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How do you define clean? A tale of flexible endoscope reprocessingApril 14, 2016
Grace Thornhill, Ph.D. 3M Infection Prevention
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House Keeping
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House Keeping
Continuing Education
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Disclosure
Grace Thornhill, Ph.D.
3M Infection Prevention Division
All images from Google unless labelled otherwise
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Learning Objectives
� Explain Explain Explain Explain the differences between cleaning, highthe differences between cleaning, highthe differences between cleaning, highthe differences between cleaning, high----
level disinfection and sterilization. level disinfection and sterilization. level disinfection and sterilization. level disinfection and sterilization.
� Understand Understand Understand Understand how ATP, protein, hemoglobin and how ATP, protein, hemoglobin and how ATP, protein, hemoglobin and how ATP, protein, hemoglobin and
microbial counts are used to measure cleaning microbial counts are used to measure cleaning microbial counts are used to measure cleaning microbial counts are used to measure cleaning
efficacy. efficacy. efficacy. efficacy.
� Explain Explain Explain Explain why monitoring manual cleaning efficacy why monitoring manual cleaning efficacy why monitoring manual cleaning efficacy why monitoring manual cleaning efficacy
should not be used to predict the risk of pathogen should not be used to predict the risk of pathogen should not be used to predict the risk of pathogen should not be used to predict the risk of pathogen
transmission.transmission.transmission.transmission.5
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Cleaning Verification
Microbial Surveillance
Rapid Cleanliness MonitorsATP, Protein, Hemoglobin, Carbohydrate
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CRE Outbreaks – A Wake Up Call• Tampa
• Chicago
• Pittsburgh
• Seattle
• Wisconsin
• Los Angeles (1)
• Los Angeles (2)
• Los Angeles (3)
• These events triggered a Senate Investigation into the issue
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Preventable Tragedies:Superbugs and How Ineffective Monitoring ofMedical Device Safety Fails Patients, Jan.13, 2016United States Senate Health, Education, Labor and Pensions CommitteePatty Murray, Ranking Memberhttp://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf
• Between 2012 and spring 2015, closed-channel duodenoscopeswere linked to at least 25 different incidents of antibiotic-resistant infections that sickened at least 250 patients worldwide.
• Hospitals, FDA and mfr’s all failed in their responsibilityto report, notify and act on knowledge that outbreakswere occurring.
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The Outbreaks: No consistent root cause
How did the How did the How did the How did the duodenosopesduodenosopesduodenosopesduodenosopes become contaminated?become contaminated?become contaminated?become contaminated?
• Occult defects in the flexible endoscope
• Inadequate cleaning
o Elevator Guide wire Channel, Elevator Mechanism, Suction/Biopsy Channel
• Complex design of duodenoscope
• Current Reprocessing Guidelines are not adequate
o Residual contamination found after scopes have been reprocessed, overhauled by mfr, subjected to enhanced cleaning.
• Staff training inadequate, Questions on competency
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So what do we do now?
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What can you do now? What does everyone agree on?
Focus on Manual CleaningFocus on Manual CleaningFocus on Manual CleaningFocus on Manual Cleaning
• It is a problem
• It is critical to success of HLD and Sterilization
• Lack of proper manual cleaning contributed to outbreaks
• It can be improved
• Use validated, realUse validated, realUse validated, realUse validated, real----time indicators of cleaning efficacytime indicators of cleaning efficacytime indicators of cleaning efficacytime indicators of cleaning efficacy
o Commercially available kits that test for ATP, protein, hemoglobin,
carbohydrate
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Overview of Flexible Endoscope Reprocessing
PrePrePrePre----CleaningCleaningCleaningCleaning: Occurs in procedure room. Wipe down and flush scope.
Prepare for transport to reprocessing.
Leak testingLeak testingLeak testingLeak testing: Followed by complete disassembly of scope
Manual CleaningManual CleaningManual CleaningManual Cleaning: Flushing, brushing all parts and channels of the scope,
purge with air.
