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Transcript
8/21/2012
Welcome
Cleaning and
Monitoring
Working together to manage risk
Today’s Speakers
Kathy Thompson, CIH
Technical Service Specialist
3M Building & Commercial
Services Division
[email protected]
Grace Thornhill, Ph.D.
Technical Service Specialist
3M
Infection Prevention Division
[email protected]
1
8/21/2012
Cleaning and Monitoring for Risk
Management
• The importance of surface cleaning and disinfection
– Breaking the environmental link in the chain of infection
• Understanding non-critical surface disinfectants
– Regulations, Guidelines and Standards for disinfection
• Why process is just as important as product
– Understanding process effects on disinfection
• Applying Risk Assessment principles to surface disinfection
– Managing the risk of infection by disinfecting surfaces
– Considering other risks such as health and safety
• Using monitoring to help manage the risk
– Improving cleaning outcomes through monitoring
• Understanding cleaning monitoring methods
– Choosing a method based on your risk
• Cleaning and Monitoring – working together
The Importance of Surface
Cleaning and Disinfection
•
•
•
The environment is a source of pathogens that can contribute
to Healthcare Associated Infection (HAI) risk
Certain microorganisms are more likely than others to be of
environmental concern for HAIs
– Some live longer in the environment
– Some are more difficult to kill with low-level disinfectants
– Some have low infectious dose or antibiotic resistance that
makes them more likely to create HAI risk
Appropriate surface disinfection is needed to reduce risk
– Both product and process are important
– Understanding both can help target disinfection resources
and understand what products and processes you need
Role of hospital surfaces in the transmission of emerging health care-associated pathogens: Norovirus, Clostiridum difficle, and Acinetobacter species.
Weber, David J., and Rutala, William Al, et. al, Am J Infect Control 2010;38:S25-33
Disease Transmission Cycle
Infectious Agent
Susceptible Host
Chain of Infection
Reservoir
Disinfection
Portal of Entry
Portal of Exit
Mode of Transmission
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8/21/2012
Chain of Infection Quiz
• What breaks the link in the chain for measles?
– Vaccination prevents you from being susceptible
– Airborne mode of transmission
• What breaks the link in the chain for tuberculosis?
– Susceptibility, control the extent of inhalation exposure
– Airborne mode of transmission
• What breaks the link in the chain for hepatitis B?
– OSHA Bloodborne Pathogens Standard
• Vaccine for workers at risk, post-exposure evaluation
• Needlestick prevention – sharps disposal
• Work-practice controls – PPE, disinfecting contaminated
surfaces
• What breaks the link in the chain for norovirus?
– Surface disinfection and other practices (hand hygiene, etc.) to
minimize cross-contamination
Factors that increase infection risk
• Increasingly susceptible people
– Older, immune-compromised population
– Patients with catheters, IVs, open wounds or incisions
• Microorganism characteristics
– Resistant to antibiotics, live long and prosper
• Increased microorganism exposure
– Many people in smaller spaces (Cruise Ships, Hospitals)
– Construction activities in healthcare facilities
• Increased medical equipment cleaning challenges
– More medical equipment in patient care area
– More variety of sensitive surfaces on that equipment
Understanding Disinfectants
• Spaulding Classification based on risk
• Regulatory framework for surface disinfectants
– EPA Registration Requirements
• Disinfectant Chemistries
– Microbial Hierarchy for Disinfectant Susceptibility
• Devices vs. formulated chemical substances
– Room Decontamination Systems
• Types of Disinfectants and Sanitizers
– Professional or Healthcare Products
– Consumer or Food-Service Products
3
8/21/2012
Spaulding's Classification: Disinfection Based on Use
Level
Definition
Procedure
Goal
Example
Critical
Devices
Objects which
Sterilization
enter sterile tissue
or vascular
system
Kill all organisms,
including spores
killed
Sterilization of
Surgical
Instruments
Semi
Critical
Objects which
touch mucous
membranes or
non-intact skin
High Level
Disinfection
Kill all vegetative
organisms, spores
not killed
High level
disinfection of
Endoscopes
Noncritical
Objects which
touch only intact
skin
Low level
Removal of
Disinfection or pathogenic
Cleaning
organisms
Patient Room
Clean
Rutala et. al. Clin. Inf. Dis. 2004;39:702-9
EPA, FIFRA and Non-Critical Surface
Disinfectants
• Sanitizers and Disinfectants (Antimicrobials) for non-critical
surfaces are regulated by the EPA under FIFRA (Federal
Insecticide, Fungicide, and Rodenticide Act)
– Office of Pesticide Programs (OPP) in the EPA regulates insecticides,
antimicrobials, etc.
