Hot Topics in Endoscope Reprocessing Mary Ann Drosnock

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Hot Topics in Endoscope Reprocessing Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), FAPIC

Hot Topics in Endoscope Reprocessing Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), FAPIC Senior Manager, Clinical Education & Co-chair of AAMI ST 91 for Endoscope Reprocessing Healthmark Industries

Objectives • Update most current guidelines • Overview of latest hot topics in endoscope

Objectives • Update most current guidelines • Overview of latest hot topics in endoscope reprocessing • Discuss the future of sterilized endoscopes and other endoscope trends and technology

The ECRI 2018 List 1. Ransomware and Cybersecurity Threats Can Endanger Patients 2. Endoscope

The ECRI 2018 List 1. Ransomware and Cybersecurity Threats Can Endanger Patients 2. Endoscope Reprocessing Failures Continue to Expose Patients to Infection Risk 3. Mattresses and Covers May Be Infected by Body Fluids and Microbiological Contaminants 4. Missed Alarms May Result from Inappropriately Configured Secondary Notification Devices and Systems 5. Improper Cleaning May Cause Device Malfunctions, Equipment Failures, and Potential for Patient Injury 6. Unholstered Electrosurgical Active Electrodes Can Lead to Patient Burns 7. Inadequate Use of Digital Imaging Tools May Lead to Unnecessary Radiation Exposure 8. Workarounds Can Negate the Safety Advantages of Bar -Coded Medication Administration Systems 9. Flaws in Medical Device Networking Can Lead to Delayed or Inappropriate Care

ECRI Endoscope Cleaning Recommendations • To achieve more reliable and effective endoscope reprocessing, ECRI

ECRI Endoscope Cleaning Recommendations • To achieve more reliable and effective endoscope reprocessing, ECRI Institute recommends that healthcare facilities: 1. Establish processes for assessing the quality of the cleaning step a. through magnification-aided visual inspections and the use of biochemical testing and 2. Implement measures to dry endoscope channels after reprocessing. Reference ECRI 2018: https: //www. ecri. org/Resources/Whitepapers_and_reports/Haz_18. pdf

NEWS! Transmission of Mobile Colistin Resistance (mcr-1) by Duodenoscope • The first healthcare-associated transmission

NEWS! Transmission of Mobile Colistin Resistance (mcr-1) by Duodenoscope • The first healthcare-associated transmission of mcr-1 in the United States was associated with shared exposure to a duodenoscope, despite implementation of updated reprocessing instructions and supplemental measures; this represents the first documented duodenoscope-linked transmission since publication of updated reprocessing guidelines. • Evaluation of the duodenoscope identified an area at the distal tip where adhesive had peeled off; after disassembly, foreign material was detected on the interior of the distal case and at the distal tip of the duodenoscope body. o • VISUAL INSPECTION!! Shenoy, 2018. Published by Oxford University Press for the Infectious Diseases Society of America. Downloaded from https: //academic. oup. com/cid/advance-articleabstract/doi/10. 1093/cid/ciy 683/5094756 by guest on 12 September 2018.

What is ANSI/AAMI ST 91? • Flexible and semi-rigid endoscope reprocessing in health care

What is ANSI/AAMI ST 91? • Flexible and semi-rigid endoscope reprocessing in health care facilities • Contains best practices for scope reprocessing in ANY setting • Excludes TEE/ultrasound probes http: //www. aami. org/productspublications/Product. Detail. aspx? Item. Number=2477

What are the SGNA Guidelines? SGNA Standards and Practice Guidelines: 1. Guideline for Use

What are the SGNA Guidelines? SGNA Standards and Practice Guidelines: 1. Guideline for Use of High-Level Disinfectants & Sterilants in the Gastroenterology Setting (2017) 2. Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes (2016) 3. Standard of Infection Prevention in the Gastroenterology Setting (2015) https: //www. sgna. org/Practice/Standards. Practice-Guidelines

 • Other Guidelines for Endoscopes AORN: GUIDELINE FOR PROCESSING FLEXIBLE ENDOSCOPES 2016, Guidelines

