settingswherethereisahighriskof infectionshouldbeevaluatedforenvironmentalinfectioncontrol,suchasairhandling.The transmissionofTBisarecognizedriskinsomehealthcaresettings.IntheCDC's2005 Recommendations for Preventing TB Transmission in Healthcare Settings,adetailedrisk stratificationisgivenforlowrisksettings,mediumrisksettings,andpotentialongoing transmissionsettings.Thislastclassificationshouldalwaysbetemporary,correctivesteps taken,andthereturntomediumriskmadewithinoneyear. EffectiveTBinfectioncontrolprogramsshouldbeimplementedinhealthcarefacilitiesand otherinstitutionalsettings(e.g.,sheltersforhomelesspersonsandcorrectionalfacilities).(55) ItisrecommendedthathealthcareprovidershaveannualTBskintestsorQuantiFERON© testing.IntheeventthatthepractitionerisfromapartoftheworldwhereTBisendemic,or hasbeenvaccinatedwithBacillusCalmette-Guerin(BCG),heorsheshouldhaveabaseline chestx-rayandanannualphysicalfromaqualifiedprovider. AlongwiththeirTBstatus,healthcareworkerswhoperformexposure-proneproceduresshould knowtheirHBVorHIVantibodystatus. HBV testing VarioustestsforHBVcandetecteitherthepresenceofthevirusitselforantibodiestothevirus. TestingforevidenceofhepatitisBinfectionshouldberoutineforhealthcareproviders, especiallythosewithoccupationalexposurepotential.Hospitalsandbloodbanksarerequired totestforHBVwithaverysensitivetestthatidentifiesHBVantigenmarkers. HCV testing Generally,theinitiallaboratorytestthatisdoneforHCVistodetermineifthepersonhas antibodiestothevirus.Ifthetestispositive,itmeansthatthepersonhasbeenexposedtothe 178 virusandmayormaynothaveactivehepatitisC.Additionaltestingwillneedtobedoneto determineifthepersonisacarrier,haschronichepatitis,orisimmune. HIV testing Generally,theinitiallaboratorytestthatisdoneforHIVistodetermineifthepersonhas antibodiestothevirus.Thistestcanhelpdetermineifthepersonhasbeeninfectedwiththe virusbutcannotdeterminethestageofdisease.TherearerapidHIVteststhatcanprovide resultswithin20minutesoftesting.Apositivetestshouldbeconfirmedwithawesternblotor IFA(immunoflourescentassay)test.(58) HealthcareworkerswhoareinfectedwithHIVorHBVshouldnotperformexposure-prone proceduresunlesstheyhavereceivedcounselingfromanexpertreviewpanelregardingthe circumstancesunderwhichtheymaycontinuetoperformtheseprocedures.Thereviewpanel shouldincludeexpertswhorepresentabalancedperspectiveandmayincludeallofthe following: 1. Thehealthcareworker’spersonalphysician. 2. AninfectiousdiseasespecialistwithexpertiseintheepidemiologyofHIVandHBV transmission. 3. Ahealthprofessionalwithexpertiseintheproceduresperformedbythehealthcare worker. 4. Stateorlocalpublichealthofficials. Ifthehealthcareworkerisinstitution-based,thepanelcouldincludethehospital epidemiologistorotherinfectioncontrolstaff.Healthcareworkersbasedoutsidethe hospital/institutionalsettingshouldseekadvicefromappropriatestateandlocalpublichealth officialsregardingthereviewprocess.(59) Itgoeswithoutsayingthatsuchpanelswouldberequiredtoobservetheconfidentialityand privacyrightsofinfectedhealthcareworkers.Infectedhealthcareworkersshouldnotify prospectivepatientsoftheirseropositivestatusbeforeundertakingexposure-proneinvasive procedures.Acupunctureisnotconsideredanexposure-proneinvasiveprocedure.Mandatory testingofhealthcareworkersforHIVantibodies,HBsAg,orHBeAgisnotrecommended.The riskisnotsufficienttojustifythecostssuchmandatorytestingprogramswouldincur. Education,training,andappropriateconfidentialitysafeguardsarethebestmeanstoinsure healthcareworkercompliancebyhealthcareworkerswithrecommendedprevention procedures. 4. Personal Protective Equipment (PPE) Seealso:http://www.cdc.gov/HAI/prevent/ppe.html 179 StandardPrecautionsisanoutgrowthofUniversalPrecautions.UniversalPrecautionswerefirst recommendedbytheCDCin1987topreventthetransmissionofbloodbornepathogensto healthcarepersonnel.In1996,theapplicationoftheconceptwasexpandedandrenamed StandardPrecautions.StandardPrecautionsareintendedtopreventthetransmissionof commoninfectiousagentstohealthcarepersonnel,patientsandvisitorsinanyhealthcare setting.Duringcareforanypatient,oneshouldassumethataninfectiousagentcouldbe presentinthepatient’sbloodorbodyfluids,includingallsecretionsandexcretionsexcepttears andsweat.Thereforeappropriateprecautions,includinguseofPPE,mustbetaken.Whether PPEisneeded,andifso,whichtype,isdeterminedbythetypeofclinicalinteractionwiththe patientandthedegreeofbloodandbodyfluidcontactthatcanbereasonablyanticipatedand bywhetherthepatienthasbeenplacedonisolationprecautionssuchasContactorDroplet PrecautionsorAirborneInfectionIsolation.(60) Personalprotectiveequipment,orPPE,asdefinedbytheOccupationalSafetyandHealth Administration,orOSHA,is“specializedclothingorequipment,wornbyanemployeefor protectionagainstinfectiousmaterials.”(61) OSHAissuesregulationsforworkplacehealthandsafety.TheseregulationsrequireuseofPPE inhealthcaresettingstoprotecthealthcarepersonnelfromexposuretobloodbornepathogens andMycobacteriumtuberculosis.However,underOSHA’sGeneralDutyClausePPEisrequired foranypotentialinfectiousdiseaseexposure.Employersmustprovidetheiremployeeswith appropriatePPEandensurethatPPEisdisposedor,ifreusable,thatitisproperlycleanedor laundered,repairedandstoredafteruse.Theemployermustcoverthepurchaseandcleaning costsforthePPEforallpersonnel. TheCentersforDiseaseControlandPrevention(CDC)issuesrecommendationsforwhenand whatPPEshouldbeusedtopreventexposuretoinfectiousdiseases. OSHAissuesworkplacehealthandsafetyregulations.RegardingPPE,employersmust: • • ProvideappropriatePPEforemployeesatnocosttotheemployees. EnsurethatPPEisdisposedofproperly;or,ifreusable,theemployerensuresthatthe PPEiscleaned,laundered,repaired,andstoredafteruse. OSHAalsospecifiescircumstancesforwhichPPEisindicated.TheCDCrecommendswhen, what,andhowtousePPEforHCWs. TypesofPPEUsedinHealthCareSettings:(62) § § Gloves–protecthands Gowns/aprons/labcoats–protectskinand/orclothing 180 § § § Masksandrespirators–protectmouth/nosefrominfectioussubstances Goggles–protecteyes Faceshields–protectface,mouth,nose,andeyes GlovesarethemostcommontypeofPPEusedinhealthcaresettings.Mostpatientcare activitiesthatinvolvemucusmembranes,blood,orOPIMrequiretheuseofasinglepairof nonsterileglovesmadeofeithernitrileorvinyl.Avoidtheuseoflatexglovesduetopatientand HCWallergies.Glovesshouldfittheuser’shandscomfortably–theyshouldnotbetoolooseor tootight.Theyalsoshouldnottearordamageeasily.GlovesprotecttheHCWagainstcontact withinfectiousmaterials.However,oncecontaminated,glovescanbecomeameansfor spreadinginfectiousmaterialstoyou,otherpatientsorenvironmentalsurfaces.Glovesdonot preventneedlestickinjuries. UnderStandardPrecautions,glovesshouldbeusedwhentouchingblood,bodyfluids, secretions,excretions,orcontaminateditemsandfortouchingmucousmembranesandnonintactskin.(62) Are gloves needed for acupuncture needle insertion? Glovesgenerallydonotneedtobeusedtoinsertanacupunctureneedle.Glovesneedtobe used,however,whenbloodorOPIMisexpectedtobepresentduringahealthcareprocedure andwhenperformingproceduresonareasofmucusmembranes.(63,64)OccupationalSafety andHealthAdministration(OSHA)regulationsdonotrequireglovestobewornwhen administeringvaccinesunlessthepersonadministeringthevaccineislikelytocomeinto contactwithpotentiallyinfectiousbodyfluidsorhasopenlesionsonthehands.(65)According totheWorldHealthOrganization(WHO),routineintradermal,subcutaneous,and intramuscularinjectionadministrationdoesnotrequiretheuseofglovesifthehealthworker’s skinisintact.(42)Acupunctureneedleinsertionissimilartoasubcutaneousorintramuscular needleinsertion.Sincebleedingoccursonlyextremelyrarelyduringneedleinsertion,glovesare notneededforacupunctureneedleinsertion. ThisinterpretationwasechoedinaletterfromOSHAtoaninquiryofMay11,2005,fromthe DirectoroftheDepartmentofVeteransAffairsregardingtheuseofglovesforacupuncture: AccordingtotheWHO,theneedlepenetrationusedforacupunctureisdescribedtobe similartoasubcutaneousorintramuscularinjection.Ingeneral,OSHAdoesnotconsider itnecessarytousegloveswhengivingsubcutaneousorintramuscularinjectionsaslong asbleedingthatcouldresultinhandcontactwithbloodorOPIMisnotanticipated.The samewouldbetruewithacupunctureproceduresaslongascontactwithbloodisnot anticipated.(66) 181 Averyfewpointlocationsdorequiregloveuseduringneedlingduetotheirlocationonornear mucousmembranes.TheseincludeRen1(Huiyin),Du1(Changqian),Du27(Duiduan),Du28 (Yinjiao),JinjinandYuye(M-HN-20). Are gloves needed for acupuncture needle removal? Ingeneral,thereisnoneedtousegloveswhenremovinganacupunctureneedle.Theriskof bleedingduringmostacupunctureneedleremovalislessthan4%.(67)Thereisgenerallyno needforglovesduringneedleremoval.However,sometypesofneedlingofthescalporears mayincreasetheriskforbleeding.Further,OSHAstatesthat“Ifanemployeeisrequiredto cleananddresstheacupuncturesitesfollowingtheextractionoftheneedlesandanybleeding isanticipated,thenglovesmustbewornwhendoingso.”(66) Pleasenotethatlikeneedleinsertion,removingneedlesfrompointslocatedinornearmucous membranesdoesrequiretheuseofgloves. UnderOSHABBPstandard29CFR1910.1030,acupuncturistsmustfollowemployerpoliciesand proceduresaboutwhenglovesneedtobeused.AccordingtoOSHA,“anemployermust establishpoliciestoimplementthisprovision(29CFR1910.1030(c)).Theindividualemployee performingacupuncturedoesnotmakethedeterminationwhetherglovesaretobeworn.” (68)Ifanacupuncturistisself-employed,heorsheshouldhaveasetofguidelinestofollow regardingtheuseofglovesforallprocedures. AdditionalCDCguidelinesforwearinggloves(60)include: • • • • • Weargloveswithfitanddurabilityappropriatetothetask. Weardisposablemedicalexaminationglovesfordirectpatientcare. Removeglovesaftercontactwiththepatientand/ormedicalequipmentorthe environment(roomsurfaces). Donotwearthesameglovesforthecareofmorethanonepatient. Removeglovesusingpropertechniquetopreventhandcontamination. Notethathandwashingisrequiredafterremovalofgloves.Itiscriticalthatproperhand hygieneispracticedalongwithgloveusetobestprotecthealthcarepersonnel.(61) Goggles: Gogglesprovidebarrierprotectionfortheeyes;personalprescriptionlensesdonotprovide optimaleyeprotectionandinmostcircumstancesshouldnotbeusedasasubstitutefor goggles.Gogglesshouldfitsnuglyoverandaroundtheeyes.Gogglespreventthesplashingof bloodorOPIMintotheeyes.Theyalsokeephandsthatmaybecontaminatedfromhealthcare practicesfromtouchingtheeyes. 182 Gogglesorafaceshieldshouldbeusedduringpatientcareactivitiesthatarelikelytogenerate splashesandspraysofblood,bodyfluids,secretions,orexcretions.ExamplesinAOMinclude bleedingtechniques,includingwetcupping. LabCoats: Labcoatsarepersonalprotectiveequipmentandshouldbeworninthelabwhenworkingwith chemicalsandbiologicalstoprotecttheskinandclothingfromsplatterandspills.Appropriate labcoatsshouldbefullybuttonedwithsleevesrolleddown.Inordertopreventthespreadof contaminantsdonotwearlabcoatsinpublicplaces,suchasoffices,lunchrooms,loungeareas, orelsewhereastheycantransferhazardousmaterialsandcontaminatetheseareas.Donot bringlabcoatshomebecauseyoumaycontaminateothersinthehousehold.Donotlaunder labcoatsathomeorwithotherclothing.LabcoatsusedforPPEshouldbelaunderedbya medicalorlaboratorylaundryservice.(61) InadditiontowearingPPE,youshouldalsousesafeworkpractices.Avoidcontaminating yourselfbykeepingyourhandsawayfromyourfaceandnottouchingoradjustingPPE.Also, removeyourglovesiftheybecometornandperformhandhygiene(washhands)before puttingonanewpairofgloves.Youshouldalsoavoidspreadingcontaminationbylimiting surfacesanditemstouchedwithcontaminatedgloves. 5. Needlestick Information (http://www.cdc.gov/niosh/docs/2000-108/)(68) IfyouexperienceaneedlestickorsharpsinjuryorareexposedtothebloodorOPIMofa patient,followthesesteps: • Washneedlesticklocationsandcutswithsoapandwater. • Flushsplashestothenose,mouth,orskinwithwater. • Irrigateeyeswithcleanwater,saline,orsterileirrigants. • Seekmedicaladvicefromalicensedphysicianassoonaspossible. References 1.WorldHealthOrganization.WHOGuidelinesonHandHygieneinHealthCare. http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf.2009.Accessed December2012 2.CentersforDiseaseControlandPrevention.HandHygieneinHealthcareSettings–Core. CentersforDiseaseControl. http://www.cdc.gov/handhygiene/download/hand_hygiene_core.pdf.2002.Accessed December2012. 3.CentersforDiseaseControlandPrevention.DivisionofMediaRelations.Whyishandwashing important?DivisionofMediaRelations. 183 http://www.cdc.gov/media/pressrel/r2k0306c.htm.March2000.AccessedDecember 2012. 4.SteereAC.Handwashingpracticesforpreventionofnosocomialinfections.AnnInternMed 1975;83:683-90. 5.DomowitzLG.Handwashingtechniquesinpaediatricintensivecareunit.AmJDisChild 1987;141:633-85. 6.ThompsonBL,DwyerDM,UsseryXT,DenmanS.Handwashingandgloveuseinlong-term carefacility.InfectContHospEpidemol1997;18:97-103. 7.OjajärviJ,MäkeläP,RantasaloI.Failureofhanddisinfectionwithfrequenthandwashing:a needforprolongedfieldstudies.JHyg(Lond)1977;79:107–19. 8.LarsonEL,EkePI,WilderMP,LaughonBE.Quantityofsoapasavariableinhandwashing. InfectControl1987;8:371–5. 9.LarsonE,LeydenJJ,McGinleyKJ,GroveGL,TalbotGH.Physiologicandmicrobiologicchanges inskinrelatedtofrequentskinrelatedtofrequenthandwashing.InfectControl.1986 Feb;7(2):59-63. 10.LarsonEL,EkePI,LaughonBE.Efficacyofalcohol-basedhandrinsesunderfrequent-use conditions.AntimicrobAgentsChemother1986;30:542–4. 11.LarsonEL,LaughonBE.Comparisonoffourantisepticproductscontainingchlorhexidine gluconate.AntimicrobAgentsChemother1987;31:1572–4. 12.BoyceJM,PittetD.GuidelineforHandHygieneinHealth-CareSettings;Recommendations oftheHealthcareInfectionControlPracticesAdvisoryCommitteeandthe HICPAC/SHEA/APIC/IDSAHandHygieneTaskForce.MMWRRecommendationsand Reports,October25,2002/51(RR16);1-44. 13.RotterM.Handwashingandhanddisinfection[Chapter87].In:MayhallCG,ed.Hospital epidemiologyandinfectioncontrol.2nded.Philadelphia,PA:LippincottWilliams& Wilkins,1999. 14.PittetDetal.InfectioncontrolasamajorWorldHealthOrganizationpriorityfordeveloping countries.JHospInfect.2008Apr;68(4):285-92.doi:10.1016/j.jhin.2007.12.013.Epub 2008Mar10. 15.Izquierdo-CubasFetal.Nationalprevalenceofnosocomialinfections,Cuba2004.Journalof HospitalInfection,2008,68:234–240. 16.CoelloRetal.Prospectivestudyofinfection,colonizationandcarriageofmethicillinresistantStaphylococcusaureusinanoutbreakaffecting990patients.EuropeanJournal ofClinicalMicrobiology,1994,13:74–81. 17.MermelLA,JosephsonSL,DempseyJ,ParenteauS,PerryC,MagillN.OutbreakofShigella sonneiinaclinicalmicrobiologylaboratory.JClinMicrobiol1997;35:3163–5. 18.ShlenschlaegerJ,FribergJ,RamsingD,AgnerT.Temperaturedependencyofskin susceptibilitytowateranddetergents.ActaDermVenereol1996;76:274–6. 184 19.EmilsonA,LindbergM,ForslindB.Thetemperatureeffectofinvitropenetrationofsodium laurylsulfateandnickelchloridethroughhumanskin.ActaDermVenereol 1993;73:203–7. 20.AnsariSA,SpringthorpeVS,SattarSA,TostowarykW,WellsGA.Comparisonofcloth,paper, andwarmairdryingineliminatingvirusesandbacteriafromwashedhands.AmJInfect Control1991;19:243–9. 21.LarsonEL,McGinleyKJ,FogliaA,LeydenJJ,BolandN,LarsonJ,AltobelliLC,Salazar-LindoE. Handwashingpracticesandresistanceanddensityofbacterialhandfloraontwo pediatricunitsinLima,Peru.AmJInfectControl1992;20:65–72. 22.PittetDetal.InfectioncontrolasamajorWorldHealthOrganizationpriorityfordeveloping countries.JournalofHospitalInfection,2008,68:285–292. 23.LarsonELetal.Changesinbacterialfloraassociatedwithskindamageonhandsofhealth carepersonnel.AmericanJournalofInfectionControl,1998,26:513–521. 24.TaylorLJ.Anevaluationofhandwashingtechniques.NursingTimes1978:54–5. 25.OjajärviJ.Anevaluationofantisepticsusedforhanddisinfectioninwards.JHyg(Lond) 1976;76:75–82. 26.PricePB.Thebacteriologyofnormalskin:anewquantitativetestappliedtoastudyofthe bacterialfloraandthedisinfectantactionofmechanicalcleansing.JournalofInfectious Diseases,1938,63:301–318. 27.MontesLF,WilbornWH.Locationofbacterialskinflora.BritishJournalofDermatology. 1969,81(Suppl.1):23–26. 28.WilsonM.Microbialinhabitantsofhumans:theirecologyandroleinhealthanddisease. NewYork,NY,CambridgeUniversityPress,2005. 29.RayanGM,FlournoyDJ.Microbiologicfloraofhumanfingernails.JournalofHandSurgery (America).1987,12:605–607. 30.EvansCAetal.Bacterialfloraofthenormalhumanskin.JournalofInvestigative Dermatology.1950,15:305–324. 31.KampfG,KramerA.Epidemiologicbackgroundofhandhygieneandevaluationofthemost importantagentsforscrubsandrubs.ClinicalMicrobiologyReview,2004,17:863–893. 32.LarkRLVanderHydeK,DeebGM,DietrichS,MasseyJP,ChenowethC.Anoutbreakof coagulase-negativestaphylococcalsurgical-siteinfectionsfollowingaorticvalve replacement.InfectControlHospEpidemiol.2001Oct;22(10):618-23. 33.BodeScienceCenter.Transientskinflora.http://www.bode-sciencecenter.com/center/glossary/transient-skin-flora.html.AccessedDecember2012 34.HoffmanPN,CookeEM,McCarvilleMR,EmmersonAM.Microorganismsisolatedfromskin underweddingringswornbyhospitalstaff.BrMedJ1985;290:206–7. 35.JacobsonG,ThieleJE,McCuneJH,FarrellLD.Handwashing:ringwearingandnumberof microorganisms.NursRes1985;34:186–8. 185 36.HayesRA,TrickWE,VernonMO,etal.Ringuseasariskfactor(RF)forhandcolonizationin asurgicalintensivecareunit(SICU)[AbstractK-1333].In:Programandabstractsofthe 41stInterscienceConferenceonAntimicrobialAgentsandChemotherapy.Washington, DC:AmericanSocietyforMicrobiology,2001. 37.HarrisAD,SamoreMH,NafzigerR,DiRosarioK,RoghmannMC,CarmeliY.Asurveyon handwashingpracticesandopinionsofhealthcareworkers.JHospInfect.2000 Aug;45(4):318-21. 38.Boyce,J.M.,etal.,Proceedingsofthe9thAnnualSocietyforHealthCareEpidemiologyof AmericaMeeting,April18-20,1999,SanFrancisco,CA 39.29CFR1910.1030(d)(2)(iv),whichspecifiesthat“whenprovisionofhandwashingfacilities isnotfeasible,theemployershallprovideeitheranappropriateantiseptichandcleanser inconjunctionwithcleancloth/papertowelsorantiseptictowelettes.Whenantiseptic handcleansersortowelettesareused,handsshallbewashedwithsoapandrunning waterassoonasfeasible.” 40.KhawajaR,SikandarR,QureshiR,JarenoR.RoutineSkinPreparationwith70%Isopropyl AlcoholSwab:IsitNecessarybeforeanInjection?QuasiStudy.JLiaquatUMedHealth Sciences(JLUMHS).2013;12(2)(May-Aug):109-14. 