1. The Role of Verification Testing in the Prevention of HAIs in Endoscopy Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM) Co-chair of AAMI WG 84 for Endoscope Reprocessing and Manager, Clinical Education Healthmark Industries

2. Objectives Discuss methods to verify cleaning efficacy of flexible endoscopes Outline methods used to verify patient-ready status of endoscopes after reprocessing or in storage Discuss current culture methods and recommendations from CDC, FDA, etc. Discuss other methods to reduce infection prevention risks such as proper labelling of devices, transport, AER verification, quality systems Outline current standards and recommendations regarding quality systems, auditing of endoscope reprocessing, cleaning verification testing, verification of mechanical cleaning processes

3. Risk of Endoscopy Related infection or Other Adverse Patient Reactions Spread on infections related to endoscopy: o Exogenous infections = Microorganisms spread from patient to patient by contaminated or malfunctioning scopes or equipment o Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patients o Endogenous infections = Microorganisms spread from the GI tract through the bloodstream during an endoscopy procedure to susceptible organs, or may spread to adjacent tissues that are breached as a result of the endoscopic procedure

4. Risk of Endoscopy Related infection or Other Adverse Patient Reactions Other risks related to endoscopy: o Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients. Chemical burns, colitis, anaphylaxis, death o Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

5. Processing / Reprocessing Processing (or reprocessing) is a process carried out on a device to allow its subsequent safe use, which can include cleaning, disinfection, sterilization, and related procedures

6. Risk of Infection Recent Outbreaks with Gram Negative Organisms: Recent Outbreaks with Gram Negative Organisms: o University of Cincinnati Health, Published June 2016 o Lehigh Valley hospitals, PA April 2016 o University of Colorado Hospital, Jan. 2016 o Huntington Hospital in Pasadena, Aug. 2015 o Hartford Hospital, March, 2015 o Cedars-Sinai, March, 2015 o North Carolina, February, 2015 o UCLA, January 2015 o Seattle Hospital, 2012-2014 o Lutheran General Hospital in Park Ridge IL, December 2013 o UPMC, November 2012

7. Recommendations for Verification of the Cleaning Process

8. Importance of Cleaning The removal of all soil and organic material. Cleaning must precede disinfection or sterilization. Residual organic soil refers to substances such as blood, carbohydrates, or proteins that are left on the scope after manual cleaning (Alfa, 2013). Soil that remains on the endoscope may interfere with the ability of the disinfection or sterilization process to effectively kill or inactivate microorganisms and may allow for biofilm development.

9. SGNA Reprocessing Steps 1. Precleaning; 2. Leak testing; 3. Manual cleaning; 4. Rinse after cleaning; 5. Visual inspection; (includes cleaning verification) 6. High-level disinfection (manual or automated); 7. Rinse after high level disinfection; 8. Drying (alcohol and forced air); and 9. Storage

10. Manual Cleaning The composition of soil found on endoscopes includes proteins, fats, carbohydrates, and the various chemical salts that exist in blood and other body fluids. Manual cleaning of endoscopes is necessary prior to automated/manual high-level disinfection or sterilization. This is the most important step in removing the microbial burden from an endoscope. Retained debris contributes to biofilm development (Fang et al., 2010) and interferes with the HLD capability to effectively kill and/or inactivate microorganisms (Roberts, 2013). Manual cleaning and thorough brushing of channels are required even when AER manufacturers claim that manual cleaning is unnecessary (FDA, 2009).

11. SGNA “Visibly Clean” Minimum standard for cleaning assessment of scopes. May involve the use of a magnifying glass to inspect for gross soil. Visual inspection alone is insufficient to determine cleaning adequacy in narrow and internal channels of a scope and cannot detect microorganisms or bioburden (Alfa, 2014). Rapid cleaning verification tests are available. These monitors can provide documentation on cleaning efficacy but do not reflect microbial activity. Real-time testing of endoscope should be done immediately after manual cleaning so that any improperly cleaned devices are re-cleaned prior to HLD. Facilities should consider the use of monitors to verify ongoing cleaning adequacy.

12. SGNA – Visual inspection Endoscopes and reusable accessories should be visually inspected during all stages of handling, including before, during, and after use, as well as after cleaning and before HLD. Damaged endoscopes and accessories should be removed from use for repair or disposal, as this may affect their function and interfere with adequate reprocessing (Peterson et al., 2011; FDA, 2009).

