Download 40-40 - Saskatoon Health Region

POLICIES & PROCEDURES Number: 40­40 Title: Authorization:
[ 4] SHR Infection Prevention & Control Committee
[ ] Facility Board of Directors Creutzfeldt­Jakob Disease (CJD) Source: Infection Prevention & Control Date Initiated: November 26, 2002 Date Reaffirmed: June, 2003 Date Revised: May, 2007 Scope: SHR Agencies & Affiliates Introduction Transmissible spongiform encephalopathies (TSEs), also known as prion diseases, are fatal degenerative brain diseases that occur in humans and certain animal species. Human TSEs occur in sporadic, inherited, and acquired forms. FORM CAUSE Sporadic CJD (85­90%) Unknown Includes 5 subtypes with distinct clinical & pathological features Inherited prion disease Familial CJD ( 15%) Gerstmann­Straussler­Schieinker Syndrome (GSS) Fatal Familial Insomnia (FFI) Aquired by Infection Iatrogenic* CJD(<1%)
Variant CJD (vCJD)
DISTINGUISHING FEATURES Affects mainly people over age 50. Ataxia, dementia spongiform change, rarely plaques. Short course Inherited mutation in PrP gene Often younger onset than sporadic CJD. Symptom pattern depends on type of mutation, but sometimes like sporadic. Course of illness is usually longer. Contamination through brain The age at onset depends on surgery, corneal transplant, the age at exposure and on the dura mater graft, human incubation time. Clinical and growth hormone pathological features often indistinguishable from sporadic CJD. Exposure to BSE (Bovine Spongiform Encephalopathy) Young onset and longer duration than classical CJD. Psychiatric signs at presentation. Distinctive “daisy” plaques.
*Iatrogenic CJD younger onset. Ataxia rather than dementia. Growth hormone cases show plaques. TSEs are not known to spread by contact from person to person, but iatrogenic transmission can occur during invasive medical interventions. Exposure to infectious material through the use of human cadaveric­derived pituitary hormones, dural and cornea homografts, and contaminated neurosurgical instruments has caused human TSEs.
Page 1 of 8 Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) Transmission of CJD has not been associated with environmental contamination or skin contact. Normal social and clinical contact and non­invasive clinical investigations, e.g. x­ray imaging procedures with CJD patients do not present a risk to the Health Care Worker (HCW), relatives or the community. Policy 1. Standard precautions apply to all care procedures except for invasive procedures involving high or low infectivity tissues of a high risk patient or high infectivity tissue and CSF of an at­risk patient. 2. Incineration or the CJD decontamination process must be followed without exception when instruments are exposed to high or low infectivity tissues of a high risk patient or high infectivity tissue and CSF of an at­risk patient. 3. CJD precautions should be initiated when exposure to high infectivity tissues or CSF from an at­risk patient is anticipated. (See Tables 1, 2 & 3). 4. Notify Public Health Services of patients diagnosed with any form of CJD. Purpose 1. To provide guidance for precautions to prevent or minimize exposure of both patients and health care workers to CJD. Procedure 1. Risk Assessment Using the following tables 1 & 2, assess patient and tissue risk for CJD. Use table 3 to assess infection prevention & control management based on risk assessment for CJD. Table 1: Patient Risk for CJD High Risk Patient At­Risk Patient* Diagnosed CJD* Only under conditions in which there could be exposure to their high infectivity Suspected CJD** undiagnosed unusual, tissues, including CSF:
progressive neurological disease consistent · recipients of human dura mater with TSE (e.g. ataxia, dementia, myoclonus, grafts***, corneal grafts****, and etc). human pituitary hormones.
· Members of families with familial CJD, GSS and FFI***** *The incidence of CJD in Canada does not justify classifying people who have undergone neurosurgical procedures as at risk patients. ** All forms of classic CJD (sporadic, familial and iatrogenic, GSS and FFI, excluding variant CJD). *** Recipients of dura mater grafts are frequently unaware of having received the graft. ****Corneal grafts originating in a jurisdiction that requires the graft donor to be evaluated for neurological disease is not considered a risk for CJD. *****Familial CJD, Gerstmann­Sträussler­Scheinker syndrome (GSS) and Fatal Familial Insomnia (FFI) can be determined by genetic testing or may be indicated by the occurrence of two or more cases of CJD, GSS or FFI in the family (parent, child, sibling).