Visual InspectionVisual InspectionVisual InspectionVisual Inspection: Inspect for conditions that might affect HLD
HighHighHighHigh----Level DisinfectionLevel DisinfectionLevel DisinfectionLevel Disinfection:::: Automated in AER or can be performed manually
DryingDryingDryingDrying: Air and Alcohol flush, Wipe down external surfaces
StorageStorageStorageStorage: Vertical Hang
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Poor Poor Poor Poor CleaningCleaningCleaningCleaning
Poor HLD/SterilizationPoor HLD/SterilizationPoor HLD/SterilizationPoor HLD/Sterilization
Higher Risk of Higher Risk of Higher Risk of Higher Risk of TransmissionTransmissionTransmissionTransmission
Manual Cleaning only performed correctly 45% of the time…….
Ofstead et al. Endoscope Reprocessing Methods: A Prospective Study on the Impact of Human Factors and Automation. 2010 Gasteroenterology Nursing. Vol 33, No. 4, pp. 304-311
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Improve Improve Improve Improve CleaningCleaningCleaningCleaning
Effective Effective Effective Effective HLD/SterilizationHLD/SterilizationHLD/SterilizationHLD/Sterilization
Lower Risk Lower Risk Lower Risk Lower Risk of of of of
TransmissionTransmissionTransmissionTransmission
How to How to How to How to improve improve improve improve
cleaning? cleaning? cleaning? cleaning?
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We do not understand basic definitions
CleaningCleaningCleaningCleaning
•Removal of organic soil
•Microbes and soil can still be present
•Device can still be infectious
HighHighHighHigh----LevelLevelLevelLevel
Disinfection (HLD)Disinfection (HLD)Disinfection (HLD)Disinfection (HLD)
•Microbial kill under defined conditions
•Spores are not killed
•Effectiveness dependent on meticulous cleaning
SterilizationSterilizationSterilizationSterilization
•Kills all living organisms including spores
•Effectiveness dependent on meticulous cleaning
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TissueTissueTissueTissue
CellsCellsCellsCells
Secretions Secretions Secretions Secretions
Excretions Excretions Excretions Excretions
Body FluidsBody FluidsBody FluidsBody Fluids
BiofilmBiofilmBiofilmBiofilm “SCUM”“SCUM”“SCUM”“SCUM”
MicrobesMicrobesMicrobesMicrobes
Organic soil…..just what are we cleaning?
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So what is the big discussion again?
Cleaning Verification
Microbial Surveillance
Rapid Cleanliness Monitors
ATPATPATPATP
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Most common question: Which is better?
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Microbial Surveillance
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Microbes transmitted by dirty scopes
Bacteria
Viruses
Fungi & Parasites
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Microbes are “carried” to scopes in soil
Cells/Tissues Secretions, Excretions & Body Fluids
Biofilm Contaminated Water, Filters, Tubing
Microbes
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How are microbes detected?
Microbiological Counts Microbiological Counts Microbiological Counts Microbiological Counts
oViable microbial numbers
Pathogen Pathogen Pathogen Pathogen detectiondetectiondetectiondetection
o Culture (presence/absence)
o Molecular detection
o Methods are specific for each pathogen
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CDC Interim Duodenoscope Protocol 3/12/15
• Look for pathogens and elevated levels
of non-pathogens
• Test after HLD/Storage
• Pay Special attention to
oInspection and Manual Cleaning
o Drying
http://www.cdc.gov/hai/outbreaks/index.htmlhttp://www.cdc.gov/hai/outbreaks/index.htmlhttp://www.cdc.gov/hai/outbreaks/index.htmlhttp://www.cdc.gov/hai/outbreaks/index.html
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CDC Interim Duodenoscope Protocol 3/12/15
Interpretation of ResultsInterpretation of ResultsInterpretation of ResultsInterpretation of Results
High High High High concern organismsconcern organismsconcern organismsconcern organisms (more often associated with disease)
� Gram negatives – E. coli, Klebsiella, Pseudomonas, etc
� Gram positives – S. aureus, Enterococcus
� ≥ 1 CFU of high-concern organisms warrants remedial action
Low concern organisms Low concern organisms Low concern organisms Low concern organisms (less often associated with disease, result of sample
contamination)� Coagulase-negative staphylococcus (excluding S. lugdunensis)
� Bacillus sp
� Dipheroids (e.g. Corynebacterium, Propionibacterium)
� < 10 CFU: No intervention
� > 10 CFU – compare to baseline history, repeated high levels warrants remedial action
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The purpose of microbial surveillance (CDC surveillance protocol)
Answer two questions How many bacteria are present?