13. SGNA – Endoscope Inspection VISUAL INSPECTION Visual inspection is recommended to make sure the endoscope is visibly clean. Treat as a safety stop or “time out” to ensure the endoscope is visually clean before proceeding to the next step of HLD. Visually inspect for conditions that could affect the disinfection process (e.g., cracks, corrosion, discoloration, retained debris). Use magnification and adequate lighting to help assist in visual inspection Repeat manual cleaning step(s) if not clean.

14. Verifying Clean through Inspection  AAMI ST91 : Visual inspections and testing of the equipment Inspecting organic residues Testing for any cracks in the devices Checking integrity of fiber optic bundles  Use lighted magnification and inspect throughout process  Consider inspection with borescope ST91 and AORN recommendations

15. ST91 Visual inspection Several methods can be used to evaluate the results of the cleaning process. Careful visual inspection should be conducted to detect the presence of any residual soil. Inspection using magnification and illumination might identify residues more readily than the unaided eye. Users should inspect every device for visible organic soil and contamination in a simple functionality test. Direct visual inspection is not always possible for the inner components of medical devices that have lumens. Tools such as video borescopes of an appropriate dimension (length and diameter) may be used to visually inspect the internal channels of some medical devices.

16. Optical & Enhanced Inspection AORN Recommendations: Visually inspect with lighted magnification for cleanliness, integrity, and function before use, during the procedure, after the procedure, after cleaning, and before disinfection or sterilization. Inspection helps to identify residual organic material and defective items and remove from service soiled/defective items that might put patients at risk for infection or injury. An endoscope that appears clean may harbor debris that cannot be seen without magnification. Lighted magnification may increase the ability to identify residual soil or damage. Internal channels of endoscopes may be inspected using a borescope. Borescopes penetrate the lumen and allow for improved visual inspection.

17. AAMI ST91 - Cleaning Verification Verification and monitoring of the cleaning process Cleaning verification tests are performed after cleaning to verify the effectiveness of a cleaning process to remove or reduce to an acceptable level Facilities should develop a defined program of cleaning verification that includes frequency of testing, number, and types of endoscopes to be tested. Cleaning verification results are documented. The facility has established, clarified and documented a process to address cleaning verification failures. The facility has established an education, training, and competency assessment program that verifies personnel are consistently achieving the expected level of cleaning.

18. Best Practices for Cleaning Verification & Process Monitoring Cleaning verification is performed following cleaning to verify the effectiveness of a cleaning process PRIOR TO DISINFECTION Cleaning verification should include: o Visual inspection o Testing of the cleaning efficacy of mechanical equipment o Monitoring of key cleaning parameters Use of methods to detect organic residue should be considered

19. ST91 Cleaning Verification Residual organic soil and microbial contamination may be present on an accessible surface even though the device looks clean. The use of methods that are able to quantitatively or chemically detect organic residues that are not detectable using visual inspection should be considered and included in facility policies and procedures on device cleaning What to measure, organic or indirect markers? o Protein, Carbohydrate, Hemoglobin, ATP

20. Frequency of Cleaning verification Current recommendations support testing of the manual cleaning process at pre-established regular intervals: o AAMI ST91: Regular intervals, i.e. Weekly or preferably daily o AORN: Regular intervals such as with EACH reprocessing cycle or daily o SGNA: Confirm the adequacy of manual cleaning by using a rapid cleaning monitor. If the tool results are positive, this allows for the re-cleaning of the endoscope prior to disinfection. Frequency determined by facility.

21. Manual Cleaning Verification Monitors Combination test strips ATP Systems Channel Sample Carbohydrate, protein & hemoglobin Detects ATP Flush and swab methods Many systems available Protein swabs Hemoglobin swabs Swab methods Flush methods

22. Which Organic Parameters to monitor? Flexible endoscope biopsy channel: (Alfa et al 2002) -Protein; -Carbohydrate; -Hemoglobin; Realistic benchmarks depend on what can be achieved by routine cleaning and the limit of detection of the method used. Data indicate that for flexible endoscopes that have been cleaned after use on patients, the average levels of soil markers in the suction biopsy channel are as follows: protein, <6.4 μg/cm2, carbohydrate, <1.8 μg/cm2, hemoglobin, <2.2 μg/cm2, sodium ion, <1 μmole/cm2, endotoxin, <2.2 EU/cm2, bioburden, < 4 log10 CFU/cm2 and 200 RLU for ATP (Alfa 2002, Alfa 2012, Alfa 2013).

23. Monitoring of Mechanical Processes

24. What about monitoring AERs ST91 Testing cleaning efficacy QA Program should include ways to verify that the cleaning equipment used for processing of medical devices is working. Testing the equipment upon installation, during routine use (daily) and on all cycles used, after repairs, and when changing to a new type of cleaning solution allows the user to verify its continued effectiveness. The frequency of testing the efficacy of the manual cleaning step should occur on a regular basis, weekly or preferably daily.