Page 2 of 8 Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) Table 2: Tissue Risk for CJD High infectivity Brain, spinal cord, dura mater, pituitary, eye*(including retina, optic nerve) CSF**, lung, liver, kidney, spleen, lymph nodes, placenta Adipose tissue, skin, adrenal gland, heart muscle, intestine, peripheral nerve, prostate, skeletal muscle, testis, thyroid gland, feces, milk, nasal mucus, saliva, serous exudate, sweat, tears, urine, blood, bone marrow, semen Low infectivity No detectable infectivity *The highest levels of infectivity in the eye are associated with the optic nerve and retina and, to a much lower level, the cornea. It is expected that levels of infectivity for other parts of the eye are low or nonexistent. There is no infectivity associated with tears. **Although CSF is classified as low infectivity and is less infectious than high infectivity tissues, if was felt that instruments contaminated by CSF should be handled in the same manner as those contacting high infectivity tissues in high risk and at risk patients. Table 3: Infection Prevention & Control Management based on risk assessment for CJD Risk Assessment (see Tables 1 & 2) High risk patient ­ involving high or low infectivity tissues Prevention Management (risk identified before an invasive procedure) ·
Develop and implement CJD precautions as required for specific departments (e.g. OR, Lab, SPD).
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Provide education programs to ensure that or personnel are adequately trained.
At risk patient ·
Provide advance ­ involving high notification of admission to infectivity tissues appropriate personnel (e.g. (including CSF)
ICPs)
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Provide advance notification to various departments as required (e.g. OR, Lab, SPD).
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Consider scheduling surgery at the end of the procedure day.
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Minimize personnel involved in the procedure. Ensure only educated and trained staff are involved.
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Use disposable supplies and equipment. Keep to a minimum the number of items.
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If disposable equipment cannot be used, use old instruments that are at the end of their life cycle in set up and procedures.
Containment Management Contingency Management (risk identified during an invasive procedure) (risk identified after an invasive procedure) ·
Implement CJD precautions immediately.
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Obtain and immediately implement disposable or old instruments that are at the end of their life cycle.
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Obtain and immediately implement the use of disposable supplies and equipment for invasive procedures. Keep the number of items used to a minimum.
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Minimize personnel involved in the procedure. Ensure only educated and trained staff are involved.
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Notify appropriate departments as required (e.g. OR, Lab, SPD, Facilities Services, Admin).
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Identify all reusable equipment used on patient prior to the risk being identified.
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Implement CJD precautions immediately.
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Notify appropriate departments as required (e.g. OR, Lab, SPD, Facilities Services, Admin) in order to arrange a meeting.
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Identify reusable equipment exposed to high or low infectivity tissues from a high risk patient or involving high infectivity tissue from an at risk patient. A detailed inspection of a complex or fragile piece of a reusable device may reveal that the item can be dismantled more thoroughly than anticipated. Various parts of the device may tolerate the CJD decontamination process safely. By completing this process, far less of the device may need to be incinerated. Contact the manufacturer for assistance. A decision whether or not to inform exposed patients will be contingent upon the hospital's policy.
Page 3 of 8 Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) 2. Notification
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Attending physician provides notification when a high or at risk patient is being admitted.
Notify Infection Prevention & Control Professional on admission and prior to any surgery or procedure.
Notify Operating room and laboratory prior to any surgery or procedure on a patient where CJD may be suspected. See OR and laboratory department specific policy and procedure.
Royal University Hospital (RUH) has a special case cart for the OR set up to be used for neurological procedures that involve patients with suspected CJD.
Notify Nursing units when contact with high infectivity tissues or CSF of high­risk patient or high infectivity tissues of at­risk patients is likely (e.g. use of disposable set­ups for CNS monitoring and drainage systems).
Notify Pathology at RUH prior to an autopsy. See specific autopsy room procedure.
Write the diagnosis of CJD or query CJD on the body tag when a patient expires.
If the name of the funeral home is known, call them directly so that they can use proper precautions. 3. Accommodation
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Single room is not required for infection prevention and control purposes. 4. Standard Precautions
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Are adequate for providing care to high or at risk patients under normal clinical contacts, and for non­invasive clinical investigations. Precautions are not required for personal care items (e.g. feeding tubes, suction canisters) and eating utensils.
Disposable gowns and gloves should be worn if handling contaminated or potentially contaminated equipment or articles. Refer to #6 for disposal. 5. Linen
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Standard Precautions apply, however linen that is exposed to high infectivity tissues or CSF of a high risk patient or high infectivity tissues of an at risk patient, should be treated as waste. Refer to #6 for disposal. 6. Waste Disposal
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Waste such as gowns, gloves, specimen containers, linens, instruments, sharps and sharps containers or any articles that has been exposed to high infectivity tissues or CSF of a high risk patient or high infectivity tissues of an at risk patient is to be incinerated. The container used should be one labeled “biohazardous” and also labeled “cytotoxic” on the lid otherwise it won’t be transported to an incinerator [the same procedure as for chemotherapy waste]. Refer to Annex 1. 7. Collecting/Handling Specimens
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Health care workers should wear single­use disposable protective clothing when collecting and handling high infectivity tissues or CSF from a high­risk patient or high infectivity tissues from an at­risk patient.