41.DannTC.Routineskinpreparationbeforeinjection:anunnecessaryprocedure.Lancet 1969;2:96-7. 42.KoivistoJA,FeligP.Isskinpreparationnecessarybeforeinsulininjection?Lancet1978;1: 1072-1073. 43.McCarthyJA,CovarrubisB,SinkP.Isthetraditionalalcoholwipenecessarybeforeaninsulin injection?DiabetesCare1993;16(1);402. 44.WorkmanB.Safeinjectiontechniques.NursingStandard1999;13(39):47-53. 45.RotterM.Handwashingandhanddisinfection.MayhallCG.EdHospitalepidemiologyand infectioncontrol,2ndEdition.Philadelphia.Lippincott,1999. 46.WorldHealthOrganization.WHObestpracticesforinjectionsandrelatedprocedures toolkit.http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf.WHO LibraryCataloguing-in-PublicationData.2010.AccessedDecember2012. 47.Modlin,JohnF.,etal.Vaccinia(Smallpox)VaccineRecommendationsoftheAdvisory CommitteeonImmunizationPractices(ACIP),2001.MMWRJune200150(RR10):1-25. 48.MallettJ,BaileyC.TheRoyalMarsdenNHSTrustManualofClinicalProcedures(5thed.) BlackwellScience:London1996. 49.LawrenceJC.Theuseofalcoholicwipesfordisinfectionofinjectionsites.JournalofWound Care1994;3(1):1-14. 50.DedgeonJA.Immunisation:PrinciplesandPractice.London.Chapman&Hall,1991. 51.Simmons,R..Acupuncturewithsignificantinfection,ina‘well’patient.Acupuncturein Medicine2006;24(1):37. 186 52.Hageman,JeffreyMHS,DeputyChief,DivisionofHealthcareQuality,CDCAltantaGAto DavidSale,ExecutiveDirectorCCAOM(copyonfileatCCAOMNationalOffice).2013. Letter. 53.CentersforDiseaseControlandPrevention.GuidelinesforthePreventionofIntravascular Catheter-RelatedInfections.http://www.cdc.gov/hicpac/BSI/05-bsi-background-info2011.html.ReviewedApril1,2011.AccessedDecember2012. 54.BroganTV,BrattonSL,LynnAM.Thyroidfunctionininfantsfollowingcardiacsurgery: comparativeeffectsofiodinatedandnoniodinatedtopicalantiseptics.CritCare Med.1997Sep;25(9):1583-7. 55.CentersforDiseaseControlandPrevention.GuidelinesforPreventingtheTransmissionof MycobacteriumtuberculosisinHealth-CareSettings,2005. http://www.cdc.gov/mmwr/PDF/rr/rr5417.pdfMMWR2005;54(No.RR-17).Accessed April2013. 56.OSHA.1910.1030Bloodbornepathogens. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p _id=10051.AccessedDecember2012 57.CentersforDiseaseControlandPrevention.PreventionStrategiesforSeasonalInfluenzain HealthcareSettings.CentersforDiseaseControl. http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm. ReviewedJanuary9,2013.AccessedJanuary2013. 58.IppolitoG,PuroV,CarliG.TheRiskofOccupationalHumanImmunodeficiencyVirus InfectioninHealthCareWorkers:ItalianMulticenterStudy.ArchIntern Med.1993;153(12):1451-1458.doi:10.1001/archinte.1993.00410120035005. 59.HICPACImmunizationofHealth-Careworkers:RecommendationsoftheAdvisory CommitteeonImmunizationPractices(ACIP)andtheHospitalInfectionControl PracticesAdvisoryCommittee(HICPAC),MMR1997;46(No.RR18). 60.CentersforDiseaseControlandPrevention.GuidancefortheSelectionandUseofPersonal ProtectiveEquipment(PPE)inHealthcareSettings. http://www.cdc.gov/hai/pdfs/ppe/ppeslides6-29-04.pdf.AccessedDecember2012. 61.OSHAFactSheet:PersonalProtectiveEquipment(PPE)ReducesExposuretoBloodborne Pathogens.https://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact03.pdf.2011. AccessedDecember2012. 62.OSHAFactSheet:PersonalProtectiveEquipment.2003. http://www.osha.gov/Publications/osha3151.html.AccessedDecember2012. 63.CentersforDiseaseControlandPrevention.HealthcareInfectionControlPracticesAdvisory Committee(HICPAC).GuidelineforIsolationPrecautions:PrecautionstoPrevent TransmissionofInfectiousAgentsinGuidelineforIsolationPrecautions2007. 187 http://www.cdc.gov/hicpac/2007ip/2007ip_part3.html.ReviewedDecember29,2009. AccessedNovember2012. 64.CentersforDiseaseControlandPrevention.Guidelinesforenvironmentalinfectioncontrol inhealth-carefacilities:recommendationsofCDCandtheHealthcareInfectionControl PracticesAdvisoryCommittee(HICPAC). http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf.MMWR2003;52(No. RR-10):1–48.AccessedDecember2012. 65.CentersforDiseaseControlandPrevention.EpidemiologyandPreventionofVaccinePreventableDiseases.AtkinsonW,WolfeS,HamborskyJ,eds.12thed.,secondprinting. WashingtonDC:PublicHealthFoundation,2012.PageD-4. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/appdx-full-d.pdf. AccessedFebruary2015. 66.Fairfax,RichardE,Director,OSHADirectorateofEnforcementPrograms,toJohnA. Hancock,Director,DepartmentofVeteransAffairs(copyonfileatCCAOMNational Office).ThisletterwasOSHA’sinterpretationof29C.F.R.1910.1030(d)(3)(ix).2005. Letter. 68.Kalinowski,DouglasJ.,Director,OSHADirectorateofCooperativeandStatePrograms,to DavidM.Sale,ExecutiveDirector,CCAOM(copyonfileatCCAOMNationalOffice) March8,2013.Letter. 67.Park,Ji-EunLee,MyeongSoo;Choi,Jun-Yong;Kim,Bo-Young;Choi,Sun-Mi.Adverseevents associatedwithacupuncture:aprospectivestudy.JAlternComplementMed;Volume: 16,Issue:9,Date:2010Sep,Pages:959-63.2010. 68.CentersforDiseaseControlandPrevention.PreventingNeedlestickinjuriesinthe HealthcareSettings.http://www..gov/niosh/docs/2000-108/pdfs/2000-108.pdf.DHHS NationalInstituteforOccupationalSafetyandHealth.(NIOSH)PublicationNo.2000-108. November1999.AccessedNovember2012. 188 Part VI: Cleaning and Pathogen Reduction Techniques in Healthcare and AOM Practice Locations TheWHO,CDCandOHSAstandardsforcleaninganddisinfectionapplytoalltypesof healthcarepractices.Thesepracticesarenotspecifictoacupuncturepractices.Acupuncture schoolsandclinicsoffertraininginthepracticalapplicationsoftheseregulationsforthe acupuncturepractitioner. Anacupuncturist’streatmentlocationshouldbekeptcleanandsanitary.OSHArequiresthat theworkplacebemaintainedinacleanandsanitaryconditionandthatthereisanappropriate writtenscheduleforcleaninganddecontamination.Thecleanlinessofthegeneralenvironment alsohasadirectimpactonthepractitioner’sabilitytocreateacleanfield.Ifacustodial contractorisresponsibleforclinicmaintenance,thecontractormustbeinstructedregarding maintenanceandthepresenceofbiohazardousmaterials.Theclinicmanagermustprovide writtennotificationtocleaningcontractorsregardingthepresenceofcontaminatedsharpsand thepotentialforbloodbornecontamination.Asinkwithhotandcoldrunningwatermustbe locatedinornearthetreatmentrooms.Liquidhandsoapandpapertowelsmustbeavailableat handwashingstations.Alcohol-basedhandsanitizersmayalsobeavailable. Single-use,disposabletowelsshouldbeusedtodrythehands.Cleanpapertowelsare appropriate.Anypaperorotherdisposablematerialusedasacoveringonachair,seat,couch, ortreatmenttable,andanytowel,cloth,sheet,gown,orotherarticlethatcontactsthe patient’sskinshouldbeclean,andshouldnotpreviouslyhavebeenusedinconnectionwith anyotherpatientunlesslaunderedbeforereuse. Thetreatmentroomtabletops,shelvesandotherworkingsurfacesshouldhaveasmooth, impervioussurface,beingoodrepair,andbecleanedwithasuitabledisinfectantatleastonce adayandwhenevervisiblycontaminatedorwheneverapatientmayhavecontaminatedthe surfacebycomingincontactwiththesurfacedirectly.HepatitisBviruscansurviveonsurfaces foratleastoneweekatroomtemperature.(1)Treatmenttablesandchairsusedfortreatments needtobedisinfectedbetweeneachpatientvisit. 1. Disinfectants Disinfectantsarerecommendedforofficesurfacesandequipment.Disinfectantsdonotkillall germsorspores,buttheywillreducethedangerofinfection.EPA-registereddisinfectantsfor clinicalsettingsneutralizemostviruses,includinghepatitisB.Thesesolutionslosestrengthover timeandmustberemadeatspecifiedintervals,asperthemanufacturer’slabelinstructionsfor thetypesofsurfacesbeingdisinfected. 189 EPA-registereddisinfectantsforroomsurfacesandFDA-cleareddisinfectantsforreusable medicaldevicesneedtobemixedasperpackagedirectionsforclinicalpracticesettings.Check withthemanufacturerfordilutionprotocolsandexpirationtimesoncommercialdisinfectants. Themanufacturer’sdirectionsmustbestrictlyfollowed.Disinfectantsmustbelabeledifnotin theoriginalbottle.Thelabelshouldstatewhatthesolutionis,whenitwasmixed,andthe concentration.Useddisinfectantsmustbecarefullydiscardedaccordingtothemanufacturer’s instructions. Classifications of Disinfectants Chemicalgermicidesareclassifiedbyseveraldifferentsystems.TheEnvironmentalProtection Agency(EPA)classifiesthemaccordingtoclaimsbythemanufacturer,buttheEPAdoesnot performindependenttestsofefficacy.Itisimportant,therefore,tounderstandthe manufacturer’slabeltointerprettheusefulnessofaproductforitsstatedpurpose.Potential confusioninreadinglabelsisshowninthediscussionbelowcomparingCDCandEPA classifications. “Sterilant”isthetermusedtodescribeagermicidethatisusedinsuchawaythatitcan actuallysterilize.Thesamesubstance,calledasporicidebytheEPA,mightfunctionaseithera sterilantorahigh-leveldisinfectant,dependingonconcentration,contacttime,andthe temperatureatwhichitisused.Thesechemicalsarequitetoxicandarenotusedforoffice cleaning/disinfecting. TheCDCclassificationsystemestablishesthreecategoriesofitemsrequiringsterilizationand disinfection:critical,semi-critical,andnon-critical.Theclassificationsrelatetowhatpartofa patienttheitemswillcontact.Criticalobjectsenterthevascularsystemoranysterileinternal partofthebody.TheCDCclassifiesprocessesormethodstoachievetheselevelstobe sterilants.Semi-criticalitemstouchmucusmembranesandnon-intactskin,andnon-critical itemstouchintactskin. Disinfectantsmaybeclassifiedashigh-leveldisinfectants,intermediate-leveldisinfectants,and low-leveldisinfectants.“Sanitizers”(anEPAclassificationfrequentlyusedindiscussion) correspondtotheCDC’slow-leveldisinfectants.Productlabelsoftendescribethelevelof germicidalactionintermsoftheinfectiousagentstheychallenge. Types of Disinfectants Chlorine and Chlorine Compounds ThemostprevalentchlorineproductsintheUnitedStatesareaqueoussolutionsof5.25%– 6.15%sodiumhypochlorite.Theseproductshaveabroadspectrumofantimicrobialactivity,do notleavetoxicresidues,areunaffectedbywaterhardness,areinexpensiveandfastacting,and 190 havealowincidenceofserioustoxicity.(2)Sodiumhypochloriteattheconcentrationusedin householdbleach(5.25-6.15%)canproduceocularirritationororopharyngeal,esophageal,and gastricburns.(3)Otherdisadvantagesofhypochloritesincludecorrosivenesstometalsinhigh concentrations(>500ppm),inactivationbyorganicmatter,discoloringor"bleaching"offabrics, andreleaseoftoxicchlorinegaswhenmixedwithammoniaoracid(e.g.,householdcleaning agents).(4)Afterreviewingenvironmentalfateandecologicdata,EPAhasdeterminedthe currentlyregisteredusesofhypochloriteswillnotresultinunreasonableadverseeventstothe environment.(5)Commercial,EPA-approveddilutionsofsodiumhypochloriteshouldbe preparedaccordingtomanufacturerinstructionsbutmayneedtobeusedwithin24hoursof preparation.Followmanufacturerdirectionsforuseonbothsmooth,impervioussurfacesand poroussurfacesororganicmaterial.Practitionersneedtofollowlabeldirectionsforthe appropriateconcentrationsfornon-criticalandsemi-criticalreusabledevicesaswellasfor cleaningofcommonsurfaceswithhypochloritesolutions. TheCDCnolongeracceptshouseholdbleachasasuitableinstrumentdisinfectingsolutionin thehealthcaresetting. Microbiocidal Activity Hypochloriteconcentrationsapprovedforuseonnon-criticalitemsandcommonsurfaceshave abiocidaleffectonmycoplasmaandbacteriainseconds.(6)Higherconcentrationsarerequired tokillM.tuberculosis,Clostridiumdifficilespores,andotherHAI.(7)Onestudyreportedthat25 differentviruseswereinactivatedin10minuteswithhighconcentrationhypochlorite solution.(8)Severalstudieshavedemonstratedtheeffectivenessofdilutedsodium hypochloriteandotherdisinfectantstoinactivateHIV.(9) Glutaraldehyde Glutaraldehydeisasaturateddialdehydethathasgainedwideacceptanceasahigh-level disinfectantandchemical.(2)Aqueoussolutionsofglutaraldehydeareacidicandgenerallyin thisstatearenotsporicidal.Onlywhenthesolutionis"activated"(madealkaline)byuseof alkalinizingagentstopH7.5–8.5doesthesolutionbecomesporicidal.Onceactivated,these solutionshaveashelf-lifeofminimally14days.(2)Glutaraldehydegivesoffvaporsthatare respiratoryirritantsandcausecontactdermatitis.Ithaslimitationsinitsmycobacteriocidal activityandcoagulatesbloodandtissuetosurfaces.(10) Glutaraldehydeisusedmostcommonlyasahigh-leveldisinfectantformedicalequipmentsuch asendoscopes,dialyzers,transducers,anesthesiaandrespiratorytherapyequipment,and othermedicaldevicesthatenterthebody.Glutaraldehydeshouldnotbeusedforcleaning noncriticalsurfacesbecausetheyaretootoxicandexpensive. 191 Hydrogen peroxide Stabilizedhydrogenperoxidein6%to25%concentrationsisalsocapableofhigh-level disinfection.Thesubstanceisnottoxicanddoesnotneedhoodventilationforuse.The hydrogenperoxidesoldover-the-counterinpharmaciesis3%andisoftenold,resultinginless effectivenessthanthatprovidedbyafresh3%peroxidesolution.Over-the-counterhydrogen peroxidesolutionswillnotsterilizeeffectively.(2)FDA-clearedhydrogenperoxidesolutionsare availableundernumerousbrandnames,includingSporox. Iodophors Iodinesolutionsortinctureshavebeenusedbyhealthprofessionalsprimarilyasantisepticson skinortissue.Iodophors,ontheotherhand,havebeenusedbothasantisepticsand disinfectants.FDAhasnotclearedanyliquidchemicalhigh-leveldisinfectantswithiodophorsas themainactiveingredient.(2) Phenol Phenolhasoccupiedaprominentplaceinthefieldofhospitaldisinfectionsinceitsinitialuseas agermicidebyListerinhispioneeringworkonantisepticsurgery.Manyphenolicgermicides areEPA-registeredaslow-leveldisinfectantsforuseonenvironmentalsurfaces(e.g.,bedside tables,bedrails,andlaboratorysurfaces)andnoncriticalmedicaldevices.Phenolicsarenot FDA-clearedashigh-leveldisinfectantsforusewithsemicriticalitems.(2) EPA and FDA Approval of Disinfectants IntheUnitedStates,chemicalgermicidesformulatedassanitizers,disinfectants,orsterilants areregulatedininterstatecommercebytheAntimicrobialsDivision,OfficeofPesticides Program,EPA,undertheauthorityoftheFederalInsecticide,Fungicide,andRodenticideAct (FIFRA)of1947.(11)UnderFIFRA,anysubstanceormixtureofsubstancesintendedtoprevent, destroy,repel,ormitigateanypest(includingmicroorganismsbutexcludingthoseinoron livinghumansoranimals)mustberegisteredbeforesaleordistribution. AlistofproductsregisteredwithEPAandlabeledforuseassterilantsortuberculocidesor againstHIVand/orHBVisavailablethroughEPA'swebsiteat: http://www.epa.gov/oppad001/chemregindex.htm AlistofFDAapprovedhigh-leveldisinfectantscanbefoundhere: http://www.fda.gov/medicaldevices/deviceregulationandguidance/reprocessingofreusablemed icaldevices/ucm437347.htm Monitoring and Labeling of Disinfectants Alldisinfectantsshouldbehandledaccordingtothemanufacturer’sinstructions.Hypochlorite solutionsshouldbemadefreshdailyaccordingtotheuseforwhichthesolutionisintended. 192 OSHAregulationsrequirethatcontainersofdisinfectantmustbelabeledifnotintheiroriginal bottle.Thelabelmustincludewhatthesolutionis,whenitwasmixed,anditsconcentration. AnMSDS(ManufactureSafetyDataSheet)shouldalwaysbeavailableincaseofaccidents. 2. Indications for Sterilization, High-Level Disinfection, and LowLevel Disinfection AccordingtotheCDC:(2) • • • Sterilizationisrequiredforinstrumentsthatenternormallysteriletissueorthevascular system. Highleveldisinfectionisrequiredforequipmentthattoucheseithermucous membranesornonintactskin.Afterhigh-leveldisinfection,rinseallitems.Usesterile water,distilledorfilteredwater.Afterrinsing,dryandstoreinamannerthatprevents recontamination. Low-leveldisinfectionisrequiredfornoncriticalpatient-caresurfaces(treatmenttables, equipmenttrays)andequipment(e.g.,bloodpressurecuff)thattouchintactskin. Ensurethat,ataminimum,noncriticalpatientcaresurfacesaredisinfectedwhenvisibly soiledandonaregularbasis(suchasafteruseoneachpatientoroncedailydepending onthetypeofsurfaceandthefrequencyofuse). ReusablemedicalandAOMequipmentmustbedisinfectedbetweenuseonpatients.Thetable belowhasguidelinesfordisinfectingasdescribedinCDCmaterials. (http://www.cdc.gov/HAI/prevent/sd_medicalDevices.html) 3. Cleaning Equipment Reuse of Single-Use Medical Devices Thereuseofsingle-usemedicaldevicesdoesnotfollowbestpracticesforanAOMpracticefor devicesthatbreaktheskin.Beforethelate1970smostmedicaldevices(includingacupuncture needles)wereconsideredreusable.However,theAIDSepidemicandthegrowingawarenessof HBVinfectionassociatedwithreusingmedicalsharpsrenderedsuchuseunacceptableinthe U.S.Reuseofsingle-usedevicesinvolvesregulatory,ethical,medical,legalandeconomicissues. (12)Noacupuncturistshouldreuseneedlesorotherequipmentthatbreakstheskin. Pre-cleaning of Reusable Medical Equipment Cleaningistheremovalofforeignmaterial(e.g.,soilandorganicmaterial)fromobjectsandis normallyaccomplishedusingwaterwithdetergentsorenzymaticproducts.Thoroughcleaning isrequiredbeforelow-,intermediate-,orhigh-leveldisinfectionandsterilizationbecause inorganicandorganicmaterialsthatremainonthesurfacesofinstrumentsinterferewiththe 193 effectivenessoftheseprocesses.Also,ifsoiledmaterialsdryontotheinstruments,the disinfectionorsterilizationprocessisineffective. Instrument Cleaning ReusablemedicalandAOMequipmentmustbedisinfectedbetweenuseonpatients.See SafetyGuidelinesforDisinfectingReusableMedicalEquipmentasdescribedinCDCmaterials above.(http://www.cdc.gov/HAI/prevent/sd_medicalDevices.html) Safety Guidelines for Disinfecting Reusable Medical Equipment Sterility Categoryof Equipment: NonCritical Acupuncture Practice Examples BPcuff, Stethoscope,estimclips. Disinfectant LevelRequired beforeReuse Lowor intermediate disinfecting agents acceptable. Cupsorguasha Intermediate toolsusedover disinfecting intactskin. agents required. SemiCritical Allcupsused forwet cupping;cups andguasha spoonsusedon non-intactskin. Sterilizebefore reuse;orhighlevel disinfectant required. DisinfectingProcedure Fabricequipment(BPcuffs)maybe disinfectedwithisopropylalcohol EPAapprovedsolutionsfornoncriticalitems. Smoothsurfacescanbedisinfected through2steps:soapandwater cleansingfollowedbywipingwitha loworintermediatedisinfecting agent. Step1 Removalofallbiologicalandforeign material(e.g.,soil,organicmaterial, skincells,lubricants)fromobjects usingsoapandwater. Step2 SoakinappropriateFDA-cleared disinfectantforthetimeindicatedfor reusableequipment.Followlabel directionsforuseasanintermediate disinfectingagent. Step1 Removalofallbiologicalandforeign material(e.g.,soil,organicmaterial, skincells,lubricants)fromobjects usingsoapandwater. Step2 Option1:Autoclave. Option2:Soakinhigh-level disinfectant(e.g.,Sporox,Sterrad, Acecide,Endospore,Peract)asper productlabelinstructions. 