25. AORN – monitoring AERs Mechanical processors should be tested for performance on installation; at regular, established intervals (eg, daily, weekly); after major repairs; and after changes in programmed parameters (eg, temperature, cycle time). Testing the function of mechanical processors confirms the equipment is operating correctly. Effective processing is dependent on correctly functioning equipment. Preventive maintenance should be performed by qualified individuals

26. Options for Monitoring AER cleaning ST91 and AORN: Any mechanical cleaning process should be monitored: weekly, preferably daily Review recommendations from AER and endoscope manufacturer’s Some AER’s have automated monitoring Some have visual verification steps Others have nothing

27. Surveillance Options for Reprocessed Endoscopes

28. Microbial Surveillance Options include: o Traditional culturing o Gram negative test kits AAMI - No recommendation is made in the current version because of the timing of release. o Studies have identified the nature of microbial contamination likely to be found in improperly reprocessed endoscopes and have demonstrated the value of surveillance testing AORN: Base decision on a risk assessment Not ATP or cleaning verification tests

29. Guidance on culturing CDC Interim Guidance on culturing duodenoscopes updated 4/3/15 Sites to be cultured? o Instrument channel (suction/biopsy channel) o Distal end (elevator mechanism, elevator recess) o Elevator channel (on older, unsealed) o Frequency: Every 30 days or 60 cycles http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html

30. CDC Culture Method Baseline levels of bacteria: o Fewer than 10 CFU of low concern microbes- does not require intervention o 1 CFU or greater of high concern (pathogenic) bacteria- warrants further remedial actions o Frequency: Every 30 days or 60 cycles Not all hospital labs can do this type of testing Mail back service for endoscope samples are now available

31. CDC Culture Reprocess any contaminated duodenoscopes and re- culture. The scope should not be used again until it’s demonstrated to be free of high concern organisms or has an acceptable level of low concern organism If a reprocessing breach is identified, appropriate personnel should be notified and corrective actions implemented immediately. If cultures are repeatedly positive (3 times or more), consider evaluating the culturing technique and/or getting the scope evaluated by the manufacturer.

32. Enzymes specific to Gram-negative bacteria hydrolyze the substrate in the reagent vial o This generates fluorescence, which is read by the fluorometer, which then gives a reading. ST91: Types of verification testing may include enzyme based tests o Such as the gram negative test kit Monitoring for Gram-negative organisms in reprocessed scopes

33. Quality Infection Prevention Measures for your Facility Implementation of quality practices to reduce infection risks

34. Drying and Alcohol Flush Drying is achieve by flowing air through the endoscope channels Facilitate drying with alcohol flush (70-80% ethyl or isopropyl alcohol) Follow with instrument quality forced air to ensure residual alcohol is removed Refer to endoscope IFU for psi recommendations Dry all removable parts (valves) and do not reattach Keep valves with the endoscope to ensure traceability

35. Drying Moisture remaining on the surface or in the endoscope lumens may dilute the high- level disinfectant or interfere with the sterilization process, potentially reducing its effectiveness Instrument quality compressed air o Latest research shows it takes 10 minutes of drying o AORN: Drying cabinets are preferred If not, then HEPA filtered cabinets

36. AORN Drying AORN: Clean, filtered air is required for drying lumens and small channels without introducing contaminants into the clean device. The exterior surfaces of the endoscope should be dried with a soft, lint-free cloth or sponge and all channels purged with instrument air. Instrument air: A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01: Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40° F (-40° C).

37. Proper Storage of reprocessed endoscopes Endoscope should be hung vertically with the distal tip hanging freely in a well- ventilated, clean area following endoscope manufacturer’s IFU for storage Angulation locks in the free position Sufficient space between endoscopes All removable parts should be detached, but kept together with the endoscope o (small bag or similar device) Not touching?

38. AORN (2015) Recommendations on Flexible Endoscope Storage Visually inspect endoscopes for cleanliness before placing into or removing from storage. Wear clean gloves when handling processed scopes and when transporting them to and from the storage cabinet. Scopes should be stored with all valves open and removable parts detached but stored with the endoscope. Scopes should NOT be stored in the original shipment cases.