– FDA regulates some products with similar chemistry for disinfection or
sterilization of critical or semi-critical devices
• Surface Disinfectants become EPA Registered when
acceptable data for them is submitted to the EPA
– Efficacy Data – threshold studies showing effectiveness
• Efficacy test methods vary and are being revised
– Toxicology Data – studies showing adequate safety
– Chemistry Data – formula, manufacturing, analytical
Disinfectants are regulated by the EPA as pesticides
under FIFRA and have an EPA Registration Number
Disinfectant claims on the product label should be consistent
with EPA-approved claims listed on the EPA label
•
Several kill times and a general kill time may be listed for different
microorganisms where test data has been obtained
•
A product may be approved as a disinfectant or a cleaner-disinfectant
if it shows efficacy in the presence of organic soil
•
All disinfectants must have an EPA
Registration Number displayed on their
label, which can be used to retrieve the
EPA information for that product
•
www.epa.gov/pesticides/PPLS/
•
EPA Registered Disinfectants are required by law to be used according
to their label
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8/21/2012
Disinfectant Chemistries
Common Disinfectants for “Non-critical” Surfaces
Germicide
Use Concentration
Quat/Alcohol Combo
RTU typically
Quaternary Ammonium
Compounds or “Quats”
Mfg. use dilution and RTU
Phenolic
Mfg. use dilution and RTU
Chlorine Bleach
500 PPM
5% or RTU
1:100 Dilution (sm. spills)
5000 PPM
Hydrogen Peroxide
Peracetic Acid
1:10 Dilution (lg. spills)
Mfg. use dilution or RTU
Devices vs. Formulated Disinfectants
Formulated Disinfectants – EPA
evaluates
Have EPA Registration Numbers
Efficacy data submitted to EPA
EPA approves label claims
Have EPA Establishment Numbers for
manufacturing locations
Devices – Buyer evaluates
Can’t have EPA Registration Numbers as the
requirements for efficacy data and EPA label
approval do not apply
Have EPA Establishment Numbers for
manufacturing locations
No EPA review of efficacy is part of the
process of getting an Establishment No.
Device manufacturer may have data
Generated by third-party?
Is data representative of field use?
Room Decontamination Systems
• Concern that conventional environmental
disinfection is inadequate is a driver
• May use airborne chemicals or UV devices
• Studies showing effectiveness should be
balanced against cost, other factors
• Risk to human health?
– Exposure to chemicals or physical hazards
– HVAC balance, room leakage & re-entrapment
– Occupational exposure limits are for workers
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8/21/2012
Types of EPA Registered Antimicrobials
• Sporicidal Disinfectants – Efficacy against Clostridium difficile spores
• Intermediate Level Disinfectants (Tuberculocidal) - Kill mycobacteria,
vegetative bacteria, most viruses, and most fungi but do not necessarily
kill bacterial spores
• Low Level Disinfectants - Kill most vegetative bacteria, some fungi, and
some viruses (must be tested against certain organisms)
– Staphylococcus aureus (gram pos), Salmonella choleraesuis (gram neg), and
Pseudomonas aeruginosa to be considered Hospital-Grade
Consumer and/or Food-Service Products
• General Disinfectants – Efficacy against Staph and Salmonella
• Limited Disinfectants – Efficacy against Staph or Salmonella
• Food-Contact Sanitizer– Sanitizing efficacy against Staph and E coli in
one minute with no potable water rinse
Microbes and Susceptibility to Disinfectants
Structure of the microorganism affects the level of disinfectant
chemistry needed
Bacterial Spores
Hard to Kill
C. difficile
Mycobacterium
Tuberculosis
Non-enveloped viruses
Sporicidal disinfectant
e.g. chlorine 5000 ppm, peracetic acid
Tuberculocidal disinfectant
e.g. phenolic , quats, hydrogen peroxide,
chlorine 1000 ppm (1:50)
Norovirus as surrogate
Feline calicivirus
Fungi
Athletes foot
Vegetative Bacteria
Easy to Kill
Pseudomonas
Staphylococcus
Hospital grade disinfectant
e.g.quats, alcohol, chlorine 100 ppm
(1:500)
Enveloped viruses
HIV/AIDS
Hepatitis B
Russell, Hugo, Ayliffe. Principles and practice of
disinfection, preservation and sterilization.