194 Sterility Categoryof Equipment: Reusable Critical Sterility Critical; nonreusable Acupuncture Practice Examples Equipmentthat breakstheskin orentersthe vascular system;No AOM equipmentfalls inthiscategory. Needles,7-star hammers, lancets,press tacks,ear seeds. Disinfectant LevelRequired beforeReuse Mustbe sterilized. DisinfectingProcedure Cannotbe reused. Example:ethyleneoxidegas. Example:autoclave. Instrumentsusedinperforminginvasiveproceduresshouldbeappropriatelysterilizedpriorto use.AllinstrumentsthatentertheskinforAOMproceduresshouldbesingle-usepre-sterilized equipment. Equipmentanddevicesthatdonottouchthepatientorthatonlytouchintactskinofthe patientneedonlybecleanedwithalow-leveldisinfectantordetergent. Equipmentanddevicessuchascupsandguashatoolsthathavetouchedintactskin,butwhere thatskinhasbeensubjectedtocompressionshouldbecleanedwithatleastintermediatelevel disinfectants.Contaminatedequipmentthatisreusableshouldbecleanedofvisibleorganic materialbywashingandscrubbingwithsoapandwater,andthendisinfectedusingan intermediate-leveldisinfectingsolution(suchasCaviCide,Sterilox,Spor-Klenz,DisCide,orSuper Sani-Cloth).Wheneverthetoolswillbeplacedovernonintactskin(suchasincuppingafter needlingorwetcupping),theyneedtobetreatedassemi-criticalreusabledevices.Inthese cases,theequipmentneedstobecleanedwithsoapandwatertoremovethelubricant(if used)andbiologicalmaterialbeforedisinfectingwithanFDA-clearedhigh-leveldisinfecting solution(e.g.,Sporox,Sterrad,Acecide,Endospore,orPeract),orautoclaved. Thecurrentcontroversyisabouthowoftentheskinbarrieriscompromisedwhenusing equipmentsuchascupsandguashatools.Ina2014articleNielsenetal.maintains,“Guasha andBaguan[cupping]instrumentshavebeenmistakenasnon-criticalinstrumentsbecausethey appeartocontact‘intact’skin.However,thecontactisnotincidentalbutinvolvesenough repeatedorsustainedpressureasto(intentionally)causeextravasationofbloodandfluidsthat canseeporbeletfromtheskinevenifnotimmediatelyvisible.”(13)Morestudiesneedtobe 195 performedtodeterminehowfrequentlytheintactskinisdisruptedincuppingproceduresnot associatedwithbleedingandguashatechniques.Takingintoconsiderationthepotentialriskto patients,itistheeditor’sopinionthatisprudenttoconsiderhigh-leveldisinfectionofallcups andguashainstrumentsuntiladditionalstudiesarecompletedtodemonstratethedegreeto whichcuppingandguashacompromisetheskinbarrier.Havingonemethodofdisinfection increasesthepracticalconsiderationsthatthepractitionerwillalwayshavepreparedandbe usingdevicesthathavebeenproperlydisinfected. Wrappingorpackaginghelpstoidentifythatproperdisinfectionhasbeencompletedand preventscontactcontaminationthatmayoccurbydirectlyplacingthedeviceinatravelkitor onacounter. 4. Clean Use of Lubricants Lubricantsinopen-mouthjarscanbecomecontaminatedbythetransientbacteriafromthe practitioner’shands.Topreventthis,eitherusepumporsqueezebottlesoflubricantsforuse withcuppingorguasha,ordecantatreatment-sizedportionoflubricantintoasmall disposablecuporothercleandisposablecontainerusingacleantonguedepressororother cleandisposabledevicepriortostartingtheprocedure.Disposeofleftoverlubricantwithout returninganylubricanttotheprimarycontainer.Thispreventscontaminationoftheprimary lubricantcontaineranditscontents. 5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities • • • • • • Cleanhousekeepingsurfaces(e.g.,floors,tabletops)onaregularbasis(e.g.,daily,orat leastthreetimesperweek),whenspillsoccur,andwhenthesesurfacesarevisibly soiled. Followmanufacturers'instructionsforproperuseofdisinfectingproducts—suchas recommendeduse-dilution,materialcompatibility,storage,shelf-life,andsafeuseand disposal. Cleanwalls,blinds,andwindowcurtainsinpatient-careareaswhenthesesurfacesare visiblycontaminatedorsoiled. Decontaminatemopheadsandcleaningclothsregularlytopreventcontamination(e.g., launderanddryatleastdaily). Detergentandwaterareadequateforcleaningsurfacesinnonpatient-careareas(e.g., administrativeoffices). Donotusehigh-leveldisinfectants/liquidchemicalsterilantsfordisinfectionofnoncriticalsurfaces. 196 • • DisinfectnoncriticalsurfaceswithanEPA-registeredhospitaldisinfectantaccordingto thelabel'ssafetyprecautionsandusedirections. Promptlycleananddecontaminatespillsofbloodandotherpotentiallyinfectious materials(OPIM).Discardblood-contaminateditemsinthebiohazardcontainersasper compliancewithfederalregulations. Use of Disinfectants for Surface Cleaning Theeffectiveuseofdisinfectantsispartofanyhealthcaresettingstrategytopreventhealthcare–associatedinfections(HAI).Surfacessuchasfloorsanddoorhandlesareconsidered noncriticalitemsbecausetheycontactintactskin.Contactwithnoncriticalsurfacescarriesonly aminorriskofcausinganinfectioninpatientsorstaff,(14)primarilyHAIsuchasinfluenza. Medicalequipmentsurfaces(e.g.,bloodpressurecuffsandstethoscopes)canbecome contaminatedwithinfectiousagentsandmaycontributetothespreadofhealth-care– associatedinfections.Forthisreason,noncriticalmedicalequipmentsurfacesshouldbe disinfectedwithanEPA-registered(forsurfaces)/FDA-cleared(formedicaldevices)low-or intermediate-leveldisinfectant(e.g.CaviCide,Sani-Dex,DisCide,orSterilox)betweeneach patientuse. 6. Blood or Body Fluid Spills TheCDCrecommendsdecontaminationofspillsofbloodorotherpotentiallyinfectious materials(OPIM),usingthefollowingprocedures:(2) • • • • UseprotectiveglovesandotherPPE(e.g.,whensharpsareinvolvedusehemostatsto pickupsharps,anddiscardtheseitemsinapuncture-resistantcontainer)appropriate forthistask. Washtheareawithsoapandwaterfirst. Disinfectareascontaminatedwithblood/OPIMspillsusinganEPA-registered commercialhypochloritesolution.Followmanufacturer’slabeldirectionsforspillsbased onthetypeofsurface(porousornon-porous)andtheamountofbloodpresent. Ifthespillcontainslargeamountsofbloodorbodyfluids,cleanthevisiblematterwith disposableabsorbentmaterial,anddiscardthecontaminatedmaterialsinappropriate, labeledbiohazardouswastecontainer. Cleaningaccidentalspillsofbloodorbodyfluid(orOPIM)requiresathree-stepprocedure:(1) Usingrubbergloves,pickupthevisiblematterwithdisposableabsorbentmaterial;then(2) cleantheareawithadetergentsoapandwater;then(3)cleantheareaofthespillwithan approveddisinfectingsolutionappropriatetothetypeofsurfacebeingdisinfected.Useagown orimperviousapronifthereisariskofcontaminatingyourclothingduringtheclean-up.Where 197 theremaybeariskofsplashingoraverylargespill,safetyglassesandadisposableor sterilizableclothingprotectorshouldbeworn.Whendisinfectinganextensiveareawith disinfectingsolution,disposableglovesmaynotbeadequateandmayfailduringthe disinfectingprocess.Heavierglovesshouldbewornifthisisapossibility.Alldisposable materialsusedinthecleanupjobshouldbediscardedindoublewrappinginbiohazardbagsor containers;andhandsshouldbewashedattheendofthecleanup. Whencleaningaccidentalspillsofneedlescontaminatedwithblood,pickuptheneedlesusing glovesandhemostatsfirstanddiscardtheseintoanappropriatesharpscontainer,thenfollow thedirectionsabovetodealwiththebloodorOPIMspill. 7. Laundering Sheets, Towels or Other Linens Alllinens,gowns,etc.,mustbechangedbetweenpatienttreatments/visits.Thisincludesthe sheetsonatreatmenttable,evenifprotectedbyalayeroftablepaper.Unlessapatientisfully clothedinstreetclothesduringthetreatment,alllinensoranyothermaterialsuchasMylar “space”blankets,thatareusedoverthepatientfordrapingorwarmthmustalsobechanged betweenpatients. Clothgowns,sheets,etc.aresafeforreuseafterlaunderingwithhotwaterandsoapor detergent.Addinghypochlorite(bleach)solutiontothewashprovidesanextramarginof safety. Acupuncturepracticelocationsthatuseahighvolumeoflinensmaywanttoconsidertheuse ofacommerciallaundryfacilityforwashingtowelsandlinens.Commerciallaundryfacilities oftenusewatertemperaturesofatleast160°Fand50-150ppmofchlorinebleachtoremove significantquantitiesofmicroorganismsfromgrosslycontaminatedlinen.Inthehome,normal washinganddryingcycles,includinghotorcoldcycles,areadequatetoensurepatientsafety. Instructionsofthemanufacturersofthemachineandthedetergentorwashadditiveshouldbe followedclosely.(15) Commercialdrycleaningoffabricssoiledwithbloodalsorenderstheseitemsfreeoftheriskof pathogentransmission. 8. Sharps and Non-Sharps Biohazard Equipment and Disposal (Seealsohttp://www.cdc.gov/niosh/docs/97-111/andOccupationalSafetyandHealthActof 1970[OSHAAct]ortherequirementsof29CFR1910.1030,OccupationalExposureto BloodbornePathogens.) 198 Sharpscontainersmusteitherbelabeledwiththeuniversalbiohazardsymbolandtheword "biohazard"orbecolor-codedred.Sharpscontainersmustbemaintaineduprightthroughout use,replacedroutinely,andnotbeallowedtooverfill.Also,thecontainersmustbe: • • • • • Closedimmediatelypriortoremovalorreplacementtopreventspillageorprotrusionof contentsduringhandling,storage,transport,orshipping. Placedinasecondarycontainerifleakageispossible.Thesecondcontainermustbe: o Closable. o Constructedtocontainallcontentsandpreventtoleakageduringhandling, storage,transport,orshipping. Labeledorcolor-codedaccordingtothestandard. Reusablecontainersmustnotbeopened,emptied,cleanedmanually,orusedinany othermannerthatwouldexposeemployeestotheriskofpercutaneousinjury. Uponclosure,ducttapemaybeusedtosecurethelidofasharpscontainer,aslongas thetapedoesnotserveastheliditself. Sharpscontainersmustbeeasilyaccessibletoemployeesandlocatedascloseasfeasibletothe immediateareawheresharpsareused(e.g.,patientcareareas). Moststateshaveregulationregardingthetypesofsharpscontainersthatmaybeusedandthe appropriatedisposalofthesharpscontainers.Contactyourlocalhealthdepartmentforhelp understandingtheregulations,checkthewebsitehttp://www.safeneedledisposal.org/,or contactyourstate’sOSHAofficeforstate-specificdetails. 9. Regulated Waste TheBloodbornePathogensStandardusestheterm"regulatedwaste"torefertothefollowing categoriesofwastewhichrequirespecialhandling:(1)liquidorsemi-liquidbloodorOPIM;(2) itemscontaminatedwithbloodorOPIMandwhichwouldreleasethesesubstancesinaliquid orsemi-liquidstateifcompressed;(3)itemsthatarecakedwithdriedbloodorOPIMandare capableofreleasingthesematerialsduringhandling;(4)contaminatedsharps;and(5) pathologicalandmicrobiologicalwastescontainingbloodorOPIM. Inthetypicalacupuncturepractice,thereisrarelyanyregulatedwastebesidesthatwhichgoes inthesharpscontainer.(Itemstobedisposedinthesharpscontainerincludetheacupuncture needles,lancetsandplumblossomhammers.)Insometypesofpractice,thebloodfromwet cuppingwouldneedtobedisposedofinabiohazardbag,ratherthanthesharpscontainer. Also,anybloodspills,vomitorotherOPIMwouldbedisposedofinabiohazardbag. 199 Disposal Disposalofallregulatedwastemustbeinaccordancewithapplicablestateregulations.These rulesaretypicallypublishedbystateenvironmentalagenciesand/orstatedepartmentsof health.Inadditiontostaterulesfordisposingofregulatedwaste,therearebasicOSHA requirementsthatprotectworkers.TheOSHArulesstatethatregulatedwastemustbeplaced incontainerswhichare: • • • • • Closable. Constructedtocontainallcontentsandpreventleakageoffluidsduringhandling, storage,transportorshipping. Labeledorcolor-codedinaccordancewiththestandard. Closedpriortoremovaltopreventspillageorprotrusionofcontentsduringhandling, storage,transport,orshipping. Ifoutsidecontaminationoftheregulatedwastecontaineroccurs,itmustbeplacedina secondcontainermeetingtheabovestandards. Contaminated Laundry Contaminatedlaundrymeanslaundrywhichhasbeensoiledwithbloodorotherpotentially infectiousmaterialsormaycontainsharps. Contaminatedlaundrymustbehandledaslittleaspossiblewithaminimumofagitation;it mustbebaggedorcontainerizedatthelocationwhereitwasusedandmustnotbesortedor rinsedinthelocationofuse.OtherrequirementsoftheBBPstandard1910.1030(d)(2)include: (16) • • • • Contaminatedlaundrymustbeplacedandtransportedinbagsorcontainerslabeled andcolor-codedinaccordancewiththebloodbornepathogensstandard. Whenevercontaminatedlaundryiswetandpresentsareasonablelikelihoodofsoakthroughorleakagefromthebagorcontainer,thelaundryshallbeplacedand transportedinbagsorcontainerswhichpreventsoak-throughand/orleakageoffluids totheexterior. Theemployermustensurethatemployeeswhohavecontactwithcontaminated laundrywearprotectiveglovesandotherappropriatepersonalprotectiveequipment. Whenafacilityshipscontaminatedlaundryoff-sitetoasecondfacilitywhichdoesnot utilizeStandardPrecautionsinthehandlingofalllaundry,thefacilitygeneratingthe contaminatedlaundrymustplacesuchlaundryinbagsorcontainerswhicharelabeled orcolor-codedinaccordancewiththestandard. 200 • Employeesarenotpermittedtotaketheirprotectiveequipmenthomeandlaunderit.It istheresponsibilityoftheemployertoprovide,launder,clean,repair,replace,and disposeofpersonalprotectiveequipment. Summary of Recommendations – Part VI • • • • • • • • • • • • • • Critical:Allinstrumentsthatbreaktheskinshouldbesingle-usepre-sterilized equipment. Critical:Neverreusesingle-usemedicaldevices. Critical:Ifacustodialcontractorisresponsibleforclinicmaintenance,thecontractor mustbeinstructedregardingmaintenanceandthepresenceofbiohazardousmaterials. Critical:Asinkwithhotandcoldrunningwatermustbelocatedinornearthetreatment rooms. Critical:DisinfectsurfacesonlywithproductsregisteredwithEPAandlabeledforusein thehealthcareoffice. Critical:Cleanhousekeepingsurfaces(e.g.,floors,doorhandlesandlightswitches) immediatelywhenspillsoccur,andwhenthesesurfacesarevisiblysoiled. Critical:Promptlycleananddecontaminatespillsofbloodandotherpotentially infectiousmaterials(OPIM).Discardblood-contaminateditemsinthebiohazard containersincompliancewithfederalregulations. Critical:Cupsandguashaequipmentthathavebeencontaminatedandarereusable shouldbecleanedofvisibleorganicmaterial,thendisinfectedusingappropriate intermediate-orhigh-leveldisinfectingsolution,thenrinsedanddriedbeforebeing reused. Critical:Tablepaperanddrapingmustbechangedbetweeneachpatientvisit. Critical:Sharpscontainersmusteitherbelabeledwiththeuniversalbiohazardsymbol andtheword"biohazard"orbecolor-codedred. Critical:Sharpscontainersmustbemaintaineduprightthroughoutuse,replaced routinely,andnotbeallowedtooverfill. StronglyRecommended:Noncriticalmedicalequipmentsurfaces(e.g.,bloodpressure cuffs,treatmenttables)shouldbedisinfectedwithanEPA-registeredlow-or intermediate-leveldisinfectantbetweeneachpatientuse,followinglabeldirections. StronglyRecommended:Theclinicalworkplacemustbemaintainedinacleanand sanitaryconditionandtheremustbeanappropriatewrittenscheduleforcleaningand decontamination. StronglyRecommended:Thetreatmenttabletops,shelvesandotherworkingsurfaces shouldbecleanedwithasuitabledisinfectantatleastonceadayandwhenevervisibly contaminatedorwheneverapatientmayhavecontaminatedthesurfacebycomingin contactwiththesurfacedirectly. 201 • • • StronglyRecommended:Alllinens,gowns,etc.,mustbechangedbetweenpatient treatments/visits. Recommended:Thetreatmenttabletops,shelvesandotherworkingsurfacesshould haveasmooth,impervioussurfaceandbeingoodrepair. Recommended:Low-leveldisinfectantsshouldbeusedforcleaningofficesurfaces,not justdetergents. References 1.USCoastguard.BloodbornePathogens.http://www.coastusd.org/wordpress/wpcontent/uploads/bloodborne-pathogens1.pdf.AccessedJanuary2013. 2.CentersforDiseaseControl.HealthcareInfectionControlPracticesAdvisoryCommittee (HICPAC).GuidelineforDisinfectionandSterilizationinHealthcareFacilities, 2008.http://www.cdc.gov/hicpac/Disinfection_Sterilization/3_4surfaceDisinfection.html .AccessedJanuary2013 3.WeberDJ,RutalaWA.Occupationalrisksassociatedwiththeuseofselecteddisinfectants andsterilants.In:RutalaWA,ed.Disinfection,sterilization,andantisepsisinhealthcare. Champlain,NewYork:PolysciencePublications,1998:211-26. 4.MrvosR,DeanBS,KrenzelokEP.Homeexposurestochlorine/chloraminegas:reviewof216 cases.South.Med.J.1993;86:654-7. 5.R.E.D.Factssodiumandcalciumhypochloritesalts.EnvironmentalProtectionAgency.1991. http://www.epa.gov/oppsrrd1/REDs/factsheets/0029fact.pdf.AccessedJanuary2013. 6.DychdalaGR.Chlorineandchlorinecompounds.In:BlockSS,ed.Disinfection,sterilization, andpreservation.Philadelphia:LippincottWilliams&Wilkins,2001:135-157. 7.PerezJ,SpringthorpeS,SattarSA.Activityofselectedoxidizingmicrobicidesagainstsporesof Clostridiumdifficile:Relevancetoenvironmentalcontrol.Am.J.Infect.Control 2005;33:320-5 8.KleinM,DeForestA.Theinactivationofvirusesbygermicides.Chem.SpecialistsManuf. Assoc.Proc.1963;49:116-8 9.SattarSA,SpringthorpeVS.Survivalanddisinfectantinactivationofthehuman immunodeficiencyvirus:acriticalreview.Rev.Infect.Dis.1991 10.Rutala,William,DisinfectionandSterilizationinHealthCareSettings:WhatCliniciansNeed toKnow,CID2004:39,HealthCareEpidemiology. http://www.hpci.ch/files/documents/guidelines/hh_gl_disinf-sterili-cid.pdf.Accessed January2013. 11.SandersFT,MorrowMS.TheEPA'sroleintheregulationofantimicrobialpesticidesinthe UnitedStates.In:RutalaWA,ed.Disinfection,sterilizationandantisepsis:Principles, practices,challenges,andnewresearch.Washington,DC:AssociationforProfessionals inInfectionControlandEpidemiology,2004:29-41. 202 12.GreeneVW.Reuseofdisposabledevices.In:MayhallCG,ed.Infect.ControlandHosp. Epidemiol.Philadelphia:LippincottWilliams&Wilkins,1999:1201-8 13.NielsenA,KliglerB,KollBS.Safetyprotocolsforguasha(press-stroking)andbaguan (cupping).ComplementTherMed.2012;20(5)(October):340-344. 14.CentersforDiseaseControlandPrevention.GuidancefortheSelectionandUseofPersonal ProtectiveEquipment(PPE)inHealthcareSettings. http://www.cdc.gov/hai/pdfs/ppe/ppeslides6-29-04.pdf.AccessedDecember2012. 15.CentersForDiseaseControlandPreventionHealthcare-associatedInfections(HAIs). Laundry:WashingInfectedMaterial.CentersforDiseaseControl. http://www.cdc.gov/HAI/prevent/laundry.htmlReviewedJanuary27,2011.Accessed February2015. 