• Other Guidelines for Endoscopes AORN: GUIDELINE FOR PROCESSING FLEXIBLE ENDOSCOPES 2016, Guidelines for Perioperative Practice. February 2016. • CDC HICPAC guideline: https: //www. cdc. gov/hicpac/pubs/flexibleendoscope-reprocessing. html, page last updated 1/12/2017. Accessed 3/1/2017. • ASGE, Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. 2017. • https: //www. asge. org/docs/defaultsource/education/practice_guidelines/2016_ms_repr ocessing_flexible_endoscopes. pdf? sfvrsn=8 CDC, Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations, 2017. • FDA Safety Communications • Manufacturer’s IFU for scopes, AER and accessories.

Workflow in Endoscopy Reprocessing • ST 91 & AORN: o Workflow should be unidirectional

Workflow in Endoscopy Reprocessing • ST 91 & AORN: o Workflow should be unidirectional from the decontaminated area to the clean area and then to the storage area o Work flow should be designed to contain contaminants, prevent damage to endoscopes, and minimize employee exposure to blood-borne and other disease-producing organisms o Processing area separate from procedure room o Restrict traffic to authorized personnel • AORN: o 1 or 2 room design with proper unidirectional workflow o Single room design should have a minimum of 3 ft between the decontamination area and the clean work area and either a separating wall or a barrier that extends a minimum of 4 ft above the sink rim to separate soiled work areas from clean work areas

Labelling clean transport bins • Clean transport bins should be wiped with a surface

Labelling clean transport bins • Clean transport bins should be wiped with a surface cleaner/disinfectant between uses o Check IFU of container for compatible chemistries • Clean bins should be labelled accordingly

Contaminated Transport • From procedure room to reprocessing area • Closed, labeled transport containers

Contaminated Transport • From procedure room to reprocessing area • Closed, labeled transport containers • Place a single endoscope in a container by naturally coiling it in large loops. • Separate endoscopy accessories. • Governed by OSHA regulation! o Leak proof sides and bottom o Puncture resistant o Labelled appropriately as biohazard

AORN Transport Verbiage • V. b. After precleaning at the point of use or

AORN Transport Verbiage • V. b. After precleaning at the point of use or after use, personnel must transport contaminated items to be prepared for high-level disinfection in a closed container or closed transport cart. [1: Regulatory Requirement] • Transporting items to the decontamination area in a manner that prevents exposing personnel to blood, body fluids, and other potentially infectious materials is a regulatory requirement. • V. b. 1. The container or cart must be leak proof, puncture resistant, large enough to contain all contents, & labeled with a fluorescent orange or orange red label containing a biohazard legend • Securing and labeling containers of biohazardous material is a regulatory requirement and communicates to others that the contents may be biohazardous

Size of Containers • Refer to IFU of endoscope for size recommendations for transport

Size of Containers • Refer to IFU of endoscope for size recommendations for transport bin • http: //www. healthmark. info/Instrument. Retriev al/SSTTray. Systems/Flex. Endo_Transport. pdf • Olympus IFU: o Do not coil the scope in a diameter of less than 12 cm for transport and general use: • This equates to 4. 72 inches. o For colonoscopes, gastroscopes, duodenoscopes, bronchoscopes, ultrasound scopes, enteroscopes, and dual channel scopes, the recommendations is the same. o Endoscope can be damaged if coiled too tightly. o For ultrasound scopes, although the diameter of 12 cm is still recommended, there is an additional caveat the ultrasonic image may not be normal if it has been coiled too tightly.

Diameter for coiling Olympus

Diameter for coiling Olympus

Keep Items Moist for Transport • AORN: o V. b. 2. Semicritical items should

Keep Items Moist for Transport • AORN: o V. b. 2. Semicritical items should be kept wet or damp, but not submerged in liquid during transport. [3: Moderate Evidence] o Keeping the items wet helps dilute, soften, and ease removal of organic soils. o Dried organic materials and debris can make the item more difficult to clean and potentially lead to the formation of biofilm. o Submerging the device in liquid during transport may increase the risk of spillage and could lead to fluid invasion if the device has an unknown leak. • ST 79: Prior to transport, keep instruments moist. They prepared in such a way as to prevent organic soils from drying by placing a towel moistened with water (not) over the instrument; • placing items inside a package designed to maintain humid conditions; or • applying a product designed for pretreatment. o Long delays in processing can result in the formation of tenacious and difficult-toremove biofilm that will shield microorganisms from routine cleaning procedures and possibly interfere with disinfection or sterilization.