Are they harmful?
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ATP Bioluminescence
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� Universal energy management molecule
� ATP stores energy in the phosphate bonds.
� Carries energy to wherever it is needed inside cells
Adenosine
Phosphates
What is Adenosine TriWhat is Adenosine TriWhat is Adenosine TriWhat is Adenosine Tri----Phosphate (ATP)?Phosphate (ATP)?Phosphate (ATP)?Phosphate (ATP)?
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Fire-fly enzyme Luciferase uses ATP to produce Light
ATP Bioluminescence Technology
Simple RelationshipSimple RelationshipSimple RelationshipSimple Relationship
Increase organic Increase organic Increase organic Increase organic contaminationcontaminationcontaminationcontamination
Increase amount Increase amount Increase amount Increase amount of ATPof ATPof ATPof ATP
Increase Increase Increase Increase amount of amount of amount of amount of light (RLU)light (RLU)light (RLU)light (RLU)
Converts ATP to a light signalConverts ATP to a light signalConverts ATP to a light signalConverts ATP to a light signal
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Where do you find ATP?
Animals
Tissues & Cells
Secretions Excretions
Body Fluids
Plants
Food-derived soil
Plant cells and tissues
Microbes
Bacteria
Yeasts/Molds
Parasites
Organic Matter
Biofilms
“Scum”
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ATP as a rapid cleanliness monitor
Universal Cleanliness Marker
• Found in all organic soils
Used to verify cleaning efficacy for over 35 years
• Food Safety, Aerospace, Superconductor
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The purpose of ATP Rapid Cleanliness Test
Provides the answer to the following question:
How much organic soil remains after cleaning?
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Let’s use this basic knowledge to clear up some misconceptions and address a few questions
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Misception:
Microbial Surveillance is the gold standard for assessing efficacy of reprocessing endoscopes.
All other cleanliness measurement systems should mimic surveillance results.
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When are these tests performed?
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CDC Interim Protocol: The Jury is Still OUT……
•“ …Not sufficient in the current form to be implemented by
healthcare facilities as best practice” FDA Panel on Gastroenterology and
Urology, May 14-15, 2015
•Sensitivity unknown CDC Interim Protocol for Duodenoscope Surveillance
•“…clinical microbiology labs should not perform routine cultures
of reprocessed duodenoscopes due to lack of data on utility of
such culturing” American Society for Microbiology statement on CDC Interim Protocol.
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Limitations of Bacterial Culture Methods (Aerobic Plate Count)
Sensitivity
• Not sensitive enough for low levels of bacteria
• Only grows 0.1-10% of bacteria present.
Biofilm
• Not appropriate to sample biofilm
• Majority of bacteria in endoscopes grow in biofilm
Specificity
• Does not detect all bacteria.
• Not testing for other microbes (anaerobic bacteria, viruses, parasites)
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Currently, bacterial surveillance results(according to the American Society for Microbiology)
• Will not substantiate efficacy of cleanliness
• Will not tell you if the scope is adequately disinfected
• Will not indicate if a scope is sterile
• Does not detect all microbes
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Misconception:
ATP is not a good cleaning verification method because it does not correlate with bacterial counts.
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Should ATP measurements correlate with bacterial counts?A common concern, a common misconception….