39. SGNA Storage Store in an area that is clean, well- ventilated and dust-free in order to keep the endoscopes dry and free of microbial contamination. An endoscope that is not dry must be reprocessed before use. Endoscopes should also hang freely so that they are not damaged by physical impact. Endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturers' IFU. Use storage cabinet, hang vertically when using a normal storage cabinet. Store valves together with the scope

40. Current recommendations for length of storage “hang time” AAMI ST91 : Due to lack of consensus it is recommended to perform a risk assessment to establish maximum length of storage. AORN : Perform a risk assessment with a multi- disciplinary team to establish a policy for maximum storage time that processed flexible endoscopes are considered safe to use without reprocessing. SGNA : 7 days based on a systematic review, if scopes are effectively reprocessed and stored in a way that keeps them completely dry and free from environmental and human contamination.

41. Length of Storage of endoscopes Risk assessment should be performed to address length of storage (hang- time) o Considerations should be given to the following: Complexity of instrument, condition after processing (wet/dry, alcohol flush), transportation methods, conditions of storage environment, handling during storage, manufacturer’s recommendations for storage, professional society guidelines, current research studies, protective devices to prevent o Now in alignment with AORN recommendations to conduct a risk assessment

42. Labelling for identification AORN: Scopes should be clearly identified with a distinct visual cue as processed and ready for use. ST91: Develop protocols to ensure that users can readily identify an endoscope that has been processed and is ready for patient use.

43. Product Recalls Written policies should be in place for a recall event (HLD or sterilization failure) Policies developed in cooperation with infection prevention and risk management Establishing recall procedures helps to ensure patient safety, compliance with user facility reporting requirements to the FDA & allows for adequate follow-up actions SGNA: Health care facilities must have policies and procedures detailing the response to any suspected or identified breaches in reprocessing. The procedure should indicate how the potentially affected patients should be identified, notified, and followed.

44. Quality Control Procedures Quality control is critical within endoscope reprocessing procedures Topics covered are product identification, traceability, documentation, record-keeping, verification and monitoring of HLD and sterilization process, product recalls and quality process improvement Facilities should develop comprehensive quality assurance and safety programs Each section outlines what parameters should be documented, tested, and/or maintained

45. Audit Recommendations CDC: Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices http://emergency.cdc.gov/han/han00382.asp Audit and Feedback Healthcare facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should assess all reprocessing steps, including: o Performing prompt cleaning after use, prior to disinfection or sterilization procedures o Using disinfectants in accordance with manufacturers’ instructions (e.g., dilution, contact time, storage, shelf-life) o Monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of sterilizer cycle parameters, appropriate record keeping) o Monitoring automated endoscope reprocessor performance (e.g., print out of flow rate, time, and temperature, use of chemical indicators for monitoring high-level disinfectant concentration)

46. Audit Recommendations Audits should be conducted in all areas of the facility where reprocessing occurs. Healthcare facilities should provide feedback from audits to personnel regarding their adherence to cleaning, disinfection, and sterilization procedures.

47. References SGNA Standards of Infection Prevention in Endoscopy, 2015. Accessed 8/23/16. http://www.sgna.org/Portals/0/Standard%20of%20Infection%20Prev ention_FINAL.pdf http://www.sgna.org/Portals/0/Standard%20of%20Infection%20Prev ention_FINAL.pdf SGNA Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes, 2016. Accessed 8/23/16. http://www.sgna.org/Portals/0/Standards%20for%20reprocessing%2 0endoscopes_FINAL.pdf http://www.sgna.org/Portals/0/Standards%20for%20reprocessing%2 0endoscopes_FINAL.pdf ANSI/AAMI ST91:2015. Flexible and semi-rigid endoscope processing in health care facilities. www.aami.orgwww.aami.org AORN. GUIDELINE FOR PROCESSING FLEXIBLE ENDOSCOPES 2016, Guidelines for Perioperative Practice. February 2016. CDC HEALTH ADVISORY: Distributed via the CDC Health Alert Network. September 11, 2015, CDCHAN-00382. Accessed 9/2/16. http://emergency.cdc.gov/han/han00382.asp http://emergency.cdc.gov/han/han00382.asp And as noted on slides…

48. Summary With heightened public concern and documented cases of improper reprocessing endoscopes, it is imperative that we must reducing the risk of exposure to improperly reprocessed medical devices. This is a shared responsibility among the healthcare facilities responsible for cleaning, disinfecting or sterilizing the devices. ST91 is your go-to guide for national standards in endoscope reprocessing and highlights best practices and quality control measures for each step along the way. Available at www.aami.orgwww.aami.org

49. My contact information: Mary Ann Drosnock Cell: 586-536-5322 1-800-521-6224/Ext.6005 Mdrosnock@hmark.com www.hmark.com www.hmark.com www.healthmarkgi.com