Leak Testing – Order is important! Connect air source to endoscope and turn ON

Leak Testing – Order is important! Connect air source to endoscope and turn ON Fully immerse endoscope in WATER Wipe air bubbles from surface Angulate distal end and push buttons Remove endoscope from water Release pressure from endoscope

Remember you have 1 hour to Manually Clean! • Note procedure end time/precleaning start

Remember you have 1 hour to Manually Clean! • Note procedure end time/precleaning start time • Convey that time to reprocessing staff • AORN: IV. d. 3. A procedure should be developed and implemented for recording the times that the procedure is completed and cleaning is initiated. • A process for recording the times that the procedure ended and cleaning was initiated enables processing personnel to ascertain how long the endoscope has been awaiting processing, to establish priority order, and to determine whether routine processing within the manufacturer’s recommended time to cleaning is achievable, and if not, to implement the manufacturer’s procedures for delayed processing.

Delayed Reprocessing • Olympus customer statement 2018: https: //www. olympusconnect. com/assets/2/delayedreprodiff icultoclean. pdf Reprocessing

Delayed Reprocessing • Olympus customer statement 2018: https: //www. olympusconnect. com/assets/2/delayedreprodiff icultoclean. pdf Reprocessing Manuals: Presoak for Excessive Bleeding and/or Delayed Reprocessing” • 1 hour hold time between precleaning & manual cleaning, and between manual cleaning & high-level disinfection • IFU: Soak for up to 1 hour surgical scopes & up to 10 hours for GI scopes

Single-use vs Reusable Valves • No requirement to use single-use valves • If using

Single-use vs Reusable Valves • No requirement to use single-use valves • If using reusable valves, must clean according to IFU o Very difficult to clean • ST 91, SGNA, AORN all recommend keeping reusable valves together with the scope through reprocessing o Unique identifiable set o Tracking difficult • Consequences: facilities moving to single-use valves o Concerns: sticking, set makeup, silicone based, lubricants, etc.

Single-use vs Reusable Valves STEPS per IFU: • Immerse accessories in the detergent solution

Single-use vs Reusable Valves STEPS per IFU: • Immerse accessories in the detergent solution • Wipe and clean the external surfaces of all accessories in the detergent solution, using a clean, lint-free cloth or sponge • Brush the interior and openings of the valves until debris can no longer be seen • Depress and release pistons of valves several times • Flush interiors, openings, springs, backs of the skirts, and the holes of all accessories with the detergent solution until no air bubbles can be seen • Leave all accessories immersed in the detergent solution, according to the instructions of the detergent manufacturer. • Remove all accessories from the detergent solution and inspect them. If debris remains on any accessory, ultrasonically clean it at 33 – 48 k. Hz for 5 minutes.

Processing of endoscope accessories • Processing of certain endoscope components (valves) requires the same

Processing of endoscope accessories • Processing of certain endoscope components (valves) requires the same level of inspection, cleaning, and HLD or sterilization as the endoscope itself • Kept together with scope as unique set o Tracking and identification purposes o May also send for sterilization o Or use single use valves • Process for manual cleaning & HLD of accessories is outlined • Water bottle processing should occur according to manufacturer’s IFU and at least daily

24 -Hour Multi-Patient Use Endoscope Connectors • – FDA Safety Alert – 4/18/2018 o

24 -Hour Multi-Patient Use Endoscope Connectors • – FDA Safety Alert – 4/18/2018 o https: //www. fda. gov/Safety/Med. Watch/Safety. Information/Safety. Alertsfor. Human. Me dical. Products/ucm 604940. htm o Used to connect the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing o FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use o Certain marketed 24 -hour multi-patient use endoscope connectors do not include a backflow prevention feature o Connector do not adequately mitigate the risks of cross-contamination for endoscopy patients. • FDA encourages health care providers and facilities to: o use single-use endoscope connectors with backflow prevention features o use reusable endoscope connectors with backflow prevention features, and ensure that those reusable connectors are reprocessed according to their instructions for use prior to each patient procedure.

