Challenges of Endoscope Reprocessing Marcia Patrick MSN, RN ,CIC Consultant, Infection Prevention & Control marcia.patrickip@gmail.com There are 43 slides with one polling question (Slide 2)

Polling Question How many of you perform (in your facility) High-level disinfection only Sterilization only Both sterilization and high-level disinfection

Objectives Review components of flexible endoscopes Discuss the challenges surrounding effective cleaning and reprocessing of endoscopes Describe the critical steps when reprocessing endoscopes

What are the Challenges? Maintaining a standardized process for scope reprocessing to ensure consistent, correct technique Maintaining competency among staff performing these tasks, including fill-ins Ensuring proper equipment and supplies are readily available- PPE, solutions, brushes, etc. Manufacturers’ instructions available, followed; instruments, solutions, equipment Let audience suggest challenges they have, then click to start the above list.

What are the Challenges? (2) 5. Design of some scopes makes cleaning very difficult to impossible even when following manufacturers’ instructions1 6. Lack of validated methods to overcome design flaws and inadequate instructions for processing 7. Pressure to move patients through quickly 8. Administration, staff unaware of risks of shortcuts Supervision can be a challenge if supervisor not trained in reprocessing. Ask again if anyone else has challenges they’d like to share. 1Ofstead, et. al. Persistent contamination on colonoscopes, AJIC, 2015, 43:794-801.

What are the Challenges? 9. Vendor or loaner instruments 10. Supervision when supervisor not trained in processing 11. Physical plant- layout, ventilation, sink placement, AERs or not, etc. 12. Others?

Layout of Processing Area Adequate space; negative pressure ventilation Flow from dirty to clean Ideally, pass-through from decon to clean side No crossovers Clear to everyone what stage of processing the scope and accessories are in Two sinks- double one for processing, one for hand hygiene Soiled receiving, washing, rinsing, drying, placing in HLD solution and setting timer or connecting to AER. Adequate lighting! If all one room, neutral air pressure, adequate AEH; employees remove PPE used for cleaning scope, clean hands, reglove and remove scope from solution or AER; from HLD thorough rinsing (IFU); followed by blowing channels with air and alcohol to better dry the narrow lumens,

Key Facts Staff must be trained, evaluated for competency on hire and periodically, using a competency checklist for each type of scope, following manufacturers’ instructions Repeat for any changes in the process, products Proper equipment, supplies available - PPE, brushes, solutions, disinfectant, etc. Manufacturers’ Instructions for Use (IFU) followed for ALL products, the cleaning and processing procedures, etc., ALL the time Don’t forget back-up staff who will cover for vacations or other absences Disposable brushes are single use Multi-use brushes must be cleaned of all debris and soaked with the scope

Key Facts Cleaning is the first and most important step in disinfection and sterilization All items must be physically clean before they can be chemically disinfected Improper cleaning affects the outcome- there is no magic in the HLD solution that will help, if cleaning poor High level disinfectants cannot penetrate debris left on instruments and scopes, interfering with high-level disinfection.

Key Facts It is difficult to control the myriad of steps involved in high-level disinfection and sterilization- VERY complex process ALL processes must be spot-on to ensure sterilization or high-level disinfection The more places doing this, higher risk It’s all about patient safety! Again, thorough training and retraining, observation of the work, updates as needed are essential to ensure patient safety. Often, our least educated, lowest paid staff perform these functions. It’s easier to keep ONE facility on track than many facilities. Consider transporting to a central location for processing, especially the usual instruments found in clinics.

Reuse of Single Use Devices (SUDs) Manufacturers cite “single use only” on many products (e.g., scope brushes, biopsy forceps, etc.) Re-use of these can result in financial savings; however…concern with risk of infection and injury when SUDs re-used Must consider regulatory, medical, ethical, legal, and economic issues Single use means single use. Period. Talking point: This can be a very controversial issue as ASCs are always striving to determine methods of providing quality care while saving money. Make sure you are not reprocessing items which are disposable and not used. This falls under the category of “Reprocessing” which has strict federal regulations. 3rd party reprocessors are acceptable to use for reprocessing a SUD. However, the product must meet premarket requirements from the FDA and supplemental validation that states the reprocessed device is substantially equivalent to the original device. Examples include: biopsy forceps, surgical drills and saw blades, metal orthodontic braces. See references at end of session 34 11 11

Problems With ERCP Scopes Close-up of the distal end of an ERCP scope, showing all the nooks and crannies that must be thoroughly cleaned after each use. With this magnification, one can also see the roughness and seam where the end of the device attaches to the rest of the scope- looks like a good spot for debris collection.