16.OccupationalHealthandSafetyAdministration(OSHA).NeedlestickSafetyandPrevention Act.FrequentlyAskedQuestions.http://www.osha.gov/needlesticks/needlefaq.html. AccessedApril2013 203 Part VII: Office Procedures for Risk Reduction Thissectionaddressesfederalandotherlegalstandardsrequiredforambulatoryhealthcare offices.Thisinformationisnotmeanttoreplaceschooltraininginpracticemanagement,butto offeraresourceforpractitionerstolocatesourcesandexamplesforfederalstandardsfrom OSHA,CDCandothersources. Pleaseusethewebsitesreferencedhereinasneededtoidentifylegalstandardsandpractices thatapplytoyourofficeorclinic. Stateandlocalrulesandregulationsvary.Practitionersneedtokeepabreastofchangesinthe legallandscapeofhealthcarepracticeregulation. Riskreductionisatermusedtodescribeavarietyoftechniquesemployedtoreducethe likelihoodandconsequencesofanunintendedevent,namelyanaccidentthatmayresultinrisk toorinjuryofpractitioners,otherclinicemployees,orthepublic.Thesetechniques,policies, andproceduresmayberecommended,ormandatedbystatuteorrule.Regardlessoforigin, riskreductionisaprocessofreducingtheprobabilityofanunintendedeventcausinginjury, loss,orlegalactionthatbringsharmtotheproviderorotherindividuals.Riskreduction techniquesareforthemostpartcommonsense,whetherornottheyarerequiredbystatuteor rule,orarerecommended.ExamplesofriskreductiontechniquesincludetheuseofCNTand StandardPrecautionswitheverypatient.However,inadditiontocomplyingwiththespecific requirementsofacupuncturepracticeacts,practitionersmustcomplywithlocal,state,and federalstatutesregardinggeneralmedicalpracticesuchasinformedconsent,recordkeeping, patientconfidentiality,reportingofcommunicabledisease,andmaintenanceofanExposure ControlPlan.Additionally,theprovidermustcomplywithothersafetyrequirements,suchas: • HazardCommunicationStandardwithrespecttotoxicchemicalssuchasdisinfectants andotherchemicalssuchasisopropanolintheworkplace. • Firedepartmentregulationswithrespecttofireprotectionandelectricalsafety. • Buildingandsafetycodeswhenmodifyingaclinicorofficespace. • Stateandfederalstandardswithrespecttodocumentingsafety-relatedpoliciesand procedures. • Theproperdocumentationofaccidentsleadingtopropertyloss,injury,ordeath. • Safeandlegalinteractionwithpatientswhomaybeadangertothemselvesorothers. • Thepreventionofworkplaceviolence. 204 • Completionofallmandatedreportingwithregardtosafety-relatedincidents. Abroaddiscussionofthetopicofriskreductionisbeyondthescopeofthismanual.Thereader isreferredtoanappropriateriskreductiontextformoreinformation.Practitionersmustalso complywithallrequirementsmandatedbystatestatutesthatallownon-physician acupuncturiststopracticeacupunctureinthatstate.Theserulesincludecompliancewithstate orfederallawpertainingtoinformedconsent,recordkeeping,andpatientconfidentiality.This alsoincludestheHealthInsurancePortabilityandAccountabilityActof1996(HIPAA).Ethically, practitionersshouldpracticeinaccordancewiththesegeneralmedicalguidelines;nottodoso maycausepractitionerstobevulnerabletocivilandcriminalpenalties. Includedinthismanualisasummaryofsomeoftheprinciplesofriskmanagement,especially wheretheseideasaregermanetothepracticeofacupuncture.Thistextisnotintendedto replacecomprehensivetraininginanAOMprograminacupuncturerecognizedbythe AccreditationCommissiononAcupunctureandOrientalMedicine. 1. Federal Standards and Guidelines OSHA: Bloodborne Pathogens Standard OSHAhasdevelopedprocedurestohelphealthcareworkersprotectthemselvesfromavariety ofpossibleinfections,includingHBVandHIV.Ingeneral,theseprecautionsincludetheuseof anappropriatebarrier(gloves,gowns,masks,goggles,etc.)topreventcontactwithinfected bodyfluids.Additionally,standardsterilizationanddisinfectionmeasuresaswellasinfectious wastedisposalproceduresmustbefollowed. Thesepracticesareespeciallyimportantforallhealthcareprofessionalswhoparticipatein invasiveprocedures.Inadditiontogowns,gloves,andsurgicalmasks,protectiveeyewearor faceshieldsshouldbewornwherethegenerationofdropletsorthesplashingofbodyfluidsis possible.Iftheprotectivebarrierbecomestorn,itshouldbereplacedimmediatelyorassoonas patientsafetypermits.Intheeventofinjurytothehealthcarepractitioner,thebarriershould beremovedandthewoundtreatedpromptly.Anysuchinjuryshouldalsobefollowedupwith anincidentreport. Sincemedicalhistoryandexaminationcannotreliablyidentifyallpatientsinfectedwith HBV/HIVorotherbloodbornepathogens,infectionpreventionmethodsshouldbeused consistentlyforallpatients. Itisafactthatexposuretobloodbornepathogensposesasignificantrisktohealthcareworkers andtheirpatients.Thisexposurecanbeeliminatedorgreatlyreducedthroughworkpractice habits,personalprotection,training,vaccination,labeling,andmedicalsurveillance.(1) Therefore,twofederalagencieshaveestablishedstandardsthatapplytoallmedical 205 practitioners,includinglicensedacupuncturists.TheCDChasestablishedproceduresthatareto befollowedwithregardtooccupationalexposuretobloodbornepathogensinhealthcare settingsintheUnitedStates.TheseproceduresareknownasStandardPrecautions.OSHAhas codifiedtheCDCstandardsintorecommendationsthatapplytoallhealthcareproviders.The applicationofStandardPrecautionsandtheotherprotocolsthatconstitutethebestpractices foracupuncturistsintheUnitedStatesisreferredtoasCleanNeedleTechnique(CNT).Itis importanttorememberthattheapplicationofCNTinaclinicalsettingisathoughtfulprocess basedonanunderstandingofprinciplesratherthanaroteapplicationofmemorizedguidelines. Standard Precautions StandardPrecautionsinclude:1)handhygiene,2)useofpersonalprotectiveequipment(e.g., gloves,gowns,masks),3)safeinjectionpractices,4)safehandlingofpotentiallycontaminated equipmentorsurfacesinthepatientenvironment,and5)respiratoryhygiene/coughetiquette. (Seehttp://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standaredprecautions.html(2)formoredetails.)AllhealthcareworkersshouldadheretoStandard Precautions,includingtheappropriateuseofhandwashing,protectivebarriers,andcareinthe useanddisposalofneedlesandothersharpinstruments.Handsshouldbewashedbeforeand afterpatientcontact,andimmediatelyifhandsbecomecontaminatedwithbloodorotherbody fluids.Handsshouldalsobewashedafterremovinggloves.Healthcareworkersshouldcomply withcurrentguidelinesforhandwashingtoreducepossibletransientpathogenicorganisms frombeingpassedbetweenpatients.Instrumentsandotherreusableequipmentusedin performinginvasiveproceduresshouldbeappropriatelydisinfectedandsterilized.Gloves shouldbewornwheneverthereisapossibilityofcontactwithbodyfluids.(Bodyfluidstowhich standard/universalprecautionsapply:blood,serum/plasma,semen,vaginalsecretions, cerebrospinalfluid,vitreousfluid,synovialfluid,pleuralfluid,pericardialfluid,peritonealfluid, amnioticfluid,andwoundexudates.)Healthcareworkerswhohaveexudativelesionsor weepingdermatitisshouldrefrainfromalldirectpatientcareandfromhandlingpatient-care equipmentanddevicesusedinperforminginvasiveprocedures.Sharpobjectsrepresentthe greatestriskforexposures.Contaminatedneedlesshouldneverbebent,clipped,orrecapped. Immediatelyafteruse,contaminatedsharpobjectsshouldbediscardedintoapunctureresistantbiohazardcontainerdesignedforthispurpose.Needlecontainersshouldneverbe overfilled;containersshouldbesealedanddiscardedwhentwo-thirdstothree-quartersfull. NSPA TheNeedlestickSafetyandPreventionAct(NSPA)of2000givespractitionersandemployeesin healthcarefacilitiesthepowertoparticipateinselectingandevaluatingdevicesthatwouldbe mosteffectivefortheirownandtheirpatients’safety.Besidesrequiringtheuseofsafety- 206 engineeredneedlesandsharpsdevicesintheworkplace,NSPArequiresemployerstodevelop andupdateexposure-controlplansannually. BBPstandard1910.1030(d)(2)incorporatestheNSPAasan“amplification”ofOSHAstandards: [CPL2-2.69]“Whereexposurestobloodandotherpotentiallyinfectiousmaterials(OPIM)are reasonablyanticipatedandengineeringcontrolswillreduceemployeeexposureeitherby removing,eliminating,orisolatingthehazard,theymustbeused...Ifyouhavenotalready evaluatedandimplementedappropriateandavailableengineeringcontrols(safermedical devices),youmustdosoimmediately...and...theevaluation,implementation,anduse.. .mustbedocumentedintheemployer'sExposureControlPlan.”(3) Thoseusingtherapeuticneedlingtechniques,bleedingtechniquesandothertypesofsharp instrumentsinhealthcaresettingsmustevaluatetheircurrentuseofthesedevices.Employers andemployeesinhealthcaresettingsneedtoevaluateiftheycanshiftfromconventionalto safety-engineereddevices(suchasauto-lancetsforbleeding)baseduponbestpractices. Seehttp://www.osha.gov/needlesticks/needlefaq.htmlformoreinformationaboutNSPA. OSHA: Exposure Control Plan Employersofhealthcareworkersareencouragedtoparticipateinthetaskofcontrollingrisksin theworkplace,includingthespreadofblood-bornepathogenssuchasHBV/HIV,by disseminatingpreventiveinformationintheworkplacethroughadetailedexposurecontrol plan(ECP).Eachemployerhavinganemployee(s)withoccupationalexposuremustdevelop suchaplandesignedtoeliminateorminimizetheincidenceofemployeeexposureto workplacerisks. Practitionerswhohaveemployees,whethertheybeareceptionistoracustodian,whomaybe exposedtobloodbornepathogensbypullingneedles,emptyingthetrash,assistingpatientsin dressingandundressing,shouldhaveanECP.ThisECPmustincludeinformationabout preventingthespreadofBBP,includingavailabilityofHBVvaccination,forallworkersinan acupuncturist’semploywhomaycomeincontactwithbloodorOPIM.Practitionerswhoshare officespacewithotherpractitioners,includingatreatmentroomorstorageareafor biohazardouswaste,mustalsodevelopanECP. Allhealthcarepracticesmustcreate,maintain,updateandtrainallpersonnel(includingthe owner/acupuncturist)onpossibleexposurestoinfectiousagentsandotherhazards.Training musttakeplacebeforepersonnelmaybeexposedtohazardsandagainannually.Allhealthcare facilitiesmustmaintainanExposureControlPlanforBloodbornePathogens(BBP)aswellasa HazardousCommunicationPlanforchemicalexposures.(4) Anexposurecontrolplan(ECP)forBBPconsistsof: 207 1. WRITTENPOLICIES(Includingtheplan) 2. PROGRAMADMINISTRATION(Nameofresponsibleofficerforpolicies,training,and reports) 3. EMPLOYEEEXPOSUREDETERMINATION(Listofemployeetitlesofthosethatmay becomeexposed;includesanyonewhotreatspatientsorentersatreatmentroom whereinalooseneedlemaybefound.) a. Alistofjobclassificationswhereallemployeeshaveoccupationalexposure. b. Alistofjobclassificationswheresomeemployeeshaveoccupationalexposure. c. Alistofalltasksandprocedures(orcloselyrelatedgroupsofactivities)inwhich occupationalexposureoccurs. 4. METHODSOFIMPLEMENTATIONANDCONTROL a. ExposureControlPlan. b. EngineeringControlsandWorkPractices:Includesrequirementsfor handwashingfacilities,sharpscontainment,maintenanceanduseofworkareas, proceduresinvolvingbloodorpotentiallyinfectiousmaterials,andhandlingof equipmentthatmaybecomecontaminated. c. PersonalProtectiveEquipment(PPE):Coverstheprovisionanduseofitemssuch asgloves,gowns,masks,andotherpiecesofclothingorequipmentwhen occupationalexposureispossible.Latex-freeglovesmustbeprovidedifan employeeisallergictolatex. 5. REGULATEDWASTE a. Housekeeping:Includesrequirementsformaintainingtheworksiteinacleanand sanitarycondition. b. Sharpscontainmentanddisposal. c. Laundry:policiesandproceduresforcleaningalllaundryandpoliciesfor handlingcontaminatedlaundry. d. Labels:forallcontainerswhichmayhavecontaminatedwasteorsharps. e. Disposalofbiohazardmaterialsandcontaminatedwaste. 6. HEPATITISBVACCINATION 7. POST-EXPOSUREEVALUATIONANDFOLLOW-UP a. Administrationofpost-exposureevaluationandfollow-up. b. Proceduresforevaluatingthecircumstancessurroundinganexposureincident. 8. EMPLOYEECOMMUNICATION:Includesstandardsforlabelsandsignssuchasbiohazard labelsandwarningsigns,containers,andbags. 9. EMPLOYEETRAINING a. NewemployeesmustbeofferedahepatitisBvaccineandreceivebloodborne pathogeneducationbeforehavingcontactwithbloodorbodyfluids. b. AllemployeesmustreceiveannualtrainingregardingtheOSHABBPstandard. 208 10. RECORDKEEPING a. Employeetraining(maintainforatleast3yearsafterthedurationof employment). b. Medicalrecordsofthoseexposed(maintainforthedurationofemployment PLUS30years). c. OSHARecordkeeping(maintainforaminimum5years). d. SharpsInjuryLog(logisreviewedaspartoftheannualprogramevaluationand maintainedforatleastfiveyearsfollowingtheendofthecalendaryear covered). 11. HEPATITISBVACCINEDECLINATIONSTATEMENT/POLICY(maintainforthedurationof employmentPLUS5years) TheECPshouldalsoprovideascheduleandmethodsforimplementingprecautionprocedures, andproceduresforevaluatingexposureincidents.Acopyoftheplanmustbemadeavailableto allemployees.Theplanmustbereviewedandupdatedannually,orwheneverneworrevised tasksorproceduresareaddedtothepractice,orifnewpositionsarecreatedthatmayhave exposurepotential. SampleECPsforBBPcanbefoundhere: • • • http://www.osha.gov/Publications/osha3186.pdf(pdfversion) http://www.osha.gov/Publications/osha3186.html(htmlversion) http://www.osha.gov/OshDoc/Directive_pdf/CPL_2-2_69_APPD.pdf(specificsmall businessplanversion) OSHAdocumentsrelatingtoECPsinclude: • • http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=1574&p_table= DIRECTIVES http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p _id=10051 AmodelBBPECPandamodelHazardousCommunicationdocumentcanbothbefoundin thefollowingOSHApublication: • http://www.osha.gov/Publications/osha3186.pdf AdditionalinformationforthoseworkinginCaliforniacanbefoundhere: • http://www.dir.ca.gov/dosh/dosh_publications/expplan2.pdf AsampleECPforTBcanbefoundhere: 209 • http://www.osha.gov/SLTC/etools/hospital/hazards/tb/sampleexposurecontrolplan. html OSHA: Hazardous Communication http://www.osha.gov/dsg/hazcom/index.html(5) Inordertoensurechemicalsafetyintheworkplace,informationabouttheidentitiesand hazardsofthechemicalsmustbeavailableandunderstandabletoemployees.OSHA'sHazard CommunicationStandard(HCS)requiresthedevelopmentanddisseminationofsuch information.Allemployerswithhazardouschemicalsintheirworkplacesmusthavelabelsand safetydatasheetsfortheirexposedworkers,andtrainthemtohandlethechemicals appropriately.Thisincludesallhealthcare/acupuncturepracticesettingsastheuseofsuch chemicalsforcleaninganddisinfectingfallsintothisstandard. AHazardousCommunicationPlanconsistsof: 1. CompanyPoliciesregardingchemicalexposures–writtenrecords 2. ContainerLabeling–Listsoflabelsandplansforlabelingofchemicalsafterbeingputin newcontainersorchanges 3. ChemicalList–Listofallhazardouschemicalsfoundatthepracticelocation.Thiswill includecleaningsolutions,alcoholforswabbing,andhandcleaningsolutions 4. MaterialSafetyDataSheets(MSDSs) 5. EmployeeTrainingandInformation 6. HazardousNon-RoutineTasks(list) 7. PoliciesregardingInformingOtherEmployers/Contractorswhomayenterthepremises (e.g.,outsidecleaningagencies) 8. Howtheemployerhastrainedandmadethispolicyandprogramavailabletoemployees AsampleHazardousCommunicationpolicycanbefoundhere: http://www.osha.gov/Publications/osha3186.html Anexcellentchecklistandmorereadableexplanationoftherequirementscanbefoundhere: http://www.lni.wa.gov/IPUB/413-012-000.pdf WhiletheabovechecklistisfromtheWashingtonStateoffices,theinformationcanbeusedfor allacupuncturistslookingtocomplywiththeHazardousCommunicationStandard. 210 OSHA: Other Hazards Duetotheuseofmoxa,standardsregardingindoorairqualityandfiresafetyapplytomost AOMpracticelocations.Alistofthestandardsandtheirapplicationsshouldbereviewedbythe practice’ssafetyofficerannually.OSHAstandardscanbefoundhere: Fire: • • • http://www.osha.gov/SLTC/firesafety/index.html http://www.osha.gov/SLTC/etools/hospital/hazards/fire/fire.html http://www.osha.gov/Publications/laboratory/OSHA3403laboratory-safetyguidance.pdf Indoorairquality:http://www.osha.gov/dts/osta/otm/otm_iii/otm_iii_2.html#5 Theuseofelectricalequipmentisregulatedbyvariousstateandfederalstandards.Those utilizingheatlamps,electroacupuncture,andanyelectricalequipment(computers,fax machines,etc.)needtohavesomepoliciesinplaceformeetingthesestandards.Alistofthe standardsandtheirapplicationsshouldbereviewedbythepractice’ssafetyofficerannually. OSHAstandardscanbefoundhere: • • http://www.osha.gov/SLTC/electrical/index.html https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGI STER&p_id=19269 Practitionersshouldcontacttheirlocalhealthdepartmenttoobtainfurtherinformation regardingOSHAtrainingandstate-ortown-specificrequirementsforhealthcareoffices. Notethatonceyouhaveidentifiedtheexistingandpotentialhazardsinyourtreatment location,yourstateOSHAConsultationProgramcanhelpyouimplementthesystemsthat preventorcontrolthosehazards.Thestateconsultationprogramisfreeforallemployersand havingthestateinspectyourpracticesettingwillnotresultinafine,evenifallstandardshave notbeenmet.Usually,youwillhave90daysafterreceivingareportfromyourstate consultationtocreateaplantoaddressalldeficiencies.Utilizingthisserviceisagreatwayto preventproblemsinthefuture. OSHA: Disposing of Biohazardous Waste Whendiscussingbiohazardouswaste,thefollowingtermsareapplicable: Biohazardouswaste:Anysolidwasteorliquidwastethatmaypresentathreatofinfectionto humans(includingnon-liquidhumantissueandbodyparts),laboratorydisease-causingagents, discardedsharps,humanblood,orclinicwastesuchastablepaperorcottonballsthatcontain 211 humanblood,humanbloodproducts,orbodyfluids.(Note:OSHAhasdeterminedthatacotton ballcontainingenoughbloodthatitcanbewrungoutmustbeclassifiedasmedical,or biohazard,waste;lessthanthatamountonacottonballmeansthatitshouldbeconsidered trash.OSHAreferstobiohazardouswasteas“regulatedwaste.”)(5) Biohazardouswastegenerator:Afacilityorpersonthatproducesorgeneratesbiohazardous wasteincludingawiderangeoffacilitiesfromhospitalstomedicaloffices,fromveterinary clinicstofuneralhomes.(6)Licensedacupuncturistsareincludedinthiscategory. OSHAhasenactedspecificrulesconcerningthehandlinganddisposalofbiohazardousor infectiouswasteinordertoeliminatetheexposureofemployees,patients,andthepublicto disease-causingagents.Theserulesrequire: 1. Wastegeneratorsmustprepare,maintain,andimplementawrittenplantoidentifyand handlesuchwaste.Anyemployeewhoworksinanareawherebiohazardouswasteis keptmustbeprovidedwithanemployeetrainingprogramthatexplainsproceduresfor on-siteseparation,handling,labeling,storage,andtreatmentofbiohazardousmaterials. 