Page 4 of 8 Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) ·
Single­use disposable instruments should be used when performing lumbar punctures or when managing drainage systems such as those used with external lumbar and ventricular drains, and intracranial monitoring systems.
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High infectivity tissues or CSF should be collected in a sealable container, clearly labeled as high risk for CJD and placed in an outer plastic bag.
Standard laboratory practices are adequate for collecting, handling, and processing of blood, urine, and fecal specimens. ·
8. Decontamination Risk Categories The recommended levels of decontamination are shown in table 4 for different patient and tissue risk categories (including patients at risk of TSE, and patients with vCJD). The table reflects the consensus of the consultation, and should be used in conjunction with table 2 which lists specific high and low infectivity tissues, and Annex 1 (following table 4), which describes specific decontamination options. Table 4: Decontamination Levels for Different Risk Categories Patient Category Tissue Category Decontamination Options Confirmed or suspect Cases of TSE High Infectivity Annex 1 Low Infectivity Annex 1 (but note that CSF, and peripheral organs and tissues are regarded as less infectious than the CNS tissue) Annex 1 Persons with known prior High Infectivity exposure to human pituitary derived hormones, cornea or dura Low Infectivity mater grafts Members of families with High Infectivity heritable forms of TSE All of the above categories Confirmed or suspect cases of vCJD Routine cleaning and disinfection procedures No consensus was reached. The majority felt that TSE decontamination method should be used, but a minority felt this was unwarranted Low Infectivity Routine cleaning and disinfection procedures No detectable Infectivity All tissue categories Routine cleaning and disinfection procedures Annex 1 Annex 1 Decontamination methods for Transmissible Spongiform Encephalopathies The safest and most unambiguous method for ensuring that there is no risk of residual infectivity on contaminated instruments and other materials is to discard and destroy them by incineration. In some healthcare situations, as described in the guidance, one of the following less effective methods may be preferred. Wherever possible, instruments and other materials subject to re­use should be kept moist between the time of exposure to infectious materials and subsequent decontamination and cleaning. If it can be done safely, removal of adherent particles through mechanical cleaning will enhance the decontamination process.
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Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) The following recommendations are based on the best available evidence at this time and are listed in order of more to less severe treatments. These recommendations may require revision if new data become available. 1. Incineration 1. Use for all disposable instruments, materials, and wastes. 2. Preferred method for all instruments exposed to high infectivity tissues. 2. Autoclave/chemical methods for heat­resistant instruments 1. Immerse in sodium hydroxide (NaOH)* and heat in a gravity displacement autoclave at 121ºC for 30 min; clean; rinse in water and subject to routine sterilization. 2. Immerse in NaOH or sodium hypochlorite** for 1 hr; transfer instruments to water; heat in a gravity displacement autoclave at 121ºC for 1 hr; clean and subject to routine sterilization. 3. Immerse in NaOH or sodium hypochlorite for 1 hr; remove and rinse in water, then transfer to open pan and heat in a gravity displacement (121º) or porous load (134ºC) autoclave for 1 hr; clean and subject to routine sterilization. 4. Immerse in NaOH and boil for 10 min at atmospheric pressure; clean, rinse in water and subject to routine sterilization. 5. Immerse in sodium hypochlorite (preferred) or NaOH (alternative) at ambient temperature for 1 hr; clean; rinse in water and subject to routine sterilization. 6. Autoclave at 134ºC for 18 minutes.*** * Unless otherwise noted, the recommended concentration is 1N NaOH. ** Unless otherwise noted, the recommended concentration is 20,000 ppm available chlorine. ***In worse­case scenarios (brain tissue bake­dried on to surfaces) infectivity will largely but not completely removed. 3. Chemical methods for surfaces and heat sensitive instruments 1. Flood with 2N NaOH or undiluted sodium hypochlorite; let stand for 1 hr; mop up and rinse with water. 2. Where surfaces cannot tolerate NaOH or hypochlorite, thorough cleaning will remove most infectivity by dilution and some additional benefit may be derived from the use of one or another of the partially effective methods such as chlorine dioxide, glutaraldehyde, iodophores, sodium dichloro­isocyanurate or sodium metaperiodate. 4. Autoclave/chemical methods for dry goods 1. Small dry goods that can withstand either NaOH or sodium hypochlorite should first be immersed in one or the other solution (as described above) and then heated in a porous load autoclave at ≥ 121ºC for 1 hr. 2. Bulky dry goods or dry goods of any size that cannot withstand exposure to NaOH or sodium hypochlorite should be heated in a porous load autoclave at 134ºC for 1 hr.