John Wiley & Sons, 2004.
Are Disinfectants Effective Against Different Strains?
•
•
•
•
•
Not every genotypic strain of S. aureus has been tested (it
would not be possible)
When antibiotic-susceptible and antibiotic-resistant bacteria
were tested, there was no demonstrated correlation between
antibiotic resistance and resistance to disinfectants
Because disinfectants destroy microorganisms by disrupting
multiple cellular processes, they are immune to the effects of
resistance seen against antibiotics, which typically target
single cellular processes
CDC recommends the use of an EPA-registered disinfectant
with a claim against S. aureus to prevent the spread of
community associated MRSA
Should claims be pathogen specific or can activity against the
test organism of any group be used as claim for all of the
group
Registration of Disinfectants Based on Relative Microbicidal Activity •Author(s): William A. Rutala , PhD, MPH and David J. Weber , MD, MPH,
Source: Infection Control and Hospital Epidemiology, Vol. 25, No. 4 (April 2004), pp. 333-341
6
8/21/2012
Six Factors that Influence Cleaning
and Disinfection
•
Number of organisms
•
Organism soil
•
Resistance of the
microorganism
•
Surface design
•
Concentration/dilution
•
Contact time
Friction, detergent and attention to details are key to effective environmental
disinfection—Process, Not Product
Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008. Rutala, W, Weber, D. Healthcare Infection Control Advisory Committee Recommendations, CDC.
Product vs. Process
• Both are important
• Product is no good if
the right process isn’t
used
• How are you making
sure all necessary
surfaces are cleaned
• How are you verifying
that you have obtained
and maintained the
right disinfectant
concentration
Verifying and Maintaining
Disinfectant Concentration
Disinfectant levels can be tested to verify the
solution contains the necessary amount of active
ingredient(s)
•
•
Check disinfectant level after dilution to verify accuracy of
system
Check disinfectant level in ready-to-use container
to verify correct concentration is maintained during
surface application
– Quat test paper, titration kits preferred for accuracy
– Bleach (Chlorine) test paper to verify dilution and freshness
Use practices to maintain disinfectant levels and
prevent contamination
– Use new cleaning cloths and mops for each patient
room
– Do not contaminate the disinfectant
– Avoid dipping dirty cleaning cloths into basins of disinfectant
– Do not rinse and wring out mop heads in the bucket of
disinfectant
7
8/21/2012
Norovirus
Norovirus (Norwalk Virus)
• Common cause of human
gastroenteritis
• Highly contagious – low infectious
dose
• Disinfectant claims are for
surrogate
– Feline Calicivirus or FCV
CDC Guideline for the Prevention and
Control of Norovirus Gastroenteritis Outbreaks in Healthcare
Settings
– Routine cleaning and disinfection of high-touch surfaces and equipment in
isolation, cohort, and high-traffic clinical areas
– Clean and disinfect shared equipment between patient uses
– Increase frequency of cleaning and disinfection during outbreaks to twice
daily at the unit level and three times a daily for high-touch surfaces
– Use bleach or disinfectant with Norovirus or surrogate claims
Contact Time on Non-Critical
Surfaces
• Use EPA-registered disinfectant per manufacturer
recommendations
• Many EPA-registered hospital disinfectants still have a
general label contact time of 10 minutes, though a few
organisms have shorter contact times specifically listed
• Multiple scientific studies have demonstrated the efficacy
of hospital disinfectants against pathogens with a contact
time of at least 1 minute
• Surveyors will expect label contact time to be followed
• Use a Risk Assessment approach to determining
disinfectant choices and process steps
(www.disinfectionandsterilization.org – APIC 2011)
Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008.
Rutala, W, Weber, D. Healthcare Infection Control Advisory Committee Recommendations, CDC.
What is Appropriate Surface Disinfection?
• Disinfectant Claims
–
–
–
–
Types and Chemistry
Microorganisms and Kill Time
Formulated vs. Devices
Critically evaluate claims
• Product vs. Process
– Can the product make up for a
poor process?