2. Biohazardouswaste,exceptsharps(devicescapableofpuncturing,lacerating,or penetratingtheskin),mustbepackagedinimpermeable,red,polyethyleneor polypropylenebags(“redbags”),andsealed. 3. Discardedsharpsmustbeseparatedfromallotherwasteandplacedinleak-resistant, rigid,puncture-resistantbiohazardcontainers.Allcontainersmustbelabeledproperly, especiallyifthetreatmentanddisposalaretotakeplaceoff-site. 4. Instoringthepackagedwaste,caremustbetakentoplaceitinadesignatedareaaway fromgeneraltrafficflowandaccessibleonlytoauthorizedpersonnel.Oneoptionisto storebiohazardouswasteawaitingpickupinalockedclosetnotusedforstorageof cleanitemsorfood. Allwasteshouldbedisposedofbyremovalbyamedicalwastedisposalcompany.Donotthrow medicalwasteintothetrashforremoval.Thisisespeciallytrueforsharpswhichposeahazard tocustodialandwasteremovalpersonnel.OSHAregulationscontainminimumstandards establishedbythefederalgovernment.However,stateandlocalregulationsarepermittedto be,andoftenare,morestringent,regardingthedisposalofhazardouswaste.(7,8)Thesewaste lawsdiffergreatlyfromstatetostateandmayvaryatthecountyandevenmunicipallevel.For example,somecity,county,orstategovernmentsrequireapermitandinspectionforalloffices thatgeneratehazardouswaste.Othersrequirethatusedneedlesandothercontaminated wastebepickedupbyalicensedcontaminateddisposalservice(andmayrequireproofsuchas avalidcontractandreceiptsofpickupanddisposalheldbyanacupuncturist).Stillothers requireapermittotransportcontaminatedwastewhichmaypreventapractitionerfrom carryingasharpscontainerinatravelkitunlessaspecialpermitisacquired.(9)Itisimportant 212 tobethoroughlyfamiliarwiththeregulationsinyourlocality.Thestateorcountypollution controlagencyand/orhealthdepartmentisthebestsourceforinformationand recommendations.Wheneverpossible,itisadvisabletohavehazardouswastetransportedby anapprovedcarrier. Discarding gloves, cotton balls and other material contaminated with blood OSHAdefinesregulatedwasteas:liquidorsemi-liquidbloodorotherpotentiallyinfectious materials(OPIM);contaminateditemsthatwouldreleasebloodorOPIMinaliquidorsemiliquidstateifcompressed;itemsthatarecakedwithdriedbloodorotherpotentiallyinfectious materialsandarecapableofreleasingthesematerialsduringhandling;contaminatedsharps; andpathologicalandmicrobiologicalwastescontainingbloodorotherpotentiallyinfectious materials.(10) Gauze,cottonballs,gloves,etc.thatareusedduringthepatientvisit,butarenotsaturatedor soakedwithbloodorOPIM,canbediscardedinregularwaste.Anyoftheseitemsthatare saturatedwithbloodsuchthattheywouldreleasebloodorOPIMduringroutinehandlingof thetrashmustbediscardedinredbiohazardouswastebags. What should patients do with press tacks or other imbedded devices that they need to remove at home? Safesharpsdisposalisimportantwhetheryouareathome,atwork,atschool,traveling,orin otherpublicplaces.Asof2004,theFDA/CDCnolongerallowssimpletrashdisposalof biohazardsharpsathome(includinglancetsfordiabetics).Allsharpsmustbedisposedof throughapropersharpscontainerormail-backprogram.Whenusingpresstacks/intradermal needles,eitherhavethepatientwiththeintradermalneedlesandpresstacksstillimbedded returntothepractitionerforproperremovalanddisposal;(7)orthepatientcanbegivena sharpscontainertotakehome,useitforintradermalneedleswhenremovedathome,and thenthesharpscontainerwouldneedtobereturnedtothepractitionerforproperdisposal.(6) Seethewebsiteslistedbelowformoreinformation: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealth andConsumer/ConsumerProducts/Sharps/UCM278775.pdf http://www.cdc.gov/niosh/topics/bbp/disposal.html http://www.hercenter.org/osha.cfm Thebestpractice(safestoption)whensendingapatienthomewithpresstacksorothersharps istoprovidethemwithasmallsharpscontainer.Oncethepatientremovesthepresstacks,he orsheshoulddiscardtheminthesharpscontainerandthenbringthecontainerbacktothe practicelocationathisorhernextvisit. 213 2. Safety Considerations Regarding the Practice Environment Acupuncturistsmustconducttheirpracticeinsuchawayastoensure,sofarasisreasonably possible,thatpersonswhomayenterthepracticeenvironmentarenotexposedtorisksto theirhealthorsafety.Thisdutyextendstobothpatientsandemployees.Itisbyfollowing recognizedstandardsestablishedbyOSHAthatthisdutycanbefulfilled.Inparticular,attention shouldbefocusedonthefollowing: 1. Allfloors,passages,andstairsshallbeofsoundconstruction,properlymaintained, andshouldbekeptfreefromobstructionandfromanysubstancelikelytocause personstoslip. 2. Asubstantialhandrailandadequatelightingshouldbeprovidedforeverystaircase. 3. Adequatelightingmustbeprovidedandmaintainedinallofficespaces. 4. Allstructuresandequipmentshouldbesubjectedtoregularinspectionand preventativemaintenance. 5. Allelectricalinstallationsshouldbeinaccordancewithlocalcodes. 6. Everychair,seat,orcouchonthepremisesshouldbekeptcleanandmaintainedin properrepair. 7. Floorsshouldbeeasilycleaned.Carpetinginareaswherebiohazardouswasteis generatedorstoredisnotrecommendedsinceitisdifficulttocleanupspilled needlesorfluids. 8. Allmodificationstotheclinicshouldbedoneinsuchamannerthatallconstruction, plumbing,andwiringmeetlocalconstructioncodesandaredoneinacompetent andsafemanner. 9. Allfireextinguishers,firesprinklersystems,andotherfiresafetyequipmentshould bemaintainedaccordingtothemanufacturer’sinstructionsandlocalfire regulations. 10. Thelocationofhandwashingfacilities,sharpscontainers,biohazardcontainers,and theavailabilityofsafetyequipmentshouldbesuchthatthesematerialsarereadily availabletotheacupuncturistintheworkplace. 11. Allprovidersandotherclinicpersonnelshouldknowwherematerialsafetydata sheetsandsafetymanualsarelocatedandhaveaccesstothemonademandbasis. PractitionersshouldalsoconsultOSHArequirements,Section3(EngineeringControlsandWork PracticeControlsRegulations,Standards–29CRF,1910.1030d2)forprovisionsregarding maintenanceanduseofworkareasandsigns.Othersourcesofinformationregardingaproper officeenvironmentforthepracticeofacupunctureshouldalsobeconsulted. 214 3. Recordkeeping Charting General Charting Considerations Patientrecordsshouldbekeptofallpatientvisitsandtreatmentsperformed.Thetreatment recordshouldbeacomplete,accurate,up-to-datereportofthemedicalhistory,condition,and treatmentofeachpatient. Treatmentrecordsaremaintainedprimarilytoprovideaccurateandcompleteinformation aboutthecareandtreatmentofpatients.Theyaretheprincipalmeansofcommunication betweenhealthpractitionersinmattersrelatingtopatientcareandserveasabasisfor planningthecourseoftreatment.Theyarealsothepractitioner’srecordofwhatoccurredif thereisacomplaintorlawsuit.Legislationandregulationsconcerningmedicalrecordsvary fromstatetostate.Manystatesrequiremedicalrecordstobekeptforaspecificlengthoftime aftertreatment.Somestatesdetailtheinformationrequiredconcerningthepatient’s treatment.Otherssimplydeclarethatthemedicalrecordshouldbeadequate,accurate,or complete.Allpatientrecordsshouldbecompletedinblackink,becompletewithrespecttothe datafromthepatientcontact,andnotbeerasedorotherwiserenderedillegibleafterthe patientcontact.Intheeventthepractitionerwishestomakeachangeintherecordduringa treatment,suchasdecidingnottouseaspecificpoint,ifthepractitionerutilizespaperrecords, theacupuncturistshoulddrawonelinethroughthetextinquestion,initialthechange,and thenrecordtheupdatedinformation.Donotscratchoutorrenderillegibleanyinformation recordedinachartnote. Patientrecordsmustbeprotectedagainsttheft,fireorwaterdamage.Eachofficeshouldset policiesandimplementproceduresthatwillpreventthelossofpatientrecords,whether electronicorpaper-based. Thereareninecriticalpartsofanychart.Theseare: 1. 2. 3. 4. 5. 6. Patientinformation Pastmedicalhistory Allergiesandadversereactions Familyhistory Datedandsignedrecordsofeveryvisit Flowsheetsfororganizationofhealthmaintenance,chronicconditions,wellcarevisits,etc. 7. Narrativenotesdescribingconversationswithpatientsregardingtreatments (acceptedandrefused)andpreventativetesting 215 8. Consentdocumentation 9. Flowsheetsornarrativesindicatingthatunresolvedproblemsfromprevious officevisitsareaddressedinsubsequentvisits Treatmentrecordsarelegaldocumentsandarethereforerequiredtomeetcertainstandards. Somebasicstandardsforchartinginclude: • • • • • • • • • • Dateofthevisitshouldbeincludedonallentriesintotherecord.Thedatemustappear immediatelyabovethefirstentryforeachvisitorprocedure.Also,thedatemustbeon everypageofachartforanyoneday’sinformation,includingfrontandbackofthe samepage,sothatifrecordsneedtobecopied,allpagesareclearlyidentified. Aperson'sfullnameandotheridentifiers(i.e.,medicalrecordnumber,dateofbirth) shouldbeincludedonallrecords.Theseidentifiersmustbeoneverypageofachart, includingfrontandbackofthesamepage,sothatifrecordsneedtobecopied,allpages areclearlyidentified. Continuedrecordsshouldbemarkedclearly(i.e.,ifanoteiscontinuedonthereverse sideofapage). Eachpageofdocumentationshouldbeinitialed(includingbothsidesofarecord)witha fullsignatureonthelastpageoftherecord;andeachprogressnotemustbesigned. Blueorblacknon-erasableinkshouldbeusedonhandwrittenrecords. Recordsshouldbemaintainedinchronologicalorder. Disposalorobliterationofanyrecordsorportionsofrecordsshouldbeprevented.This includestakingreasonableprecautionstohaverecordsprotectedfromfireandwater damage,aswellastheft. Documentationerrorsandcorrectionsshouldbenotedclearly,i.e.,bydrawingoneline throughtheerrorandnotingthepresenceofanerror,andtheninitialingthearea.All suchcorrectionsshouldbemadesothatareadercanvisiblyseewhatwaschanged, whochangedit,andwhenthecorrectionwasmade.WhenutilizingElectronicHealth Records(EHR)thesystemshouldbeonethatsimilarlyidentifieschanges(andclearly markswhenthechartwaschangedandbywhom). Excessemptyspaceonthepageshouldbeavoided.Ifapaperchartisbeingutilized,a lineshouldbedrawnthroughanyunusedspaceandinitialedwiththetimeanddate included. Alleventsinvolvinganindividualshouldbedescribedasobjectivelyaspossible,i.e., describeapatient’sdemeanorbysimplystatingthefactssuchaswhatthepersonsaid ordidandsurroundingcircumstancesorresponseofstaff,withoutusingderogatoryor judgmentallanguage. 216 • • • • Anyoccurrencethatmightaffectthepersonshouldbedocumented.Documented informationisconsideredcredibleincourt.Undocumentedinformationisconsidered questionablesincethereisnowrittenrecordofitsoccurrence. Ifanoteisaddedafterthecompletionofavisit,itshouldbelabeledasanaddendum andinsertedincorrectchronologicalorderratherthantryingtoinserttheinformation onthedateoftheactualoccurrence. Actualstatementsofpeopleshouldberecordedinquotes. Thechartshouldnotbeleftinanunprotectedenvironmentwhereunauthorized individualsmayreadoralterthecontents. Itisrecommendedthatacupuncturistsfollowstandardmedicalchartingproceduressuchasthe SOAPnotes: 1. Subjective(informationreportedbythepatient). 2. Objective(informationgatheredbythepractitioner,i.e.,tongue,pulse,palpation). 3. Assessment(ofthepatient’sconditionandtreatmentprogress). 4. Plan(treatmentrecordfortheday,includingpoints,herbs,dietaryandlifestyle recommendations,newdiagnosisandreferral,ifany). Standard Requirements for AOM charting A. Subjective: 1. Recordpersonalprofileinformationsuchasdemographics,self-careknowledge, skillsandattitudes. 2. Recordcurrentandpastsupplements(herbalandvitamins),prescriptionsandOTC medications. 3. Collectionofhealthhistorydataincludingsomeorallofthe“10questions” a. EnergyandSleep b. Head,Eyes&Ears c. Chest&Abdomen d. Stool&Urine e. Thirst,Appetite&TastePreferences f. Menses g. Pain(OPPQRST) h. Hot&ColdPreference i. Perspiration j. EmotionalIssues/Stressors 4. Recordrecentconsultationswithotherhealthcareproviders B. Objective:Performaclinicalevaluationwhichincludes: 1. BP,pulserate 2. TCMPulsedx 217 3. Tongue 4. Palpationsofareasofpain/dysfunction 5. Mayalsoadd: i. pointpalpation,Mupointpalpation,jointROM,reflexes ii. informationrelatedtothelisteningandsmellingexams iii. constitutionassessment/eyediagnosis/facialdiagnosis,skin,hair,nail diagnosis iv. abdominaldiagnosis v. organ-specificfindings vi. neuromuscularexamfindings vii. otherbiomedicalexamfindings Example:BP110/76,P68,R12.Tonguelong,wide,redwithathinwhitecoatand distendedsublingualveins.Pulse:regularrateandrhythm,full,thinandwiry. ShoulderROMdecreasedinabductionto110degreesontheright;175degrees ontheleft.SpecificpointtendernessnotedatGB21,SJ14,15ontherightonly. C. Assessment: 1. AnalyzeandinterpretallassessmentdatatoevaluatefindingsfromaTCM perspective. 2. Dependingonthelocalandstateacupuncturestatutes,thismayalsoincludea biomedicaldifferentialdiagnosis(ICDcodingasappropriate). 3. DeterminewhetherpatientneedscanbeimprovedthroughthedeliveryofAOM modalities. Example:QiandBloodstagnationintheGBandSJchannels.Shoulderpain previouslydiagnosedasarotatorcuffstrain/sprain(ICD9840.4).Improvementfrom acombinationofacupuncture/moxibustionandcuppinglikelyafter4-6treatments. D. Plan:Planningistheestablishmentofgoalsandoutcomesbasedonpatientneeds, expectations,values,historicaltexts,currentscientificevidenceandothersourcesof evidence.Treatmentrecordshouldincludethespecificpointsstimulated,modalities appliedtopoints(needle,moxa,guasha,electricalstimulation,cupping,etc.),dietary andlifestylerecommendations,andanyneedforreferralorconsultations.Itmay includeinformationabouthomecare/self-care.Itmayincludeprognosisortreatment planningforaseriesofthesameorsimilartreatment.Ifbillinginsurance,includeCPT codes. Dailytreatmentrecordsshouldincludethetreatmentprinciple(s),pointsandtreatment proceduresforeachvisit,forexample:RelievestagnationofqiintheGBandSJchannels oftherightshoulder.NeedleandindirectpolemoxaonGB21,34;electricalstimulation SJ14-15(bilaterally).CPTCodes:99212,97813. 218 Implementation:ReviewandimplementtheAOMplanwiththepatient.Modifythe planasnecessaryandobtainwrittenconsent.Confirmtheplanforcontinuingcare. Example:Treatmenttoberepeatedweeklyfor4weeksthenreassessandreevaluate progressbeforeadditionaltreatmentsoffered. Daily Appointment Schedules Treatmentrecordsmustbemaintainedasperstatelaw.Inaninvestigationofanoutbreak, particularlyofhealthcareassociateddiseasessuchasHBV,nothingismoreimportantthan keepinganaccuraterecordofnamesandaddressesofallpatientsanddatesoftreatments. SincehepatitisBhasalongandvariedincubationperiod,lackofrecordedinformationabouta patient’streatmentatrelevanttimesmaypreventtheproperinvestigationofanycrossinfectionrelatedtoHBV. 4. Patient Confidentiality Practitionersshouldbeawarethatasageneralruletheymaynotreleaseinformationregarding apatient,eitherverballyorinwriting,withoutthepatient’sconsent.Practitionersmay, however,discusscaseswithotherhealthcareprofessionalssolongasthereisnoidentifying informationprovided.Inadditiontostateconfidentiallystatutes,mostacupuncturistsmust nowcomplywiththeHealthInsurancePortabilityandAccountabilityAct(HIPAA).Thereaderis referredtothisactformoredetails;seeinformationbelow. HIPAA Health Information HIPAAinformationcanbelocatedat:http://www.hhs.gov/ocr/privacy/ HIPAAincludestheconfidentialityprovisionswhichapplytomanyhealthproviders.TheHIPAA SecurityRuleestablishesnationalstandardstoprotectapatient’spersonallyidentifiable information.“TheSecurityRulespecifiesaseriesofadministrative,physical,andtechnical safeguardsforcoveredentitiestousetoassuretheconfidentiality,integrity,andavailabilityof electronicprotectedhealthinformation.” ManyacupuncturistsarecoveredbyHIPAA.Youarea“coveredentity”ifyouconductcertain businesselectronically,suchassendingemailstootherhealthpractitioners,electronically billinghealthinsurancecompanies,orfaxinginformationtootherswhoarecoveredbyHIPAA. TofindoutifyouareaHIPAA“coveredentity”refertohttp://www.cms.gov/Regulations-andGuidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/AreYouaCoveredEntity.html. AsummaryoftheHIPAAprivacyrulesthatapplycanbefoundhere: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf. 219 Additionalcomplianceinformationcanbeaccessedatthefollowingsites: HIPAAandYou:BuildingaCultureofCompliance http://www.medscape.org/viewarticle/762170. HHSInformation:http://www.hhs.gov/ocr/privacy/. And:http://www.wedi.org/workgroups/security-privacy. ProtectedHealthInformation.TheHIPAAPrivacyRule (http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/)protectsall"individually identifiablehealthinformation"heldortransmittedbyapractitioneroritsbusinessassociate, inanyformormedia,whetherelectronic,paper,ororal.ThePrivacyRulecallsthisinformation "protectedhealthinformation(PHI)."Protectedinformationincludes:theinformation healthcareprovidersputinamedicalrecord;conversationsaboutpatientcareortreatment withotherhealthprofessionals;specifichealthinsurerinformation;andpersonalbilling information. ThePrivacyRuleprovidesthatanindividualhasarighttoadequatenoticeofhowapractitioner mayuseanddiscloseprotectedhealthinformationabouttheindividual,aswellashisorher rightsandthepractitioner’sobligationswithrespecttothatinformation.Mostclinical practitionersmustdevelopandprovideindividualswiththisnoticeoftheirprivacypractices (NOPP). ContentofaNOPP:Practitionersarerequiredtoprovideanoticeinplainlanguagethat describes: • • • • • Howthepractitionermayuseanddiscloseprotectedhealthinformationaboutan individual. Theindividual’srightswithrespecttotheinformationandhowtheindividualmay exercisetheserights,includinghowtheindividualmaycomplaintothepractitioner. Thepractitioner’slegaldutieswithrespecttotheinformation,includingastatement thatthepractitionerisrequiredbylawtomaintaintheprivacyofprotectedhealth information. Whomindividualscancontactforfurtherinformationaboutthepractitioner’sprivacy policies. Thenoticemustincludeaneffectivedate.See45CFR164.520(b)forthespecific requirementsfordevelopingthecontentofthenotice. http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html SomesampleNOPPsmaybefoundatthefollowingsites: 220 http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/model-notices-privacypractices/index.html http://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/npp_fullpage_hc_provider.pdf http://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/npp-layered-provider-spanish.pdf Reporting of Communicable Disease and Abuse Statelawsvarywithregardtorequirementsforhealthcareproviderstoreportknownor suspectedcommunicablediseases,orchildorelderabuse.Youshouldbeawareofthelawin yourstate.Checkwithyourlocalpublichealthofficeabouttherequirementsabout requirementsregardingreportingspecificdiseasesforyourpracticelocation. 