Page 6 of 8 Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) 5. Notes about autoclaving and chemicals Gravity displacement autoclaves: Air is displaced by steam through a port in the bottom of the chamber. Gravity displacement autoclaves are designed for general decontamination and sterilization of solutions and instruments. Porous load autoclaves: Air is exhausted by vacuum and replaced by steam. Porous load autoclaves are optimized for sterilization of clean instruments, gowns, drapes, toweling, and other dry materials required for surgery. They are not suitable for liquid sterilization. Sodium Hydroxide (NaOH, or soda lye): Be familiar with and observe safety guidelines for working with NaOH. 1N NaOH is a solution of 40g NaOH in 1 litre of water. 1N NaOH readily reacts with CO² in air to form carbonates that neutralize NaOH and diminish its disinfective properties. 10N NaOH solutions do not absorb CO², therefore, 1N NaOH working solutions should be prepared fresh for each use either from solid NaOH pellets, or by dilution of 10N NaOH stock solutions. Sodium hypochlorite (NaOCl solution or bleach): Be familiar with and observe safety guidelines for working with sodium hypochlorite. Household or industrial strength bleach is sold at different concentrations in different countries, so that a standard dilution cannot be specified. Efficacy depends upon the concentration of available chlorine and should be 20,000 ppm available chlorine. One common commercial formulation is 5.25% bleach, which contains 25,000 ppm chlorine. Therefore, undiluted commercial bleach can be safely used. If solid precursors of hypochloric acid is available, then stock solution and working solutions can be prepared fresh for each use. 6. Cautions regarding hazardous materials In all cases, hazardous materials guidelines must be consulted. 1. Personnel NaOH is caustic but relatively slow acting at room temperature, and can be removed from skin or clothing by thorough rinsing with water. Hot NaOH is aggressively caustic, and should not be handled until cool. The hazard posed by hot NaOH explains the need to limit boiling to 10 minutes, the shortest time known to be effective. Hypochlorite solutions continuously evolve chlorine and so must be kept tightly sealed and away from light. The amount of chlorine released during inactivation may be sufficient to create a potential respiratory hazard unless the process is carried out in a well­ventilated or isolated location. 2. Material In principle, NaOH does not corrode stainless steel, but in practice some formulations of stainless steel can be damaged (including some used for surgical instruments). It is advisable to test a sample or consult with the manufacturer before dedicating a large number of instruments to decontamination procedures. NaOH is known to be corrosive to glass and aluminum. Hypochlorite does not corrode glass or aluminum and has also been shown to be an effective sterilizing agent; it is, however, corrosive both to stainless steel and to autoclaves and (unlike NaOH) cannot be used as an instrument bath in the autoclave. If hypochlorite is used to clean or soak an instrument, it must be completely rinsed from the surfaces before autoclaving.
Page 7 of 8 Number: Title: 40­40 Creutzfeld­Jakob Diseases (CJD) Other decontamination methods may need testing, or consultation with the manufacturer to verify their effect on the instrument. Reminders:
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In the autopsy room a separate set of instruments is used for questionable/known CJD cases only – then soaked in NaOH, autoclaved and stored. See autopsy room procedure manual.
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If diagnosis is suspected for CJD and not yet confirmed, clean, keep moist with water, and quarantine the instruments in a leak proof puncture­resistant, sealed container labeled “biohazardous” until diagnosis is confirmed. At RUH a large yellow plastic container with padlocks on either side is available for this purpose for use by all sites and is located on ground floor in the waste disposal service room near the OR. The key for the padlocks can be obtained from the OR office.
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It is recommended that quarantined items from other sites in the region be contained to prevent leakage and carefully transported for storage to the above container at RUH.
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If items subsequently need to be incinerated, they must be placed in a container labeled “biohazardous” and a second label stating “cytotoxic” must also be placed on the lid to ensure transportation to an incinerator.
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Consult Infection Prevention & Control for further CJD decontamination processes for instruments. Also refer to written guidelines in SPD and Pathology departments. References: 1. Health Canada: Classic Creutzfeldt­Jakob Disease in Canada: An infection control guideline. CCDR 2002;28S5:1­84. 2. WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. Report of a WHO consultation, Geneva, Switzerland, 23­26 March 1999. 3. Creutzfeldt­Jakob Disease Foundation: CJD & Prion Disease. Third Printing, March 2006.
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