24 -Hour Multi-Patient Use Endoscope Connectors • During the procedure, the physician or nurse

24 -Hour Multi-Patient Use Endoscope Connectors • During the procedure, the physician or nurse will either flush water manually with a syringe to feed the auxiliary water channel or they will hook it up to a flushing pump. • Do not use 24 -hour multi-patient use endoscope connectors because they carry a risk of cross-contamination.

Brushes • SGNA: o Have available appropriate size channel cleaning brushes o Use a

Brushes • SGNA: o Have available appropriate size channel cleaning brushes o Use a brush size compatible with each channel o Endoscope cleaning brushes should be the appropriate size that assures contact with the surface (Peterson et al. , 2011; Rutala et al. , 2008) • AORN: o VI. g. All accessible channels and the distal end of the endoscope should be cleaned with a cleaning brush of the length, width, and material recommended by the endoscope manufacturer.

SGNA Reprocessing Steps 1. Precleaning; 2. Leak testing; 3. Manual cleaning; 4. Rinse after

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

Cleaning Verification • Residual organic soil and microbial contamination may be present on an

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

Cleaning verification guidance • Current recommendations support testing of the manual cleaning process at

Cleaning verification guidance • Current recommendations support testing of the manual cleaning process at pre-established regular intervals: o AAMI ST 91: 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.

Endoscope Visual Inspection • • Minimum standard of care for endoscopes Visual inspection is

Endoscope Visual Inspection • • Minimum standard of care for endoscopes Visual inspection is recommended to make sure the endoscope is visibly clean. CDC on Visual Inspection: After manual cleaning, visually inspect the endoscope & accessories. Visual inspection provides additional assurance that the endoscope and its accessories are clean and free of defects. Complex devices such as flexible endoscopes may require the use of lighted magnification or additional methods to assist with the inspection process. SGNA: Treat as a safety stop or “time out” to ensure the endoscope is visually clean before proceeding to the next step of HLD.

Borescope Usage • AORN and ST 91 recommend, not require • Internal channels of

Borescope Usage • AORN and ST 91 recommend, not require • Internal channels of endoscopes may be inspected using a borescope. Borescopes penetrate the lumen and allow for improved visual inspection. • When to use it?

What About Automated Cleaning in an AER? • Some have FDA cleared cleaning claims.

What About Automated Cleaning in an AER? • Some have FDA cleared cleaning claims. • SGNA Redundant process: o “Manual cleaning and brushing are still necessary when a washerdisinfector is used in order to assure the overall efficacy of HLD. The redundancy achieved by adding an automated washing step following manual cleaning can undoubtedly provide an extra level of safety. Users are cautioned about dispensing with manual cleaning endoscope reprocessing and brushing steps before the capabilities of the new machines are confirmed in independent studies and in clinical practice. ” o Manual cleaning and thorough brushing of channels are required even when AER manufacturers claim that manual cleaning is unnecessary (FDA, 2009).

More info on Drying • Scopes must be completely dry before going into storage.

More info on Drying • Scopes must be completely dry before going into storage. • Follow manual or AER cycle with instrument quality air drying. o AER cycles are an air purge • AORN: The endoscope channels should be dried by purging with instrument air or mechanically dried with a mechanical processor drying system. • SGNA: An endoscope that is not dry must be reprocessed before use. • How do you know its dry? o Inspect with borescope o Use a drying test

Drying o Exterior surfaces should be dried with a soft, lint-free cloth & channels

Drying o Exterior surfaces should be dried with a soft, lint-free cloth & channels purged with instrument air. • Sterile wipes? Sterile swabs? Sterile gloves? o 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) o AORN: Wear clean gloves when handling processed scopes and when transporting them to and from the storage cabinet.