5. Informed Consent Itisgenerallyrecognizedthattherelationshipbetweenaclinicianandhisorherpatientcomes intobeingbecauseofthepatient’sneedandtrustintheskill,learning,andexperienceofthe clinician.Theclinicianmaynot,underordinarycircumstances,imposeservicesuponanother withoutthatperson’sconsent. Afulllegalexplanationofinformedconsentisbeyondthescopeofthismanual.However,in general,thecourtshaveruledthateveryadulthasarighttodeterminewhatistobedonewith hisorherownbody(referredtoas“autonomy”).Manystateshavespecificinformedconsent statutes.Generally,alldiagnosticandmedicalproceduresrequiretheconsentofthepatientor inthecaseofachildorsomeonewhohascertainmentalillnessesorcommunication limitations,hisorherlegalrepresentative. Informedconsentisauthorizationbythepatientorapersonauthorizedbylawtoconsenton thepatient’sbehalf.Thisauthorizationchangesatreatmentfromnonconsensualtoconsensual. Althoughmostconsentcasesinvolvephysicians,theprinciplesoflawconcerningthenatureof consentareequallyapplicabletoacupuncturists. Anacupuncturistmaybeheldliableformalpracticeif,inrenderingtreatmenttoapatient,he orshedoesnotmakeaproperdisclosuretothepatientoftherisksinvolvedintheprocedure. RequiredElements:therearefivebasicelementsthatmustbedisclosedtopatientsinlanguage thatalayindividualreasonablycanbeexpectedtounderstand: 1. Thediagnosis,includingthedisclosureofanyreservationstheproviderhasconcerning thediagnosis. 2. Thenatureandpurposeoftheproposedprocedureortreatment. 221 3. Theprobablerisksandconsequencesoftheproposedprocedureortreatment.This includesonlythoserisksandconsequencesofwhichtheproviderhas,orreasonably shouldhave,knowledge.Itisnotnecessarytodiscloseeverypotentialminorriskorside effect.Usually,itisappropriatetodisclosethoseriskswhichoccurmorethan1%ofthe timeforagivenprocedure. 4. Reasonabletreatmentalternatives.Thisincludesothertreatmentmodalitiesthatare consideredtobeappropriateforthesituation,eventhoughtheymaynotbethe personalpreferenceofthedisclosingprovider. 5. Prognosiswithouttreatment.Thepatientmustbeinformedofthepotential consequences,ifheorsheelectsnottohavetherecommendedprocedure. Writtenconsentprovidesmaterialproofofconsent.Avalid,writtenconsentmustincludethe followingelements: 1. Itmustbesigned. 2. Itmustshowthattheprocedurewastheoneconsentedto. 3. Itmustaddressthenatureoftheprocedure,alternatives,therisksinvolved,the probableconsequences,anddemonstratethatthepatientunderstoodtheseconcerns. 4. Thepatientmustfillinthedateonwhichtheformwassigned. Oralconsent,ifproven,isjustasbindingaswrittenconsent.However,oralconsentmaybe difficulttoproveincourt. Informedconsentisparticularlyimportantwhenusingtechniquesthatmightbeinterpretedas causingdamagetothebody;thisincludesacupunctureaswellasdirectmoxibustion,and cuppingorguasha,whichmayleavepetechiae/bruises. 6. High-Risk Patients AllpatientsshouldbetreatedthesamebyfollowingStandardPrecautions. 7. Other Important Safety Practices Preventing Trips and Falls AccordingtoOSHA:“Slips,trips,andfallsconstitutethemajorityofgeneralindustryaccidents. Theycause15%ofallaccidentaldeaths,andaresecondonlytomotorvehiclesasacauseof fatalities.TheOSHAstandardsforwalking/workingsurfacesapplytoallpermanentplacesof employment,exceptwhereonlydomestic,mining,oragriculturalworkisperformed.”(12) Slips:Slipsoccurwherethereistoolittlefrictionortractionbetweenthefootwearandthe walkingsurface.Thesearecommonlyrelatedtowetoroilysurfaces,weatherhazards,looseor 222 unanchoredrugsormats,andflooringorotherwalkingsurfacesthatdonothavesamedegree oftractioninallareas. Trips:Tripsoccurwhenyourfootcollides(strikes,hits)anobjectcausingyoutoloseyour balanceandfall.Commoncausesoftrippingincludepoorlighting,clutter,wrinkledcarpeting, uncoveredcables,andunevenwalkingsurfaces. How to Prevent Falls Due to Slips and Trips Bothslipsandtripsresultfromsomeakindofunintendedorunexpectedchangeinthecontact betweenthefeetandthegroundorwalkingsurface.Thisshowsthatgoodhousekeeping, qualityofwalkingsurfaces(flooring),selectionofproperfootwear,andappropriatepaceof walkingarecriticalforpreventingfallaccidents. Inhealthcarepracticesettings,slips,trips,andfallsmayberelatedtoanyoftheabove,plusthe hazardsofwalkingwithoutshoestoandfromtreatmenttables.Considercreating housekeepingandpatientcarepoliciesthatminimizetherisksofslips,trips,andfalls. Aguidetosmallbusinessandsafetycanbefoundhere: http://www.osha.gov/Publications/smallbusiness/small-business.pdf Response to a Bodily Fluid Spill ForaspillofasignificantamountofbloodorOPIM,usethefollowingguidelines: • • • • • • • • • • • Evacuatepersonnelfromtheimmediatearea,includingpatients. Blockoffareasonounauthorizedpersonmayenterthearea. Don2setsofutilitygloves. Surroundspillwithpapertowels. Putabsorbentmaterialonthespill. Ifglassisinvolvedremovetheglasswithforcepsand/ortweezers,oruseabroomand dustpantopickupanybiohazardousspillwithglassimbeddedinit. Disposeofabsorbentmaterialinhazardwastetrash.Doublebag. Changeglovesifcontaminated. Cleanareawithdetergentandwater. DisinfectareawithanEPA-approveddisinfectantappropriateforuseonthesurface beingcleaned,followingmanufacturer’sguidelinesfortheclean-upifaspill. Washhandsafterremovinggloves. First Aid Acupuncturepractitionersshouldbepreparedtodealwithbothminorandmajorhealthissues inanytreatmentsetting.ItisstronglyrecommendedthatallpractitionersmaintainactiveCPR 223 certification.ItisrecommendedthatofficeshaveaccesstoanAEDiffinanciallypossible.In addition,practitionersshouldhavepoliciesinplaceandtrainingfordealingwith: • • • • Minorcuts Bleeding,bruising Allergicreactions Firstandseconddegreeburns ItisstronglyrecommendedthateveryAOMpracticelocationhaveasimplefirstaidkitavailable foremployeeuse.Furthermore,itisstronglyrecommendedthateverypractitionermaintaina listofemergencynumbersforfire,ambulance,andpoisoncontroldirectlynexttothephone. Mental Health Issues/Suicide Practitionersmayalsowanttoevaluateotherhealthcaresituationsforwhichtheywanttobe prepared.Thismayincludementalhealthissuesincludingsuicidalideationandsuicide declarations.Therearelegalreportingrequirementsinsomestatesregardingtheseissues.Ifa patientthreatensharmagainsthimorherself,therecanbeethicalandlegaljustificationfor disclosingthatinformationtoathirdparty(e.g.,aspouseorparent)ifthatdisclosurewillhelp preventthatharm.Whilethismayfeellikeyouareviolatingtheruleofconfidentiality,havinga planandpolicyinplacewillhelpyoudealwiththesecircumstances.Seethefollowingformore information • • • http://www.dhcs.ca.gov/services/MH/Pages/SuicidePrevention.aspx http://healthinformatics.uic.edu/resources/articles/confidentiality-privacy-and-securityof-health-information-balancing-interests/ http://www.who.int/mental_health/media/en/59.pdf 8. Summary of Recommendations – Part VII • • • • • Critical:EveryAOMofficemusthaveawrittenBloodbornePathogensExposureControl Plan. Critical:EveryAOMofficemusthaveawrittenHazardousCommunicationdocument. Critical:AllAOMofficepersonnelmustfollowStandardPrecautions.Standard Precautionsinclude:1)handhygiene,2)useofpersonalprotectiveequipment(e.g., gloves,gowns,masks),3)safeinjectionpractices,4)safehandlingofpotentially contaminatedequipmentorsurfacesinthepatientenvironment,and5)respiratory hygiene/coughetiquette. Critical:EveryAOMofficemustcomplywithfiredepartmentregulationswithrespectto fireprotectionandelectricalsafety. Critical:EveryAOMofficemustcomplywithBuildingandSafetycodes. 224 • • • • • • • • • • • • • • Critical:EveryAOMofficemustcomplywithStateandFederalstandardswithrespectto documentingsafety-relatedpoliciesandprocedures. Critical:AllAOMofficesmustcreate,maintain,updateandtrainallpersonnel(including theowner/acupuncturist)onpossibleexposurestoinfectiousagentsandotherhazards annually. Critical:AllAOMofficesmustprepare,maintain,andimplementawrittenplanto identifyandhandlebiohazardouswaste. Critical:Allbiohazardouswastemustbedisposedofbyremovalbyamedicalwaste disposalcompany.Practitionersmustnotthrowmedicalwasteintothetrashfor removal. Critical:Patientrecordsshouldbekeptofallpatientvisitsandtreatmentsperformed. Themedicalrecordshouldbeacomplete,accurate,up-to-datereportofthemedical history,condition,andtreatmentofeachpatient. Critical:Practitionersmustnot,underordinarycircumstances,imposeservicesupon anotherwithoutthatperson’sconsent. StronglyRecommended:Practitionersshouldrequirewrittenconsentbeforeinstituting anyclinicalprocedures. StronglyRecommended:EveryAOMofficeshouldhaveasimplefirstaidkitavailablefor employeeuse. StronglyRecommended:EveryAOMofficeshouldpostalistofemergencynumbersfor fire,ambulance,poisoncontrol,andotheremergencypersonnelinaprominentplace suchasdirectlynexttotheofficephone. StronglyRecommended:Acupuncturepractitionersshouldhavewrittenpoliciesinplace regardingthereleaseofpatientinformation;andasageneralruletheymaynotrelease informationregardingapatient,eitherverballyorinwriting,withoutthepatient’s consent. StronglyRecommended:AllacupuncturepractitionersshouldmaintainactiveCPR certification. Recommended:Acupuncturistsshouldfollowstandardmedicalchartingprocedures suchastheSOAPnotes. Recommended:Acupuncturepractitionersshouldrepeattherequestforconsenteither verballyorinwrittenformbeforeperformingproceduresthatleavemarksonthebody (guasha,cupping),orthatmaycauseburns(moxa,heatlamps). Recommended:AOMofficesshouldhaveaccesstoanAED. References 1.OccupationalHealthandSafetyAdministration(OSHA).Regulations(Standards29CFR); Standardsforalloccupations. 225 http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p _toc_level=1&p_keyvalue=1910.AccessedDecember2012. 2.GuidetoInfectionPreventionforOutpatientSettings:MinimumExpectationsforSafeCare. CentersforDiseaseControlandPrevention,NationalCenterforEmergingandZoonotic InfectiousDiseases(NCEZID).2011. http://www.cdc.gov/hai/settings/outpatient/outpatient-care-guidelines.html.Accessed November2012. 3.OccupationalHealthandSafetyAdministration(OSHA).NeedlestickSafetyandPrevention Act.FrequentlyAskedQuestions.http://www.osha.gov/needlesticks/needlefaq.html. AccessedApril2013 4.OccupationalHealthandSafetyAdministration(OSHA).Bloodbornepathogens.1910.1030. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id =10051.AccessedDecember2012. 5.HazardCommunication.OccupationalHealthandSafetyAdministration(OSHA). http://www.osha.gov/dsg/hazcom/index.html.AccessedDecember2012. 6.OSHAStandardsforBloodbornePathogens.HealthcareEnvironmentalResourceCenter. http://www.hercenter.org/rmw/osha-BPS.cfm.AssessedDecember2012. 7.OccupationalSafetyandHealthResourceLocator.HealthcareEnvironmentalResource Center.(StatespecificOSHAinformation)http://www.hercenter.org/osha.cfm. AccessedJanuary2013. 8.HealthcareEnvironmentalResourceCenter.RegulatedMedicalWaste–Overview. http://www.hercenter.org/rmw/rmwoverview.cfm.AccessedSeptember2013 9.SafeNeedleDisposalSolutionsbyStatehttp://www.safeneedledisposal.org/.Accessed September2013 10.OccupationalSafetyandHealthStandards.1910.1030Bloodbornepathogens. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_ id=10051 11.Guidelinesforenvironmentalinfectioncontrolinhealth-carefacilities:recommendationsof CDCandtheHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC). MMWR2003;52(No.RR-10):1–48. http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdfAccessedDecember 2012. 12.Walking/WorkingSurfaces,2007.OccupationalHealthandSafetyAdministration(OSHA). http://www.osha.gov/SLTC/walkingworkingsurfaces/index.html.AccessedJanuary2013. 226 Part VIII – Appendices Appendix A: Glossary/Abbreviations Thefollowingisalistofdefinitionsoftermsandabbreviationsthatareusedinthismanual. Acupuncture:Acupunctureistheinsertionofneedlesintotheskinwherethetherapeuticeffect isexpectedtocomeprimarilyfromtheactofinserting,manipulatingand/orretainingthe needlesinspecificlocations. AE:Adverseevent. AOM:Acupunctureandorientalmedicine. Antimicrobialagent:Anyagentthatkillsorsuppressesthegrowthofmicroorganisms. Antiseptic:Substancethatpreventsorarreststhegrowthoractionofmicroorganismsby inhibitingtheiractivityorbydestroyingthem.Thetermisusedespeciallyforpreparations appliedtopicallytolivingtissue. Aseptictechniques:Techniquesforpreventinginfectionduringinvasiveproceduressuchas surgicaloperations,dressingwounds,orsomelaboratoryprocedures.Acupunctureisnotan asepticprocedurebecauseitisnotperformedinamannerthatpreservesthesterilityofthe acupuncturist’shandsortheskinofthepatient.Acupunctureisacleanratherthansterile procedure.Nevertheless,acupunctureneedlesmustbekeptinasterileconditionforusein CNT. Asepsis:Preventionofcontactwithmicroorganisms. Bacterialcount:Methodofestimatingthenumberofbacteriaperunitsample.Thetermalso referstotheestimatednumberofbacteriaperunitsample,usuallyexpressedasthenumberof colony-formingunits. Bactericide:Agentthatkillsbacteria. BBP:Bloodbornepathogens. Bestpractices:Activities,disciplinesandmethodsthatareavailabletoidentify,implement,and monitortheavailableevidenceinhealthcare,suchasthosepracticesmeanttoenhancepatient careorlimitrisks. 227 Bleach:Householdbleach(5.25%or6.00%–6.15%sodiumhypochloritedependingon manufacturer)usuallydilutedinwaterat1:10or1:100.Approximatedilutionsare1.5cupsof bleachinagallonofwaterfora1:10dilution(~6,000ppm)and0.25cupofbleachinagallonof waterfora1:100dilution(~600ppm). Contacttime:Forsurfacedisinfection,thisperiodisframedfromthemomentthedisinfectant isappliedtothesurfaceuntilcompletedryinghasoccurred. Cleanfield:Theareathathasbeenpreparedtocontaintheequipmentnecessaryfor acupunctureinsuchawayastoprotectthesterilityoftheneedles.Byextension,thisincludes notonlythecleansurfaceonwhichequipmentwillbeplaced,butalsothepatient’sskinaround preparedacupuncturepoints,andanythingthattouchestheskin.(Note:Acleanfieldisnotthe sameasasterilefield.) Cleantechnique:Theuseoftechniques(suchasantisepsis,disinfection,sterilization, handwashing,andisolationofsharps)designedtoreducetheriskofinfectionofpatients, practitioners,andofficepersonnelbyreducingthenumberofpathogens,therebyreducingthe chancesforcontactbetweenthepathogensandthepatientsandpersonnel. Cleaning:Theremoval,usuallywithdetergentandwaterorenzymecleanerandwater,of adherentvisiblesoil,blood,proteinsubstances,microorganismsandotherdebrisfromthe surfacesandlumensofinstruments,devices,andequipmentbyamanualormechanical processthatpreparestheitemsforsafehandlingand/orfurtherdecontamination. Contamination:Theintroductionofcontaminatingviruses,bacteria,orotherorganismsintoor ontopreviouslycleanorsterileobjects,renderingthemuncleanornon-sterile. Cupping(baguanfa):Theapplicationofapartialvacuumtointentionallycreatetherapeutic petechiaeandecchymosisinthedermis. Decontamination:AccordingtoOSHA,"theuseofphysicalorchemicalmeanstoremove, inactivate,ordestroybloodbornepathogensonasurfaceoritemtothepointwheretheyare nolongercapableoftransmittinginfectiousparticlesandthesurfaceoritemisrenderedsafe forhandling,use,ordisposal."[29CFR1910.1030]Inhealth-carefacilities,thetermgenerally referstoallpathogenicorganisms. Detergent:Acleaningagentthatmakesnoantimicrobialclaimsonthelabel.Suchagents compriseahydrophiliccomponentandalipophiliccomponentandcanbedividedintofour types:anionic,cationic,amphoteric,andnon-ionicdetergents. Disinfectant:Usuallyachemicalagent(butsometimesaphysicalagent)thatdestroysdiseasecausingpathogensorotherharmfulmicroorganisms,butmightnotkillbacterialspores.It 228 referstosubstancesappliedtoinanimateobjects.EPAgroupsdisinfectantsbyproductlabel claimsof"limited,""general,"or"hospital"disinfection. Disinfection:Thermalorchemicaldestructionofpathogenicandothertypesof microorganisms.Disinfectionislesslethalthansterilizationbecauseitdestroysmostrecognized pathogenicmicroorganismsbutnotnecessarilyallmicrobialforms(e.g.,bacterialspores). Dx:Diagnosis ECP:Exposurecontrolplan Electroacupuncture(EA):Theapplicationof0.5to6mAelectricalstimulationtoacupuncture needles. Efficacy/efficacious:The(possible)effectoftheapplicationofaformulationwhentestedin laboratoryorinvivosituations. Effectiveness/effective:Theclinicalconditionsunderwhichaproducthasbeentestedforits potentialtoactasperclaims,e.g.,fieldtrials. GCP:Goodclinicalpractice. Germicide:Anagentthatdestroysmicroorganisms,especiallypathogenicorganisms. Guasha:Ahealingtechniquewherethebodysurfaceis“press-stroked”withasmooth-edged instrument. HAI:Healthcareassociatedinfections. HCP:Healthcareprovider. HCW:Healthcareworker. High-leveldisinfectant:Anagentcapableofkillingwhenusedinsufficientconcentrationunder suitableconditions.Itthereforeisexpectedtokillallothermicroorganisms. Inanimatesurface:Anonlivingsurface(e.g.,floors,walls,furniture). Infectiousmicroorganisms:Microorganismscapableofproducingdiseaseinappropriatehosts. Intermediate-leveldisinfectant:Anagentthatdestroysallvegetativebacteria,including tuberclebacilli,lipidandsomenonlipidviruses,andfungi,butnotbacterialspores. Low-leveldisinfectant:Anagentthatdestroysallvegetativebacteria(excepttuberclebacilli), lipidviruses,somenonlipidviruses,andsomefungi,butnotbacterialspores. 