High-Level Disinfection- Scopes (1) Long, narrow lumens Multiple lumens Multiple ports Complex instrument Difficult to clean Associated with CRE, other infections Should we be sterilizing these? How? Many facilities no longer have ETO (gas) sterilization; banned in state of CA. Flexible scopes too long for Sterrad. Thorough cleaning is the key!

Why Endoscopes are Difficult to Clean and Disinfect Narrow lumens; right-angle bends; dead legs; multiple ports; Staff may not know to brush all the channels, ports; it is recommended to keep accessories with the scope Next slide shows distal tip of a standard scope. Rutala WA, Weber DJ. Infect Control Hosp Epidemiol 2015;36:643-648

Why Endoscopes are Difficult to Clean and Disinfect ENT Ortho GU GYN Pulmonary etc.

Flexible Endoscopes Clockwise from top right: Cross-section of an endoscope Biopsy forceps must be STERILE Duodenoscope distal end with the elevator, shows nooks and crannies, difficult to clean

High-Level Disinfection - Scopes (2) Outbreaks of CRE, other MDROs related to duodenoscopes in particular Even with following manufacturer’s IFU No validated process to check these The CDC estimates that CRE contributes to the cause of death in up to 44% of infected patients ERCP scopes often used on patients with significant disease processes- cancer, obstructions and the like- that put them at higher risk of death, however, giving them CRE or another organism is not a good thing. Elevator channel difficult to clean. https://www.ecri.org/resourceenter/Pages/Superbug.aspx

High-Level Disinfection - Scopes (3) Persistent Contamination On Colonoscopes and Gastroscopes Detected By Biologic Cultures and Rapid Indicators Despite Reprocessing Performed In Accordance With Guidelines (AJIC, 2015) Viable microbes and biologic debris persisted on clinically used gastrointestinal endoscopes, suggesting current reprocessing guidelines are not sufficient to ensure successful decontamination They tested ERCP and non-ERCP scopes Biopsy ports and caps, channels contaminated Viable microbes were recovered from patient-ready endoscopes (64% post-HLD, 9% post storage) It’s not just ERCP scopes! Components sampled at each encounter: Control handles, suction and air and water valves, biopsy ports and caps, distal ends, suction biopsy channels, and AUX channels and ports. Tests were conducted to detect protein, carbohydrate, hemoglobin, ATP, and viable microbes. Visual inspection was performed on all external endoscope components and channel effluent and sampling instruments. External surfaces were individually sampled with sterile swabs. Interior channels were assessed by testing effluent samples obtained via the flush-brush-flush method with 20 mL of sterile water and a 6-mm brush.18,21 The effluent was divided into 3 sterile collection tubes for microbiologic culturing and rapid indicator testing. Most microbes recovered were of low virulence and concentration, not likely to harm patients, but does point out processing flaws that could cause harm. Although only colonoscopes and gastroscopes were examined in this study, there are many similarities in the design and reprocessing of other endoscopic instruments for which the results of this study may be applicable. Bronchoscopes, 32,33 cystoscopes,34 have also been implicated in transmission of pathogens. Ofstead, et. al, AJIC, 2015

How Do You Know if You Have a Problem? Review patients with positive blood cultures to see if they were scoped in the days prior Keep track of which scope used on each patient Ask patients to report if they get admitted Coordinate with hospital IPs; ask them to notify if they see patients from your facility Remind physicians, mid-levels to notify you if they see patients requiring blood, other cultures Patients should go home with a handout explaining the signs and symptoms to be aware of- fever, sweats, dizziness, diarrhea, rapid pulse, low BP and what to do. Talk with the mid-levels in the physician offices so they will call you if they see a “sick” patient post-procedure. Be sure the lab is sending all positive cultures to you! If cultures not collected in your facility, you’ll probably not be able to get them through the lab.