Drying in Cabinets • AORN: Drying cabinet preferred o If not, then cabinet with

Drying in Cabinets • AORN: Drying cabinet preferred o If not, then cabinet with HEPA filtered air • SGNA: Since drying does not rely on gravity, the endoscopes can be stored horizontally or vertically depending on the design of the cabinet. o Can not rely on hanging to dry! • Cabinet maintenance o Check with manufacturer o Have it proceduralized

Labelling for identification • AORN: Scopes should be clearly identified with a distinct visual

Labelling for identification • AORN: Scopes should be clearly identified with a distinct visual cue as processed and ready for use. • ST 91: Develop protocols to ensure that users can readily identify an endoscope that has been processed and is ready for patient use. • SGNA: Have a system in place to for identify scopes that are clean and ready to use

Location of cabinets Not in procedure room AAMI and SGNA: The reprocessing room is

Location of cabinets Not in procedure room AAMI and SGNA: The reprocessing room is a designated area that is dedicated to reprocessing. It must be a room that is separate from where endoscopic procedures are performed AORN: Flexible endoscopes should be processed in an area designed and constructed to support processing activities. I. a. Except for precleaning processes performed at the point of use, endoscope processing should occur in a room where only processing activities are performed and that is physically separated from locations where patient care activities are performed. Limiting endoscope processing activities to designated processing rooms may help prevent contamination of procedure rooms and patient care areas.

Current recommendations for length of storage “hang time” • AAMI ST 91: Due to

Current recommendations for length of storage “hang time” • AAMI ST 91: 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.

How to do a risk assessment • Risk assessment should be performed to address

How to do a risk assessment • Risk assessment should be performed to address length of storage (hangtime) 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 Chart in ST 91 o Now in alignment with AORN recommendations to conduct a risk assessment

Hang time label options – Distinct visual cue

Hang time label options – Distinct visual cue

Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication - August 4, 2015 Provides

Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication - August 4, 2015 Provides a list of supplemental duodenoscope reprocessing measures that facilities can use in addition to current IFUs for additional risk mitigation. • Microbiological Culturing • Ethylene Oxide Sterilization • Use of a Liquid Chemical Sterilant Processing System • Repeat High-Level Disinfection https: //www. fda. gov/safety/medwatch/safetyinformation/saf etyalertsforhumanmedicalproducts/ucm 457132. htm

Microbial Surveillance • Options include: o Traditional culturing o Gram negative test kits •

Microbial Surveillance • Options include: o Traditional culturing o Gram negative test kits • Not ATP or cleaning verification tests • 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 • SGNA: Surveillance cultures can be used as a method for assessing reprocessing quality and aid in identifying particular endoscope defects that hamper effective reprocessing

FDA Duodenoscope Culture Method • Released 2 -26 -18 • Validated method • Supersedes

FDA Duodenoscope Culture Method • Released 2 -26 -18 • Validated method • Supersedes the CDC Interim Method • Flush – brush – flush method (sterile water) • Recommends a neutralizer broth and longer incubation time • https: //www. fda. gov/downloads/Medical. Devices/Productsand. Medical. Pr ocedures/Reprocessingof. Reusable. Medical. Devices/UCM 597949. pdf

SGNA on Culturing • Routine culturing of endoscopes following reprocessing is not currently recommended

SGNA on Culturing • Routine culturing of endoscopes following reprocessing is not currently recommended in the United States but may be considered in the event of an identified outbreak. • Surveillance cultures can be used as a method for assessing reprocessing quality and aid in identifying particular endoscope defects that hamper effective reprocessing. Society of Gastroenterology Nurses and Associates Inc.

Monitoring for Gram-negative organisms • • Rapid (12 hour) surveillance test Detects enzymes specific

Monitoring for Gram-negative organisms • • Rapid (12 hour) surveillance test Detects enzymes specific to Gram-negative bacteria generating fluorescence ST 91: Types of verification testing may include enzyme based tests Recent peer-reviewed study o Washburn and Pietsch, “Assessment of test methods for evaluating effectiveness of cleaning flexible endoscopes” AJIC 2017. Article in Press.