– Maintaining disinfectant
concentration
– Quality Assurance methods
• Balancing all the Factors
– Efficacy and Process
– Worker and Patient Safety
– Use a risk assessment process to
get the most infection reduction
out of your disinfection resources
with acceptable safety margins
Balancing the factors
that influence appropriate
surface disinfection to
reduce risk
8
8/21/2012
What is a Risk Assessment?
• Structured process to analyze the risk in
terms of consequences and their
probabilities
• Provides a basis for decision about the most
appropriate approach to be used
• Process depends on the application
– Worker Health Risk using Formalin in Lab = Hazard x Exposure
– Formaldehyde exposure limits based on intrinsic toxicological
hazards (0.75 ppm as 8 hour TWA, 2 ppm as 15 min STEL)
– OSHA requires evaluation (e.g. air sampling) to verify inhalation
exposure is below limits and other activities to manage health risk
– Air Sampling data is used to analyze the risk and decide if
inhalation exposure controls (e.g. ventilation) are needed
ISO/IEC 31010:2009, OSHA Formaldehyde Standard 29 CFR
1910.1048
Risk Assessments and GHS
(Globally Harmonized System)
• What is GHS?
– A system of classifying and labeling hazardous chemicals
that will now be used in the US for HazCom 2012
• The MSDS is a resource for chemical safety
information used in worker risk assessments
– Information on the (M)SDS will change with GHS
• Understanding the difference between old and new
OSHA Hazard Communication Standard requirements
and information will be useful for managing worker
and patient safety risk
– May see new hazard information
US Federal Register, March 26, 2012, US Government Printing Office, Washington, DC.
Infection Control Risk Assessment (ICRA)
• Risk Assessment is part of The Joint Commission Infection
Control Standards (IC.01.03.01)
• A comprehensive risk assessment becomes the basis for
establishing program goals (IC.01.04), implementation (IC.02)
and evaluation (IC.03)
• The Joint Commission Environment of Care Standards require
an ICRA for healthcare construction activities to minimize
infection risk
• Consider implementing Surface Disinfection Risk Assessments
as a multidisciplinary process with EVS, Infection Prevention,
including Employee Health and Safety
The Joint Commission: The Source, February, Volume
8, Issue 2, 2010
9
8/21/2012
Cleaning and Monitoring for Risk
Management
• The importance of surface cleaning and disinfection
– Breaking the environmental link in the chain of infection
• Understanding non-critical surface disinfectants
– Regulations, Guidelines and Standards for disinfection
• Why process is just as important as product
– Understanding process effects on disinfection
• Applying Risk Assessment principles to surface disinfection
– Managing the risk of infection by disinfecting surfaces
– Considering other risks such as health and safety
• Using monitoring to help manage the risk
– Improving cleaning outcomes through monitoring
• Understanding cleaning monitoring methods
– Choosing a method based on your risk
• Cleaning and Monitoring – working together
What is the greatest risk to patients?
Admission to a room previously occupied by a
patient who was colonized or infected with a
multi-drug resistant organism.
Underlying Elements that Contribute to Risk
• MDRO and their persistence in the
environment
• Suboptimal Cleaning Performance
• The environment is harder to
clean
10
8/21/2012
MDRO Survival in the Environment
MDRO
Duration of Survival
Acinetobacter
Days to 5 months
Clostridium difficile
Weeks to years
Enterococcus (VRE)
Days to 4 months
Staphylococcus aureus (MRSA)
Weeks to months
Hepatitis B virus
7 days
Norovirus
12-14 days
Kramer A et al. BMC Infect Dis 2006, 6:130
Hota B Clin Infect Dis 2004; 39:1182
Performance: How are we doing?
•
•
•
•
Are protocols being followed?
Is cleaning efficacious?
Is performance consistent?
Who cleans what?
Studies show that there is room for
improvement
Monitoring Daily Cleaning Practices
Using an ATP Bioluminescence Assay
Boyce JM et al. ICHE 2009;30:678
• Objective - To evaluate the usefulness of an adenosine
triphosphate (ATP) bioluminescence assay for assessing the
efficacy of daily hospital cleaning practices.
• Conclusions - Suboptimal cleaning practices were
documented by determining aerobic colony counts and by
use of an ATP bioluminescence assay. ATP readings
provided quantitative evidence of improved cleanliness of
high-touch surfaces after the implementation of an
intervention program.
11
8/21/2012
Rooms are harder to clean!