What Should I Do? Add this to your facility risk assessment Review processing competency evaluations for staff processing scopes, include relief staff Ensure mfr instructions followed; FDA info Reeducate, retrain as needed May want to do baseline evaluation cultures following CDC culturing policy Some using rapid readout markers- ATP, protein, hemoglobin, carbohydrates Since scopes are the medical device with the most infections related to it, this should be on the risk assessment of every facility using scopes. Assess the risks of poor cleaning/processing performance of staff- are they following the scope manufacturer’s instructions to the letter? Added steps recommended by FDA? Baseline evaluation cultures make sense to determine if there’s a problem or not… follow CDC policy Rutala does not recommend the ATP or other rapid readouts as it is unknown what safe levels are for any of these- what is the correlation between a particular reading and risk of disease in a patient? It may be used to monitor cleaning, but know these are not validated processes yet. More research needed.

High Level Disinfection Indicators Check and log Minimum Effective Concentration (MEC) before each use Follow mfr quality control procedures for test strips Physical indicators: time, temperature – use a thermometer and timer, document (log) Timer begins when last item placed in solution All items fully submerged, no “floaters” Soak time per label instructions Failure of physical or chemical indicators means the solution is bad, everything goes back to CS for complete reprocessing. Change solution. Soak time may need to be increased if temperature cannot be met- example, label states “12 minutes soak time at 77° F” – contact mfr. AERs can heat to desired temp.

High Level Disinfection Indicators AERs – print out showing success; check, initial, file ALL must pass to be “good” Some products have chemical indicators and spore test strips (Steris sterilizer) which should be used Follow EPA instructions for discarding HLD solution- glutaraldehyde and OPA: neutralize with glycine prior to flushing down drain Surveyors want to see evidence that proper processes being followed. Without a log noting this, or initialed “receipts” from AERs, no proof correct processes are being followed.

Scope Storage Scopes hung in closed cabinet, not touching floor or other scopes Never store in padded case Soak and store buttons and valves in cloth or mesh bag so they stay with the same scope so if there’s a problem, you have all the items used on a particular patient

Vendor-Supplied Equipment htpps://www.iahcsmm.org/images/Resources/Loaner_instruments/Sample-_Template.pdf Need written policy; vendor must: wear name badge and appropriate attire in OR bring written cleaning, disinfection, and sterilization instructions from device manufacturer deliver in time for processing meet employee criteria for medical screening and immunizations Keep log; use for Quality Assurance/Performance Improvement (QAPI) Record equipment, vendor/lender name, patient/case number, surgeon, date, time Some facilities require loaner instruments come in vendor-supplied sterilization trays for the cycle to be used to protect and inventory instruments. Suggestion: Trays are provided on time or they’re free- write into the contract with the vendor. Vendors get own physician/company to provide immunizations and TB screening, facility doesn’t do that. Provide a standardized form. QAPI: Keep track of loaner equipment, may indicate a need to purchase certain sets if used frequently. Can Google “loaner instrument policies” or go to IAHCSMM.org for sample template- on the disk. 36 AORN Guidelines for Perioperative Practice, 2015, XIV, pp. I.STRL15-16 24 24

Enhanced Scope Processing Several approaches, in priority order: ETO sterilization after cleaning and HLD Double HLD with periodic micro surveillance HLD with scope quarantine until negative culture Liquid chemical sterilant (peracetic acid), periodic culturing Other FDA-cleared, low temp sterilization after HLD; culturing HLD with periodic micro surveillance There are rapid read products to detect protein (indicates inadequate cleaning); hemoglobin (retained blood) and carbohydrate (feeds and helps organisms stick to surfaces) W Rutala, D Weber, ICHE, 2015, 36(6); 643-648

ECRI Resource Center Develop a plan! Periodically observe scope reprocessing to ensure competency, following IFUs Preclean at point of care; thorough cleaning; proper HLD procedures- check MEC, solution temp (thermometer), timer starts when last item goes into the solution All channels flushed with alcohol and air Hung in vented cabinet with HEPA-filtered, forced air channel attachments to ensure drying ECRI- 1968, Emergency Care Research Institute, morphed into a non-profit research center. Now ECRI Institute, The Discipline of Science. The Integrity of Independence. Process surveillance- monitoring cleaning and disinfection Alcohol/air flush helps dry channels. Medical air, not Sears compressor- oil. Scope cabinets with channel attachments to filtered air ensure quick and complete drying of channels. Ensure the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage. If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