229 Medicaldevice:Anyinstrument,apparatus,material,orotherarticle,whetherusedaloneorin combination,includingsoftwarenecessaryforitsapplication,intendedbythemanufacturerto beusedforhumanbeingsfor: • • • • • diagnosis,prevention,monitoringtreatment,oralleviationofdisease diagnosis,monitoring,treatment,oralleviationoforcompensationforaninjuryor handicap investigation,replacement,ormodificationoftheanatomyorofaphysiologicprocess controlofconception andthatdoesnotachieveitsprimaryintendedactioninoronthehumanbodyby pharmacologic,immunologic,ormetabolicmeansbutmightbeassistedinitsfunction bysuchmeans. Microbicide:Anysubstanceormixtureofsubstancesthateffectivelykillsmicroorganisms. Microorganisms:Animalsorplantsofmicroscopicsize.Asusedinhealthcare,generallyrefers tobacteria,fungi,viruses,andbacterialspores. Moxibustion:Theheatingofanacupuncturepointutilizingmoxa(Artemesiavulagaris)in variousforms. Mycobacteria:Bacteriawithathick,waxycoatthatmakesthemmoreresistanttochemical germicidesthanothertypesofvegetativebacteria. Nosocomialinfection:Aninfectionthatisacquiredfromhealthcare-associatedfacilitiesand procedures,includinghospitalsandotherthanacute-carefacilities;andinfectionsacquired throughoutpatientcare. OPIM:Otherpotentiallyinfectiousmaterial.OPIMincludessynovialfluid,amnioticfluid, cerebrospinalfluid,pleuralfluid,semenandvaginalsecretions,peritonealfluid,pericardial fluid,saliva(indentalproceduresonly),andanyfluidsvisiblycontaminatedwithbloodorstool. OPIMincludesallbodyfluidswhereitmaybedifficulttodifferentiatebetweencontaminated andnon-contaminatedfluids. Personalprotectiveequipment(PPE):Specializedclothingorequipmentwornbyanemployee forprotectionagainstahazard.Generalworkclothes(e.g.,uniforms,pants,shirts)notintended tofunctionasprotectionagainstahazardarenotconsideredtobePPE. Partspermillion(ppm):Commonmeasurementforconcentrationsbyvolumeoftrace contaminantgasesintheair(orchemicalsinaliquid);1volumeofcontaminatedgasper1 millionvolumesofcontaminatedairor1¢in$10,000bothequal1ppm.Partspermillion= μg/mLormg/L. 230 Plumblossomneedle:Ahammer-likeobjectwithmultipleneedleprojections. Prions:Transmissiblepathogenicagentsthatcauseavarietyofneurodegenerativediseasesof humansandanimals,includingsheepandgoats,bovinespongiformencephalopathyincattle, andCreutzfeldt-Jakobdiseaseinhumans.Theyareunlikeanyotherinfectiouspathogens becausetheyarecomposedofanabnormalconformationalisoformofanormalcellular protein,theprionprotein(PrP).Prionsareextremelyresistanttoinactivationbysterilization processesanddisinfectingagents. RCT:Randomizedcontrolledtrial. Residentflora(residentmicrobiota):Microorganismsresidingunderthesuperficialcellsofthe stratumcorneumandalsofoundonthesurfaceoftheskin. SAE:Seriousadverseevent. Sanitizer:Anagentthatreducesthenumberofbacterialcontaminantstosafelevelsasjudged bypublichealthrequirements,thatiscommonlyusedwithsubstancesappliedtoinanimate objects.Accordingtotheprotocolfortheofficialsanitizertest,asanitizerisachemicalthatkills 99.999%ofthespecifictestbacteriain30secondsundertheconditionsofthetest. Shelflife:Thelengthoftimeanundilutedordilutionofaproductcanremainactiveand effective.Italsoreferstothelengthoftimeasterilizedproduct(e.g.,sterileinstrumentset)is expectedtoremainsterile. SOP:Standardoperatingprocedures. Spore:Arelativelywater-poorroundorellipticalrestingcellconsistingofcondensedcytoplasm andnucleussurroundedbyanimperviouscellwallorcoat.Sporesarerelativelyresistantto disinfectantandsterilantactivityanddryingconditions(specificallyinthegeneraBacillusand Clostridium). Standardpractice:Oftensynonymouswith“customarypractice.”Itisalegaltermthatis commonlydefinedaswhataminimallycompetenthealthcareproviderinthesamefieldwould dointhesamesituation,withthesameresources. StandardPrecautions:StandardPrecautionsareasetofbasicinfectionpreventionpractices intendedtopreventtransmissionofinfectiousdiseasesfromonepersontoanother.See http://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan2011/standard-precautions.html 231 Sterileorsterility:Thestateofbeingfreefromalllivingmicroorganisms.Inpractice,usually describedasaprobabilityfunction,e.g.,astheprobabilityofamicroorganismsurviving sterilizationbeingoneinonemillion. Sterilization:Avalidatedprocessusedtorenderaproductfreeofallformsofviable microorganisms.Inasterilizationprocess,thepresenceofmicroorganismsonanyindividual itemcanbeexpressedintermsofprobability.Althoughthisprobabilitycanbereducedtoa verylownumber,itcanneverbereducedtozero. SterilizationforAOM:Theuseofproceduresthatdestroyallmicrobiallife,includingviruses. Thisisarigid,uncompromisingterm.Thereisnosuchthingaspartialsterility.Inacupuncture, sterilizationisrequiredforallinstrumentsthatpiercetheskin:needles,plumblossomneedles, seven-starhammers,lancets,andinsertiontubes. Surfactant:Anagentthatreducesthesurfacetensionofwaterorthetensionattheinterface betweenwaterandanotherliquid;awettingagentfoundinmanysterilantsanddisinfectants. Tabletopsteamsterilizer:Acompactgravity-displacementsteamsterilizerthathasachamber volumeofnotmorethan2cubicfeetandthatgeneratesitsownsteamwhendistilledor deionizedwaterisadded. TCM:TraditionalChineseMedicine. Transientflora(transientmicrobiota):Microorganismsthatcolonizethesuperficiallayersof theskinandaremoreamenabletoremovalbyroutinehandwashing. Tuina:AChinesesystemofmassageandmanipulationusingmanualmaneuvers,including pushing,rolling,kneading,rubbing,andgrasping. Use-life:thelengthoftimeadilutedproductcanremainactiveandeffective.Thestabilityof thechemicalandthestorageconditions(e.g.,temperatureandpresenceofair,light,organic matter,ormetals)determinetheuse-lifeofantimicrobialproducts. Vegetativebacteria:bacteriathataredevoidofsporesandusuallycanbereadilyinactivatedby manytypesofgermicides. Virucide:anagentthatkillsvirusestomakethemnoninfective. 232 Appendix B: Where to Find More Information FederalCDC,stateOSHAoffices,andlocalhealthdepartmentsareavailabletogive practitionersspecifichelpregardinginfectiousdiseases,toxins,orsuspiciousinjuries.You shouldkeepyourlocalhealthdepartment’sphonenumbereasilyavailableandcontactthe departmentwithanyquestionsaboutspecificdiseasesorregulationsregardingthepracticeof healthcare. World Health Organization (WHO) – Acupuncture Related Information WHO:AdverseEventsRelatedtoAcupuncture: http://www.who.int/bulletin/volumes/88/12/10-076737/en/ GuidelinesonBasicTraininginAcupuncture: http://apps.who.int/medicinedocs/en/d/Jwhozip56e/4.html SelectedPointsforBasicTraininginAcupuncture: http://apps.who.int/medicinedocs/en/d/Jwhozip56e/3.10.html#Jwhozip56e.3.10 SkinPreparation:http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf. Healthcare Associated Infections CDCGuidelines:HealthcareAssociatedInfections http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standared-precautions.html NationalClinicians’Post-ExposureProphylaxisHotline: http://nccc.ucsf.edu/clinical-resources/pep-resources/pep-quick-guide/ CDCNationalSTDHotlinehttp://www.usa.gov/directory/federal/cdc-national-std-hotline.shtml • • Email:[email protected] Toll-free:1-800-232-4636 CDCNationalPreventionInformationNetwork:http://www.cdcnpin.org/ CDC/Specific Pathogens Hepatitis • • • • • http://www.cdc.gov/hepatitis/PDFs/disease_burden.pdf http://www.cdc.gov/hepatitis/Statistics/index.htm http://www.cdc.gov/hepatitis/resources/professionals/pdfs/abctable.pdf http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepa.pdf http://www.vaccineinformation.org/hepa/qandavax.asp 233 • • • • • • • • • http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index3.html http://www.cdc.gov/HAI/pdfs/bbp/Exp_to_Blood.pdf http://www.cdc.gov/niosh/docs/2000-108/pdfs/2000-108.pdf http://www.hepb.org/professionals/high-risk_groups.htm http://www.cdc.gov/hepatitis/HBV/PDFs/HepBGeneralFactSheet.pdf http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index1.html http://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact05.pdf http://www.cdc.gov/hepatitis/Resources/Professionals/PDFs/ABCTable.pdf http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6103a1.htm UpdatedCDCRecommendationsfortheManagementofHepatitisBVirus–InfectedHealthCareProvidersandStudents • • • • • http://www.cdc.gov/hepatitis/Statistics/2010Surveillance/Commentary.htm http://www.cdc.gov/hepatitis/C/cFAQ.htm http://www.cdc.gov/hepatitis/PDFs/disease_burden.pdf http://www.cdc.gov/hepatitis/HDV/index.htm http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-relatedto-travel/hepatitis-e.htm HIV • http://www.cdc.gov/hiv/az.htm http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/index.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm http://www.cdc.gov/HAI/organisms/hiv/Surveillance-Occupationally-Acquired-HIVAIDS.html http://aids.gov/federal-resources/national-hiv-aids-strategy/nhas.pdf • • • • • http://www.cdc.gov/tb/publications/guidelines/infectioncontrol.htm http://www.cdc.gov/tb/publications/factsheets/statistics/TBTrends.htm http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf http://www.cdc.gov/tb/publications/factsheets/statistics/TBTrends.htm http://www.cdc.gov/HAI/organisms/tb.html • • • • TB Other Diseases • • • http://www.cdc.gov/bloodsafety/bbp/diseases_organisms.html http://www.cdc.gov/features/mrsainfections/ http://www2.cdc.gov/ncidod/dbmd/abcs/calc/calc_new/intro.htm 234 • • • • http://www.cdc.gov/hai/organisms/organisms.html http://www.cdc.gov/flu/professionals/infectioncontrol/index.htm http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm http://www.cdc.gov/HAI/organisms/norovirus.html Handwashing information and details • • • • • • • • http://www.cdc.gov/handhygiene/download/hand_hygiene_core.pdf http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf http://www.jointcommission.org/assets/1/18/hh_monograph.pdf http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf http://www.cdc.gov/features/handwashing/ http://www.cdc.gov/handwashing/ http://www.cdc.gov/handhygiene/index.html Standard Precautions • http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standaredprecautions.html OSHA Documents and Training Requirements OSHA Bloodborne Pathogen Standards • • • http://www.osha.gov/SLTC/bloodbornepathogens/standards.html http://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact03.pdf http://www.osha.gov/Publications/osha3151.html Exposure Control Plan (ECP) Samples • • • http://www.osha.gov/Publications/osha3186.pdf(pdfversion) http://www.osha.gov/Publications/osha3186.html(htmlversion) http://www.osha.gov/OshDoc/Directive_pdf/CPL_2-2_69_APPD.pdf(specificsmall businessplanversion) OSHA Documents Relating to ECPs • • http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=1574&p_table=DIR ECTIVES http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id =10051 Hazardous Communication • AsampleHazardousCommunicationpolicycanbefoundhere: http://www.osha.gov/Publications/osha3186.html 235 HIPAA TofindoutifyouareaHIPAA“coveredentity”referto:http://www.cms.gov/Regulations-andGuidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/AreYouaCoveredEntity.html AsummaryoftheHIPAAprivacyrulesthatapplycanbefoundhere: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf BasicHIPAAinformation: http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html SampleNOPP:www.nahu.org/members/hipaa/7_Sample_Employer_Notice.doc 236 Appendix C: Acupuncture Points that Require Special Skill Acupuncturehastraditionallytrainedpractitionersusinganoraltradition.Onlyrelatively recentlyhavecomprehensivetextsonacupuncturepointsbeenproducedinEnglish.Research onthelimitedefficacyofacupuncturepointsforspecificconditionsortimesoflifeisnotreadily availableinEnglish.Thefollowingchartismeanttobringtogetherinformationfromsources suchastheWorldHealthOrganization,(1)ChineseAcupunctureandMoxibustion,(2)AManual ofAcupuncture,(3)andsomeoraltraditionstoidentifypointsthat,insometraditions,may requiremorepracticeorskilltoutilizesafely.Notalltextsagreeonthesamelistofsuch acupuncturepoints. Someofthefollowinglistedpointsarebasedonriskreductionratherthanidealcare considerations.Forinstance,modernacumoxapracticesintheU.S.,wherescarringmaycreate amalpracticeconcern,maycreatealongerlistofpointsrequiringspecialskillthantraditional Asianpracticesutilizingacumoxainthesameareas. Thereisnoconsistentcomprehensivelistofpointsthatmaybecontraindicatedfor acupuncture,moxaorothertechniquesduringpregnancy.Traditionally,studentshavebeen cautionedtoavoidutilizingpointsthatcanbeusedtostimulatelabor(e.g.,SP6,LI4),pointson thesacrumwhichmaystimulatenervesthatalsoinnervatetheuterus(e.g.,BL31,32,33),or pointsonthefootthatmayhaveareflexactionontheuterus(e.g.,BL67).Baseduponanimal research,someresearchershavequestionedwhetherpointsthatareoftenidentifiedasbeing contraindicatedinpregnancybytraditionaltextsororaltraditionsreallyneedtobeavoidedin modernpractice.(4-6)Practitionersareurgedtofullyunderstandtheanatomicalchangesthat takeplaceduringpregnancywhenneedlingbetweenthepubisandtheumbilicus.Theyarealso cautionedtousegoodclinicaljudgmentwhenneedlingbladderpointsonthefootduring pregnancy(excepttouseBL67forbreachpresentations);andiftheyplantousepointsthatact stronglytocausetheqitodescendduringpregnancy.Studentsareurgedtostudystandard pointfunctiontextssuchasChineseAcupunctureandMoxibustion,(2)andAManualof Acupuncture(3)tounderstandwhichpointsareconsideredtoneedspecialskillifusedduring pregnancy. Acupuncturepractitionersneedtostayabreastofinformationinthefieldaboutrisks associatedwithacupuncturepractice,aswellasresearchre-assessingthosesamereportsof risks,andmakecaredecisionsbasedonevidence-informedpracticesandclinicaljudgment. GeneralAOMProcedureContraindications:Nodirect,scarringmoxaonthefaceorinthe hairline.NouseofAOMproceduresoveractiveskinlesionsoraroundareasofacutetrauma withoutspecialtrainingorsupervision.Nodeepneedlingonthethorax;useextracautionon pointstheWHOindicateshavebeenassociatedwithpneumothorax. 237 CategoriesofPoints*: A. Duetoanatomicalconsiderations,limitneedlingofpointforcriticalcircumstanceswhen otheroptionsarenotavailable;orwhenpointfunction/useoutweighstherisks. B. Duetoanatomicalconsiderationsoraccordingtohistoricaltexts,limituseof moxibustiontechniquesforlimitedcircumstanceswhenfunction/useoutweighsthe risks. C. Direct,scarringmoxibustionshouldbeavoided;therisksofdamageoutweighthe benefits(e.g.,ontheface). D. ApplyE-Stimonlywithspecialcareorforlimitedcircumstances. E. Pointisatoroveramajorvessel;usecarewhenneedling. F. PointhasbeenassociatedwithpneumothoraxbyWHOorotherauthority;limitdepth andconsiderproperangleforneedling. *Notethatthereisawidevarietyoftypesandstylesofacupuncture.Therefore,thereisalsoa widevarianceincultureandtraditionregardinganyrisksassociatedwithspecificpointuses. Eventheprecautionsassociatedwithanatomicallocationsmaybemoreorlesscritical dependinguponthestyleofacupunctureormoxibustionbeingutilized. Point: LU2 LU3 LU9 LU10 LU11 LI15 LI19 LI20 ST1 ST2,3,4,5,6,7 ST8 ST9 ST12 ST13 ST17 SP7 SP11 HT1 HT2 SI10 SI18 A X X X X X X B X X X X X X C X X X X X X X D X X X E X X X X X X F X 238 Point: BL1 BL2,3,4,5,6,7,8,9,10 BL13 BL51 BL60,61 BL62 KI11 SJ16-23 GB1TO19 GB21 LR12 REN5 REN8 REN14 REN15 REN17,18 REN22 DU4 DU6 DU11 DU15 DU16 DU17 DU18,19,20,21,22,23,24,25 DU27,28 A X X X(*) X X X X X X X X B X X X X(**) X X C X X X X X X X D X X X X X X X X E X F X X X X X *FEMALEPATIENTS(historicalreference) **MALESUNDER21only(historicalreference) References 1.WHO,GuidelinesonBasicTrainingandSafetyinAcupuncture.WorldHealthOrganization. http://apps.who.int/medicinedocs/en/d/Jwhozip56e/4.htmlAccessedNovember2012. Published1996.AccessedDecember2012. 2.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages Press,Beijing;1987 3.Deadman,P.,Al-Khafaji,M.AManualofAcupuncture.JournalofChineseMedicine Publications;2001 239 Clean Needle Technique 7th Edition FAQ Shouldpressurebeapplied beforeandduringneedle removal? No. Becauseapplyingpressurenexttoaneedlethatisbeingremoved increasestheriskforinadvertentneedlestickinjuries,bestpractice techniqueswouldbetoapplypressuretoanacupuncturepoint onlyaftertheneedlehasbeencompletelyremovedfromthesite. Doesstrongthrusting, Unknown/untested. twisting,insertingandlifting Whileitmakessensethatthemoreaneedleismanipulatedthe causeanincreaseinbleeding morebruisingandbleedingwilltakeplace,therehavebeenno andbruising? studiestosupportthistheory. Doesthesizeorwidthof Unknown/untested. needlemakeforastrongeror Generally,practitionerexpertisehasmoretodowiththeamount lessstrongneedlesensation? ofneedlesensationthandoesthesizeorwidthofanacupuncture needle. Inmakingsurethereareno Palpatingareaslookingforforgottenneedlesmayincreasetherisk needlesleftinapatientat ofneedlestickinjuries.Usecountingandproperdocumentationto theendofatreatment,does checkformissingneedles.However,ifneedlecountsdonotmatch, palpatingthesitewherea palpationmaybenecessarybutshouldbedonewithextreme needlewasinsertedfollow caution. bestpractices? Shouldwarmwaterorwater Variable. withsugarbegivento Ifthepatientjustfeelsfaint,somewater,teaorotherliquidsmay patientswhohavefainted behelpful.Ifthepatienthasfainted,thendonotforceliquidsinto duringacupuncture? themouthuntilthepatientregainsconsciousnessandclarityof thought. HowoftendoIneedtowipe Wipedowneachtreatmentchairortablewithasolutionor downatreatmenttablewith disinfectantclothbetweeneverypatientvisitandattheendofthe appropriatedisinfecting day.Aswithhandwashing,disinfectingtreatmentsurfacesmustbe solution? donebetweeneachpatientvisittopreventcrosscontamination. Whenusingamulti-needle No. packofsterilizedneedles, Onceamultipackofneedleshasbeenopened,theneedlesareno oncethepackagingisopened longersterile.Sinceyoumustuseneedlesthataresterileatthe foronepatientvisit,canthe startofeverytreatment,unusedmulti-packneedlesmustbe unusedneedlesbeusedfor discardedinasharpscontainerattheendofeachpatientvisit. anotherpatient?WhatifIam seeingthepatientsback-toback? 