Increase in Complexity
•
•
•
•
•
Beds
Electronics
Mobile Equipment
Personal items
Who cleans what???
Strategy to Manage Risk
Hospital Hygiene Bundle
“Interventions that are critical and
effective for assuring a clean and
disinfected environment”
Ruth Carrico, Ph.D, RN, FSHEA, CIC
Lead Clinical Advisor AHE
Clean Spaces Healthy Patients
http://cleanspaces.site.apic.org/tools-and-resources/tools-and-resources/
Proposed Bundle Elements
•
•
•
•
•
•
•
•
•
•
Disinfectant: Selection and Proper Use
Identification of surfaces and items to be cleaned/disinfected
PPE: Selection and Use
Clean/Disinfect Surfaces and items using correct techniques
Identify and report breaches in Infection Prevention
Follow Infection Prevention Practices
Proper Hand Hygiene
Monitoring effectiveness of cleaning/provide feedback
Develop clear policies and procedures
Effective education program
Ruth Carrico, Ph.D. Clean Spaces, Healthy Patients
Nancy Havill, CIC, Hosp. of St. Raphael, CT. APIC 2012 Clean Spaces, Healthy Patients
12
8/21/2012
Environmental Monitoring Program
EVS and IP share responsibility
•
•
•
•
•
•
•
Ensure compliance to established protocols
Identify problems and assess risk
Define what “clean” means in your facility
Ensure your process is under control
Focus and drive process improvement
Assess staff competency
Confirm staff training
Monitoring means:
Check, supervise, watch, keep track of….
How do we monitor environmental cleaning?
•
•
•
•
Visual Inspection
Aerobic Colony Counts (ACC)
Fluorescent Dyes/Powders/Gel
ATP Bioluminescence
Current Standard Practice:
Visual Examination
Visual assessment is not an accurate
measure of surface cleanliness nor of
microbial contamination. It can be a
misleading measure of cleaning efficacy.
Boyce et al. Monitoring the Effectiveness of Hospital Cleaning Practices by Use of an Adenosine Triphosphate
Bioluminescence Assay Infection Control and Hospital Epidemiology. July 2009, 30: 678-684.
13
8/21/2012
Aerobic Colony Counts (ACC)
• Environmental surfaces are cultured for the
presence of aerobic bacteria.
– Swab surface and culture on nutrient media
– Dip slides or RODAC plates –nutrient agar is
pressed directly onto the environmental surface
• Results are quantitative: CFU/ area tested
• Pathogens are identified in some cases.
Fluorescent Powders/Lotions/Gels
“Enhanced” Visual Inspection
• UV fluorescent molecules are incorporated into water soluble
gels , powders or lotions and used to mark an environmental
surface.
• The surface is cleaned and then re-inspected by using a UVA
light. The removal or partial removal of the fluorescent marker
indicates if a surface has been wiped.
• Generates Qualitative Results:
• Has the surface been wiped? Yes/No
• Does not tell you if a surface is clean.
Adenosine Tri-phosphate (ATP)
Bioluminescence
• ATP is present in all living organisms – animal, plant,
microorganisms, human secretions and excretions.
• Contaminated surfaces show high levels of ATP, clean surfaces
show low ATP levels.
• The surface is swabbed and the ATP levels measured in a
luminometer
• Results are quantitative: Measured in Relative Light Units
(RLU)
• Benchmark RLU levels used to define
“clean”
14
8/21/2012
Methods for Assessing Cleaning Practices
Method
Advantages
Disadvantages
Visual inspection
•Simple
•Not reliable measure of
cleanliness
Fluorescent marker
system
•Inexpensive
•Minimal equipment
needed
•Can improve practices
•Must mark surfaces
before cleaning, and
check them after cleaning
•Does not provide
quantitative measures
Aerobic colony counts
•Relatively simple
•Detects presence of
pathogens
•More expensive
•Results not available for
48 hrs later
ATP bioluminescence
assay systems
•Provides quantitative
measure of cleanliness
•Quick results
•Can improve practices
•More expensive
•Requires special
equipment
John M. Boyce, MD, APIC 2010 , Improving Cleaning and Disinfection and How to Monitor the
Effectiveness of Surface Disinfection.
Working Together to Manage Risk
• Common goals
– Patient Safety
– Clean and Safe
Environment
• EVS policies and
procedures
• IP Bundle
• Common language
– Data from Monitoring
Program
Questions ???
15