ECRI Resource Center (2) Baseline culture ALL duodenoscopes culture for a broad range of bacteria including gram negative species If positive cultures are identified, do additional selective media cultures to identify if the species present represent high or low concern bacteria See the CDC Interim Duodenoscope Surveillance Protocol for more guidance details and how to respond if positive cultures are observed Any scope with an elevator feature Follow CDC culturing guidelines, talk with lab before sending, about using selective media. These are considered environmental cultures, not clinical cultures, not all labs will do them. http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html

ECRI Resource Center (3) If high concern species are identified, this indicates that the reprocessing protocol being used may be ineffective and therefore the protocol should be carefully reviewed and monitored to verify that it adheres to recommended instructions Be sure you have the most up-to-date processing instructions, many scope manufacturers have updated these; FDA, too. If using an AER, be sure that it is being used properly, preventive maintenance and user maintenance is current, proper connections are being made. Improper connections are a big risk with both the Steris 1e and the various AERs. FDA/CDC have issued guidelines for GI scopes and bronchoscopes to enhance cleaning procedures and recommends further action such as culturing at least as a baseline.

New from AAMI ST 91, Flexible and semi-rigid endoscope processing in health care facilities Published September 2015 Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories. http://my.aami.org/store/detail.aspx?id=ST91

CDC: Culturing Scopes Interim Sampling Method for the Duodenoscope– Distal End and Instrument Channel http://www.cdc.gov/hai/settings/lab/lab-duodenoscope-sampling.html

CDC: Culturing Scopes CDC: Culture scopes monthly or after every 60 procedures; some culture weekly (e.g. Friday afternoon, results available Monday am.); each scope after each cleaning Include: instrument channel and the distal end of duodenoscope i.e., elevator mechanism and elevator recess for duodenoscopes with sealed elevator wire channel; and elevator mechanism, elevator recess, and elevator channel for duodenoscopes with unsealed elevator wire channels Duodenoscopes or any scope with an elevator mechanism. http://www.cdc.gov/hai/settings/lab/lab-duodenoscope-sampling.html

CDC: Culturing Scopes So what do you do with the results? If negative, does not mean scope is safe, but more likely to be safe If positive for low amounts of skin bugs like CNS, not likely a risk to patients, may have occurred during specimen collection- review procedure (< 10 CFU per scope) If positive for gram negative species, take action! The CDC has information on how and when to culture scopes on their website, provided on the slide. http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol-FAQs.html

Organisms High-concern organisms Staph aureus Enterococcus spp. Strep viridans P. aeruginosa Klebsiella spp. Salmonella spp. Shigella spp. Other Gram negative bacilli Low concern organisms Coag Neg Staph (CNS) Micrococci Diptheroids Bacillus spp. Other Gram positive rods Should not exceed 10 CFU per scope Colony Forming Units

CDC: Positive Cultures Reprocess, reculture, hold until results final If repeatedly positive (> x 3) for any high-concern organism or > 10 CFUs/ duodenoscope of low-concern organisms, consider re-evaluating culture technique and/or sending scope to manufacturer for evaluation

Administration’s Role They control the purse-strings Risk assessment serves as a “gap analysis” – identifies areas needing attention, resources Be sure admin aware of CMS, other requirements and where gaps are Ask your surveyor to look at specific things Remember, YOUR license is on the line and stuff runs downhill! Be sure administration is aware of the risks around scopes and garner support for additional actions around scope processing. Maybe additional cleaning time, culturing, more training, etc., better oversight of cleaning process. In facilities that are not following the rules and admin has no intention of improving the situation, carefully consider if you want to continue to work there. Notify state health dept if serious violations are ongoing, but perhaps quit first!

Summary High-level disinfection is a highly complex process with many points for failure Ensure staff are competent and supervised Keep up with changing requirements, from manufacturers to regulatory agencies Keep administration informed of gaps in practice, equipment, supplies, document

Summary Add to risk assessment Develop a plan to evaluate current practices Staff compliance with mfr IFUs Scope culturing for a baseline Develop a plan on how to approach the problem It’s all about patient safety! Surveyors will be looking for compliance with manufacturer’s instructions for cleaning and disinfection, plus the input from CDC and FDA. At this point, we are on notice and can’t just do nothing. Competency evaluations of staff performing the processing is essential- they must demonstrate they know the procedure and follow it faithfully.