240 IfIusetablepaperovera sheetorotherclothtocover thetreatmentsurface,canI changethepaperonlyfor eachpatientandchangethe sheetattheendoftheday? No. Tablepaperdoesnotcompletelycovertheareathatapatientmay touch.Alltreatmentsurfacesmustbecleanedbetweeneach patientvisit.Ifusingsheetsorotherclothcoverings,thesemustbe changedforeachandeverypatientvisit. Notethattheincidenceofmycobacteriumoutbreaksinsomecases mayhavebeenassociatedwithpracticesofreusingtowelsand sheets. Canpatientsleavetheclinic Yes. withthepress Ifproperinstructionshavebeengivenregardingthecareofthe tacks/intradermalneedles skinaroundtheintradermalneedle,thencurrentstudiessuggest stillinsertedontheskin? thattheymayberetainedafterthepatientleavesthetreatment office.Writteninstructionsforreturningtotheclinicforremoval and/orasharpscontainerandinstructionsforremovalofthe intradermalneedlesathomemustbefullyexplainedbythe practitioner. Canpractitioners’handsbe No. sterilized? Sterilizationisdefinedas“thecompletedestructionofallliving tissue.”Sincepractitionersareliving,breathingindividuals,their handscanbecleanbutnotsterile. Mustadifferentguidetube No. beusedfordifferentareason Guidetubesmustbesterileatthestartofatreatmentbutaguide thepatient’sbody? tubemaybeusedformultipleneedleinsertionsatvariousareasof thepatient’sbody. Isthebestwaytocleanskin Unclear. priortoneedleorlancet Theliteratureisclearabouttheskinbeingcleanbuttherehave insertiontouse70%alcohol? beennocomparisonstudiesofsoapandwatervs.alcoholvs.other products,suchasthosecontainingchlorhexidine. HowdoIuseanalcoholswab Unclear. tocleantheskin–one Thealcoholisbeingusedtobesuretheskinisclean.Sincethe directiononlyorbackand needlesdonotenterthevasculartree,specificdirectionalityof forth“cleaning”? swabbinghasnotbeenstudied. Whendoingwetcupping No. shouldthecupbeleftin Somebloodwillbereleasedduringthelossofsuctionnomatter placeforapproximately30 howlongthecupisretained.UseofproperPPEisneededto secondsafter“breakingthe protectthepractitionerfrombloodandOPIM. seal”soastoavoidan aerosoleffectofthedrawn blood? 241 Shouldanewalcoholswab beusedfordifferentbody regions? CanIusereusableneedlesfor treatments? Whencleaningacuporgua shadevice,doIdisinfectfirst, thencleanthecupordevice? Whencleaningacuporgua shadevice,doesitneedtobe sterilized? HowdoIdecidewhetherto usehigh-orintermediate- leveldisinfectionsolutionfor mycupsandguashatools? WhatoptionsdoIhavefor holdingtheshaftofaneedle, ifnecessary,duringneedle insertion? No. Alcoholswabscanbeusedformultiplepointsinmultiplepartsof thebodyaslongastheswabremainsmoistandisnotvisiblydirty. Newswabsareneededwhencleaningareasthatarecoveredwith make-uporotherproducts,orforareaswithhighbacteriacounts suchasthegroinoraxilla. No. ThestandardofcareforU.S.CCAOMCNTcoursegraduatesisto usesingle-usesteriledisposableneedlesonly.Reusingneedlesis notpermittedlegallyinmanystates.Thecostsavedbyautoclaving needlesisnegligiblewhencomparedtothecostofevenone patientcontractingadiseasefromneedlereuse. No. Youmustremoveallbiologicalmaterialforthedisinfectanttowork properly.Cleanthedevicewithsoapandwaterfirst,thendisinfect, thenrinsethedevice(ifitisdesiredtoremoveanyremaining disinfectant)beforeusingonthenextpatient. Acuporguashadeviceneedstobecleanedofanybiological materialandthendisinfectedusinganEPA-approveddisinfecting solutionorautoclaved. Ifthecuphasorwillbeusedforwetcupping,therewillbeabreak intheskin.Inthiscase,youmustfollowtheCDCdirectivesfor cleaning,disinfecting,storingandusingsemi-criticaldevices.PPEis alsorequired.Ifthecuporguashadevicehasorwillbeusedon intactskin,youmustfollowCDCdirectivesforcleaning, disinfecting,storingandusingnoncriticaldevices.TheCNTManual adviseswhenthesetoolsareusedoverintactskin,youmustuseat leastintermediate-leveldisinfectants.Becauseyoucannotalways anticipatethattheskinwillremainintactduringcuppingorgua sha,takingtheextraprecautiontoconsiderallcupsandguasha toolsassemicriticaldevicesthatrequirehigh-leveldisinfectantsor autoclavingisstronglyrecommended. Itiseasiesttouseonemethodforallcupsandguashatools.Ifyou everusewetcupping,cuppingorguashaoverareaswherethe skinisnotintact,thebestpracticeistouseahigh-leveldisinfecting solution(aftercleaningwithsoapandwater)followingpackage directionsforsemi-criticalreusablemedical equipment.Otherwise,youhavetosegregateyourequipment betweenthoseusedonintactskinandthoseusedovernon-intact skin,whichisanunnecessarycomplication. Theshaftoftheneedlecanbetouchedwithsterilegauze,sterile cottonorasterileglove.Anythingthattouchestheshaftofthe needlebeforeinsertionintotheskinmustbesterile. 242 Whenremovingneedles,doI Unclear. needtoremoveacupuncture Whileitmakessenseforoptimalsafetypurposestoremove needlesoneatatime? needlesoneatatime,nostudieshavebeendonetodetermineif removingacoupleneedleslocatedclosetogetherisriskierthan singleneedleremoval.Whatiscriticalisthatusedneedlesbe immediatelyisolatedinanappropriatesharpscontainer. Practitionersremovingneedlesshouldneverdemonstrateor gesticulatewhileholdingusedneedlesasthisgreatlyincreasesthe riskofaneedlestickincident. Whatdoesitmean: Whenremovingneedles,usedlancetdevices,orotherusedsharps, “Immediateisolationofused theseitemsneedtobeplacedinapropersharpscontainerassoon needlesandlancets”? aspossible.Practitionersneedtodeveloppracticesthatlimitthe amountofmovementrequiredtomovethesharptothesharps container.Walkingaroundwithusedsharps,holdingthemwhile talkingtothepatientorothers,andmovingfromonelocationto anotherwithusedsharpsincreasestheriskofaneedlestickinjury. Specificallywhatfluidsare BloodandOPIM.OPIMinclude:synovialfluid,amnioticfluid, consideredpotentially cerebrospinalfluid,pleuralfluid,semenandvaginalsecretions, infectious? peritonealfluid,pericardialfluid,saliva(indentalproceduresonly), anyfluidsvisiblycontaminatedwithblood,stool,andallbodyfluids whereitmaybedifficulttodifferentiatebetweencontaminated andnon-contaminatedfluids. Whatbodilyfluidsareknown Blood,anybodyfluidcontaminatedwithblood,semen,vaginal tobeasourceforHIV secretions,synovialfluid,amnioticfluid,cerebrospinalfluid,and infections? breastmilk.SweatandurinearenotsourcesforHIVinfections. Whatarethestandard 1. Treattheexposuresiteassoonaspossibleaftertheexposure procedurestofollowafteran incident. exposureincidentsuchasa 2. Usesoapandwatertowashandcleanareasexposedtoblood needlestick? orOPIMassoonaspossibleafterexposureoccurs.DONOT “milk”apuncturesitetodrawoutsomebloodfirst. 3. Flushexposedmucusmembraneswithwater. 4. Flusheyeswithrunningwaterorsalinesolution. 5. Donotinjectantisepticsordisinfectantsintothewound. 6. Reporttheincidenttoyoursupervisor. 7. Notetheincidentintheincidentlog. 8. Utilizefollow-upproceduresasspecifiedintheclinic’sBBP manual. 243 IfIcanreachintotheclean fieldtopickupneedles,why hasitbeentaughtthatI cannotreachacrosstheclean fieldwhendisposingof uncleanitems? Whatproceduresrequire consent?Doesconsentfor acupuncturetreatmentcover cupping,bleeding,moxa,and guashaaswellasneedle insertion? Whydoesthiseditionofthe manualofferopposingviews forsometraditionally restrictedprocedures,suchas electricalstimonsomeone withapacemaker,orpoints thatrequirespecialskill? Whyarethetechniques describedinthemanual called“cleantechnique” ratherthan“sterile techniques?” Canyouuseofalcoholpump dispensersinclinicsetting ratherthanalcoholwipes? Whyistherenoreferenceto “needleretentiontime”even thoughtheCNTManual references“cupping retentiontime?” Unclear. Itisimportanttoavoidcontaminatingthecleanfieldwithdirty itemsbydroppingthemonthecleanfield,brushingclothingacross thecleanfield,ordrippinguncleanliquidsonthecleanfield. Reachingacrossthecleanfieldmaynotbeaproblemaslongas practitionersremembernottocontaminatethecleanitems.The historicalavoidanceofreachingacrossthecleanfieldhelpsremind practitionersoftheimportanceofmaintainingcleanliness. Informedconsentrequiresthatallpatientsshouldunderstandand agreetothepotentialconsequencesoftheentiretyoftheircare. Consentmustincludeanumberoffeatures,includingthenature andpurposeofaproposedtreatmentorprocedureandtherisks andbenefitsofproposedtreatmentorprocedures.Ifyour acupunctureconsentincludesthisforALLproceduresyouperform, thenthatprobablycoversyou.Butifyourconsentformonly discussesacupuncture,thenyouprobablyneedtoobtain additionalorseparateconsentforallplannedprocedures.See http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage5.html Practitionersareencouragedtoreadthemanualwithacriticaleye, reviewingtheevidenceprovidedandusingtheirpersonal knowledgeandpractitionerjudgmenttominimizerisksfortheir specificpractice.Thismanualisateachingtool.Informationabout risksandbenefitsofspecificprocedurescontinuestogrow. Practitionersareencouragedtocomparetheirstandardofcare withtheevidencefromresearchstudiesandcasestudiestocreate theirownbestpractices. Whiletheneedlesandlancetsusedasdescribedinthismanualare sterilebeforeuse,otherdevicesarecleanbutnotsterileandthe entirefieldbeingpreparedforpatienttreatmentsisclean,not sterile.Cleantechniqueisabetterdesignationthansterile techniquewhichwouldrequiresurgical-levelcleanlinessand sterility. Alcoholpumpdispenserscanthemselvesbesourceof contamination.Ifsuchdispensersused,theyshouldbedisinfected dailywithappropriateEPAapproveddisinfectingsolution. Noavailableresearchonneedleretentiontimesuggestsany adverseeffectsoflongerretention.Thisisnotthesameissueas cuppingascuppingcompressestheskinandhasprovenadverse effectsfromexcessiveretention. 244 TheManualpermitsremoval ofmultipleneedlesatsame time,butnotclearifneedles canbeplacedinintermediate containerforcounting purposesbeforebeingputin sharpscontainer. Ifapractitionerwishestotakeoutneedlesneareachotherbefore those2or3needlesareputinthesharpscontainer,andcan removethemwithoutthesharpendofanyneedlecomingbackin contactwiththepatient’sskin,thenthatispermissible.But needlescannotbeputinasecondarycontainer/receptacle betweenremovalfromabodyanddisposalinthesharpscontainer. Allneedlesneedtogoimmediatelyintoasharpscontainerafter removal. Whyisthereinconsistencyin Sweatandtearsarenotsourcesofbloodbornepathogens.Sweat theManualastowhether cancarryskinbacteriasocanbeasourceofcontaminationand sweatandtearsaresources crossinfectionofskininfectionsbetweenpatients,orpatientsand ofinfection? practitioner.Tearsarenormallynotasourceofinfectionexcept whenapersonhasacurrentconjunctivaldisease.Sothisisabout context.Wedon’texpectthatnormalhandshakesandhugsor touchingface-to-facewillspreadbloodbornepathogens.However, peoplewithconjunctivitisorimpetigoorHSVmayspreadthose illnessthroughsweatortears. Doused/contaminatedcups Disinfected,notisolated. needtobeisolatedafteruse? Ifbleedingoccurs,inadvertentlyorasaresultofwetcupping, thosecupsneedtobehandledcarefullyasbloodandOPIMwillbe presentontheinsideofthecup.Personalprotectiveequipment,in thiscaseprimarilygloves,shouldbeusedwhenhandlingsuch contaminatedcups.Strictisolationproceduresarenotnecessary. Allsuchcupsmustbecleanedanddisinfectedasdefinedinthis text.Allsurfacesthatthecontaminatedcupscomeincontactwith mustbedisinfectedaswell. Doalllabcoatsneedtobe No. launderedbythehealthcare Iftheuseoflabcoatsisasaformofuniformratherthanforthe facility? purposesofPPE,thenitisOKforcliniciansworkingathealthcare facilitiestopurchasetheirownuniformsandlaunderthoseat home. 245 Index 70%isopropylalcohol,35,71,84,174,175,176,241 adverseevent(AE):acupuncture,3,7,9,233; bleedingtherapy,48;cupping,31,32,33,34; electroacupuncture(EA),43,44,45;guasha,52, 53;moxibustion,24,25,26;PlumBlossom needling,57;presstacksandintradermalneedles, 59;serious(SAE),3,4,10,13,31,43 aggravationofsymptoms,4,9,98 AIDS,14,17,77,143,172,176,178,193 alcoholswab,71,72,174,175,241 alcohol-basedhandsanitizer,69,78,85,86,157, 158,169,170,189 antiseptic,71,157,168,170,173,174,175,192,227 aseptictechniques,xiv,1,69,126,227 autogenous,16,132 bacteria,79,131,132,149,151,153,169,170,171, 172,176,185,191,196,227,228,229,230,231, 232,242 bacterialload,73,170 bacterialspores,228,229,230 biohazardtrash,36,37 biohazardouswaste,86,197,207,211,212,213, 214,225 bleeding,3,4,39,48,50,57,69,84,92,93,96,114, 118,119,120,123,124,127,128,181,182,183, 196,207,244,245;Internal,14 bleedingdisorders,39,53,119 blistering,24,102,107,116 blood,31,32,33,35,36,48,49,50,52,57,69,74, 76,80,84,85,87,91,92,94,115,119,120,122, 124,127,132,133,134,135,136,137,138,140, 141,144,146,153,168,170,172,176,178,180, 181,183,191,197,198,199,200,206,207,208, 211,213,241,243 bodyfluid,69,74,80,127,133,135,136,137,144, 146,168,171,172,173,176,180,181,183,197, 205,206,208,212,230,243 brokenneedle,4,18,19 bruising,3,4,24,34,39,49,125,127,224 burns,xix,24,25,26,27,28,29,30,102,103,105, 106,108,109,111,113,114,117,124,125,191, 224,225 caffeine,6 CCAOM,xv,xix,72,84,188,242 CentersforDiseaseControlandPrevention(CDC), 36,49,54,74,76,91,126,127,133,136,137, 138,144,145,146,156,158,168,172,173,174, 175,177,178,180,182,189,190,193,194,197, 204,206,213,233 chemicalgermicides,190,192,230 childorelderabuse,221 chlorhexidine,72,175,241 cleanfield,68,70,74,75,76,77,82,83,84,86,87, 88,89,90,92,94,95,96,118,120,123,125,129, 159,175,177,189,228,244 CleanNeedleTechnique(CNT),17,68,69,75,76,95, 127,138,142,151,159,177,204,206,227 cleantechnique,228,244 cleaningaccidentalspills,197 Clostridiumdifficile,157,158,191 clothing,78,92,177,197,208 communicabledisease,204,221 confidentiality,179,204,205,219,224 contamination,9,50,70,72,76,77,86,92,98,125, 126,127,151,158,172,174,176,182,183,189, 196,200,228,240 cupping,4,31,32,33,34,35,36,37,39,48,53,114, 115,117,155,176,183,194,196,199,222,225, 241,242,244,245 cutaneous,3,57 disinfectant,17,36,54,60,74,77,95,97,118,127, 152,157,158,174,189,190,191,192,195,197, 201,202,228,229,240,242 ecchymosis,31,32,39,40,52,114,124,228 electricalstimulation,43,45,46,59,229 engineeringcontrols,74,156,207,208,214 fainting,3,4,7,43,93,127,240 firedepartmentregulations,204,224 forgottenneedle,4,8 fungi,149,171,230 gloves,17,35,36,37,50,57,69,74,76,84,92,95, 96,114,118,119,120,122,123,126,127,129, 144,148,152,157,158,177,181,182,183,197, 200,205,206,208,213,224 glutaraldehyde,191 GroupAStreptococcus(GAS),153 246 guasha,52,53,54,124,125,194,195,196,201, 222,225,242,244 handwashing,69,70,74,76,78,79,91,94,97,134, 152,153,155,157,159,160,168,169,170,171, 172,173,182,189,206,208,214,228,232 HazardCommunicationStandard,204,210 healthcareassociatedinfections(HAI),131,149,169, 171,233 hepatitis,3,4,14,25,48,77,80,91,126,131,133, 135,136,139,140,141,142,148,171,172,173, 176,178,179,208,219,233;hepatitisA(HAV), 134;hepatitisB(HBV),48,80,91,126,133,135, 136,137,138,139,178,179,189,192,205,207, 208,219;hepatitisC(HCV),25,80,91,126,139, 140,141,178;hepatitisD(HDV),141;hepatitisE (HEV),142 hepatitisB(HBV),48 herpessimplexvirus(HSV),34,148,154,155 HIPAA,205 HIV,80,91,131,133,139,140,143,144,145,146, 147,148,171,172,173,176,178,179,191,192, 205,234,243 housekeeping,196,201,208,223 hygiene,134,138,176,177;hand,74,126,157,158, 168,169,170,174,182,183,206,224; respiratory,156,206,224 hypochloritesolution,190,191,192,197,198,202, 228 immunesystem,91,131,133,137,147 impetigo,153 infection,3,4,14,16,24,26,33,34,36,37,48,49, 59,60,64,67,72,73,74,76,80,88,91,102,125, 126,127,131,132,133,134,135,137,138,139, 140,141,144,145,147,148,149,152,153,154, 155,157,158,160,168,174,177,178,179,189, 197,205,211,219,227,228,230 infectiousagent,77,131,132,133,171,177,180, 190 infectiousdiseases,64,127,131,132,177,180,231 influenza,155,177,197 informedconsent,204,205,221,222 injections,126,127,129,174,181 injury:bloodvessels,16;centralnervoussystem,15; heart,13;nerveinjury,3,65;organ,13; peripheralnerves,15;tissue,15 lancet,17,31,32,35,48,49,50,68,74,76,80,95, 96,114,118,119,120,123,159,176,199,207, 213,232,243,244 materiamedica,2 medicalwaste,74,85,88,212,225 methicillin-resistantStaphylococcusaureus(MRSA), 16,79,133,152,153 moxa,xix,24,25,26,27,29,68,101,102,103,104, 105,106,107,108,109,110,111,211,222,225, 230,237,244 moxasmoke,25,27,102 Mycobacteriaotherthantuberculosis(MOT),153, 154 NCCAOM,xv,xvi,xvii needlemanipulation,6,7,15,43,95,97 needlestick,8,75,76,77,80,81,92,120,136,144, 177,181,183,240,243 NeedlestickSafetyandPreventionAct(NSPA),206 norovirus,156,157 OSHA,138,180,181,182,189,193,198,200,204, 205,206,207,210,211,212,213,214,222,235 pacemaker,44,46,47,244 paresthesia,3 patientrecords,215,225 personalprotectiveequipment(PPE),35,74,114, 118,119,126,179,180,183,200,201,206,208, 224,230 petechiae,31,32,39,40,52,54,114,124,125,222, 228 plumblossom/"seven-star",17,32,57,69,74,76, 80,122,199,231,232 pneumothorax,4,10,12,32,79,95,237,238 PPD,177 publichealthsettings,91,92 riskreduction,xv,204,205 rubefaction,24 SafetyGuidelines:AggravationofSymptoms,10; AvoidFireCuppingBurns,35;AvoidOrganand CentralNervousSystemInjury,15;Avoid Pneumothorax,12;AvoidTissueInjury,16; Bloodletting,50;BrokenNeedle,19;Cup Disinfection,38;Cupping,39;Disinfecting ReusableMedicalEquipment,194;Disinfectionof GuaShaTools,55;Earseeds,63;GuaSha,53; HandSanitation,69;HeatTherapies,28; IntradermalNeedles,60;MoxaBurnPrevention, 247 26;MoxaBurnTreatment,27;MoxaSmoke Reaction,27;NeedleCupping,40;Needle Removal,9;PlumBlossomTherapy,57;Preparing andMaintainingaCleanField,70;PressTacks,60; PreventBruising,BleedingandVascularInjury,5; PreventCuppingAdverseEvents,40;Prevent Cupping-RelatedInfections,36;PreventFainting, 7;PreventInfection,17;PreventNeedleSitePain, 6;PreventingEAAdverseEvents,45;Preventing ElectricalInjuryduringEA,46;Preventing ExcessiveMuscleContractionduringEA,45; PreventingInterferencewithaCardiacPacemaker DuringEA,46;SkinPreparation,73;StuckNeedle, 8;TuiNa,65 sharps,68,73,74,75,76,78,126,189,193,199, 200,211,212,228 sharpscontainer,73,74,80,81,84,85,86,87,88, 92,199,201,208,214 soapandwater,35,36,37,54,69,71,72,78,91, 157,158,168,169,170,172,174,175,183,195, 197 SOAPnotes,217,225 spills,84,183,196,197,198,199,201 StandardPrecautions,xvii,68,74,76,77,94,137, 142,144,145,146,148,155,156,171,173,177, 180,181,200,204,206,222,224,231,235 Staphylococcus,4,131,132,151,152,171,172,176 Staphylococcusaureus,16,34,35,152 sterilant,190,191,192,196 sterile,3,17,18,26,35,57,59,60,68,69,70,75, 76,77,78,79,81,82,83,84,87,89,90,91,94, 95,96,102,106,118,122,127,128,129,143, 159,160,171,177,190,193,227,228,231,232, 240,241,242,244 sterilization,78,193,205,232 Streptococcus,131,151,153 stuckneedle,4,7 TDPlamps,27,112 treatmentrecords,215,218,219 tuberculosis(TB),133,149,150,177,180,191,234 universalprecautions.Seestandardprecautions, Seestandardprecautions vaccination,133,134,136,137,138,141,150,156, 159,174,205,207 vaccine,80,135,137,139,141,142,148,181,208 virus,131,133,143,149,171,172,176,178,189, 191,228,229,232 workplaceviolence,204 Zip-lockbags,86 248 Clean Needle Technique Manual, 7th edition