Correlation should not be expected as these two methods Correlation should not be expected as these two methods Correlation should not be expected as these two methods Correlation should not be expected as these two methods
measure different measure different measure different measure different things…….. A well things…….. A well things…….. A well things…….. A well documented documented documented documented factfactfactfact....
o ATP is present in all organic soil.
o ATP comes from all living sources.
o ATP does not distinguish between living and dead ATP donors.
o Bacterial counts measure one thing – the presence of living bacteria
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CDC Surveillance Protocol
• Only measures levels of live Only measures levels of live Only measures levels of live Only measures levels of live
bacteriabacteriabacteriabacteria
• Bacterial counts are zero but Bacterial counts are zero but Bacterial counts are zero but Bacterial counts are zero but
the scope could still be the scope could still be the scope could still be the scope could still be
contaminated with contaminated with contaminated with contaminated with
o bloodbloodbloodblood----borne viruses (HIV, borne viruses (HIV, borne viruses (HIV, borne viruses (HIV, HepHepHepHep) ) ) )
o anaerobic bacteria (C. diff)anaerobic bacteria (C. diff)anaerobic bacteria (C. diff)anaerobic bacteria (C. diff)
o Fungi, parasitesFungi, parasitesFungi, parasitesFungi, parasites
ATP Bioluminescence
• Measures removal of all Measures removal of all Measures removal of all Measures removal of all
organic soil including bloodorganic soil including bloodorganic soil including bloodorganic soil including blood
• Remove the soil, remove the Remove the soil, remove the Remove the soil, remove the Remove the soil, remove the
bugs…..bugs…..bugs…..bugs…..
o bloodbloodbloodblood----borne viruses (HIV, borne viruses (HIV, borne viruses (HIV, borne viruses (HIV, HepHepHepHep) ) ) )
o anaerobic bacteria (C. diff)anaerobic bacteria (C. diff)anaerobic bacteria (C. diff)anaerobic bacteria (C. diff)
o Fungi, parasitesFungi, parasitesFungi, parasitesFungi, parasites
Simple Scenario: A scope is soiled with bloodBacterial results are zero, ATP results are high
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Misconception
ATP “does not detect microbial contamination”
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Yes, ATP does detect microbial contamination.So what is the issue?
• ATP tests do not ONLY ONLY ONLY ONLY measure bacteria?
• ATP tests do not distinguish between ATP donors?
• ATP tests do not distinguish between live and dead
ATP donors?
• ATP tests do not correlate with bacterial counts?
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Misconception
ATP monitoring is not valuable unless there is data demonstrating reduced infection risk.
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“Flexible endoscope reprocessing has been shown to have a narrow margin of safety. Any slight deviation from the recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection.”
Alfa, M.J., et al. (2006). American Journal of Infection Control, 34(9), 561-570.
RISK….
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When it comes to reprocessing endoscopes,
infection risk is not determined by one test.
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Infection Risk
Manual Cleaning
High-level Disinfection
Or Sterilization
Storage and Handling
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Misconception:
ATP assays should be validated as a risk-factor for patient-to-patient transmission.
The Pass/Fail cut off should assure safety.
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The purpose of ATP Rapid Cleanliness Test
Provides the answer to the following question:
How much organic soil remains after cleaning?
ATP tests were NEVER designed to assess transmission risk
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CDC Surveillance Protocol
• Not validated
• Sensitivity unknown
• Subject to well-documented limitations
• No recommended frequency of testing
• High-rate of false negative results
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Which is better? The question revisited.
Wrong question
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Appropriate questions
• What is the test used for?
• Do I know the limitations so that I can interpret
results correctly?
• Will the test give me the answer to the question I am
asking?
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Conclusions
1. The choice between implementing ATP monitoring or microbial
surveillance is not an either/or decision.
2. ATP and other rapid cleanliness tests are not designed to assess if
the scope is safe for patient use.
3. The current CDC surveillance protocol is still a work in progress;
the utility of the data for assessing reprocessing effectiveness is
unknown.
4. It is important to ensure that the test you are using actually
answers the questions you are asking.
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Thank you! Questions?