Objectives Review components of flexible endoscopes Discuss the challenges surrounding effective cleaning and reprocessing of endoscopes Describe the critical steps when reprocessing endoscopes So we’ve talked about the many challenges in high-level disinfection and sterilization that put patients at risk. Cleaning is critical for instruments and scopes to permit high-level disinfection or sterilization of scopes and instruments, as is following ALL the instructions for use from the various manufacturers- the device, the cleaning products, disinfectants (including soak time, temp, MEC testing) and for sterilization, the instrument, the sterilizer, the container or wrapper, and all the process monitors that are required to ensure patient safety: physical, chemical and biological. Records for all of these must be kept so the facility has a track record of proper functioning of their processes.

AAMI Standards for High Level Disinfection and Sterilization in Health Care Settings Association for the Advancement of Medical Instrumentation Sterilization Pt 1: Sterilization in Health Care Facilities, 2015 ed. - includes 14 AAMI sterilization standards and documents for health care facilities, incl. ST79 ST79: ANSI/AAMI Comprehensive Guide to Steam Sterilization & Sterility Assurance in Health Care Facilities ST58 High-Level Disinfection ST55 Desktop Sterilizers ST40-2004(R 2010) Dry Heat Sterilization ST 91 Flexible and Semi-rigid Endoscope Processing in Health Care Facilities, 2015. Can purchase ST 79 at link provided, $290 (non-member) as of 1/15. AAMI has many standards for High Level Disinfection and Sterilization in Health care Settings so check their website to see all they have. Easier to search for the references than try to see the links in the handouts! http://www.aami.org/productspublications/ProductList.aspx?metadataid=149

References AORN Guidelines for Perioperative Practice, 2015. Updated annually, usually in February Every IP with an OR needs these Guidelines! CDC Guideline for Disinfection and Sterilization, 2008, available for free at cdc.gov, or search the title

References Falagas, T, Tansarli, M, Karageorgopoulos, D, et. al. Deaths attributable to carbapenem-resistant Enterobacteriaceae infections. Emerg Infect Dis. 2014; 20(7):1170-5. C.L. Ofstead, et al. Persistent Contamination On Colonoscopes and Gastroscopes Detected By Biologic Cultures and Rapid Indicators Despite Reprocessing Performed In Accordance With Guidelines Am Journal Infect Cont 2015:43 794-801 (August 2015)

References FDA. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. 8/14/2000. Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data, April, 2003. http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10413.html 66 42 42

References FDA Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data Attachment 1. List of SUDS Known to be Reprocessed or Considered for Reprocessing http://www.fda.gov/RegulatoryInformation/Guidances/ucm107164.htm FDA. Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling Guidance for Industry and FDA Staff . March 17, 2015. http://www.fda.gov/MedicalDevices/default.htm 67

References Rutala, W, Weber, D. ERCP Scopes: What Can We Do to Prevent Infections? Inf Control Hosp Epidemiol 2015; 36(6): 643-648 Whitely, GS, et.al. The Perennial Problem of Variability in ATP Tests for Hygiene Monitoring Within Healthcare Settings, ICHE, 2015, 36(6); 658-663. Wendorf, K, et. al. ERCP-Associated AmpC E. Coli Outbreak. ICHE, 2015, 36(6), 634-642.

Resources AORN (Association of periOperative Registered Nurses) at www.aorn.org CDC HICPAC Guidelines for Healthcare Facilities at http://www.cdc.gov/hicpac/pubs.html APIC Practice Guidance and Topic-Specific Infection Prevention sections at http://www.apic.org AORN Standards and Recommended Practices are published annually, usually distributed in February. Recommend each IP have access to a copy of this and spend time reading it- invaluable resource! AORN includes information in most chapters aimed at Ambulatory facilities. 45 45

APIC Resources APIC 2014 Text Chapters: 31: Cleaning, Disinfection, and Sterilization 32: Reprocessing Single-Use Devices 55: Endoscopy 64: Ambulatory Surgery Centers With over 100 webinars to choose from APIC keeps you current on clinical developments, changing regulations and best practices.

Questions? marcia.patrickip@gmail.com 47 47