3M Sterile U April 14 2016 v2 - 3M Academyus.3mlearning.co.uk/uploads/elearning/a1411bc0-cb07-e611-9f7e... · 3M Health Care Academy SM © 3M 2016. All Rights Reserved 3M Health Care

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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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Disclosure

Grace Thornhill, Ph.D.

3M Infection Prevention Division

All images from Google unless labelled otherwise


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



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



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.



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?



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



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



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?



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?



So what is the big discussion again?

Cleaning Verification


Rapid Cleanliness Monitors

ATPATPATPATP



Most common question: Which is better?

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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



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



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



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)?



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



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




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.



When are these tests performed?



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)



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



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.



“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



48

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



CDC Surveillance Protocol

• Not validated

• Sensitivity unknown

• Subject to well-documented limitations

• No recommended frequency of testing

• High-rate of false negative results



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?



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?

Documents

3M Sterile U April 14 2016 v2 - 3M Academyus.3mlearning.co.uk/uploads/elearning/a1411bc0-cb07-e611-9f7e... · 3M Health Care Academy SM © 3M 2016. All Rights Reserved 3M Health Care