How is this different than Cleaning Verification? • Surveillance is not ATP • Cleaning

How is this different than Cleaning Verification? • Surveillance is not ATP • Cleaning verification = after manual cleaning process • Surveillance = after AER / in storage, not after manual cleaning • Cleaning verification tests for residual debris o Protein, carbs, hemoglobin, ATP • Surveillance tests for bacteria o Culture = all types o NOW test = Gram negatives

Simethicone usage • Recent research: o Ofstead and associates. 2016 AJIC. • Demonstrates that

Simethicone usage • Recent research: o Ofstead and associates. 2016 AJIC. • Demonstrates that simethicone residue remains inside gastrointestinal endoscopes despite reprocessing. • http: //www. ajicjournal. org/article/S 0196 -6553(16)305818/abstract o Ofstead and associates. 2017 AJIC. • Again, showed fluid in scopes. • http: //www. ajicjournal. org/article/S 0196 -6553(16)30970 -1/pdf o European Article: All 16 scopes had crystallized simethicone • https: //www. thiemeconnect. com/products/ejournals/pdf/10. 1055/s-0042 -120261. pdf

Simethicone • Olympus statement 2018: o Olympus does not recommend the use of non-water

Simethicone • Olympus statement 2018: o Olympus does not recommend the use of non-water soluble additives with our flexible endoscopes or ancillary equipment. These products may be difficult to remove during manual cleaning and may reduce the efficacy of the reprocessing procedure. Simethicone and petroleum/oil/silicone-based lubricants are non-water soluble and thus not recommended for use by Olympus. • Fuji and Pentax state not to use • ASGE: Findings from Ofstead are preliminary. Clinical significance is unclear. ASGE does not have any evidence to make recommendations to change current clinical practice. o http: //www. asge. org/uploaded. Files/Publications_and_Products/Simethic one%20 final. pdf o https: //www. asge. org/docs/default-source/practice-support/practiceresources/simethicone-final. pdf

Simethicone Use • SGNA: Simethicone, often used during endoscopy procedures, may foster microbial growth

Simethicone Use • SGNA: Simethicone, often used during endoscopy procedures, may foster microbial growth and biofilm development despite proper reprocessing because it contains sugars and thickeners. Minimize use of simethicone pending further studies (Ofstead et al. , 2016). https: //www. sgna. org/Portals/0/HLD__FINAL. pdf • Represents an off-label use of the simethicone drops. • ASGE: Not an approved prep listed in their guidelines: “ Simethicone promotes the clearance of excessive gas in the GI tract that reduces bloating, abdominal discomfort, and abdominal pain and improves visualization in the GI tract. There have been several studies investigating the addition of simethicone to bowel preparation regimens. Overall, simethicone does not significantly change the quality of the bowel preparation; however, it does reduce the number of adherent bubbles present, which may enhance colonic visualization. ” https: //www. asge. org/docs/defaultsource/education/practice_guidelines/docbowel_prep_before_colonoscopy. pdf

What if HPV is Resistant to Aldehydes? • Most common STD • In one

What if HPV is Resistant to Aldehydes? • Most common STD • In one study, FDA-cleared HLDs had NO EFFECT on HPV o Reference: https: //www. ncbi. nlm. nih. gov/pubmed/24500190 o OPA, GA HLDs had no effect o The study showed that high concentrations of hypochlorite and peracetic acid (PAA) with silver were effective within the contact time. • Problem with study: Neither of these are FDA cleared HLDs for medical use • Findings inconsistent with other small, non-enveloped viruses such as polio, rhino, echo • Further investigation needed: test methods unclear • Need to test FDA cleared HLDs for disinfection of medical devices not formulations that aren’t currently cleared or available

HPV • CDC currently states to validate and use HLD consistent with FDA-cleared instructions

HPV • CDC currently states to validate and use HLD consistent with FDA-cleared instructions (no alterations required at this point) • More studies are on-going at this time to corroborate or refute study findings o Need to test FDA cleared oxidizing HLDs • If HPV is unlike all other non-enveloped viruses that are susceptible to aldehydes this will: o Upset the Spaulding classification scheme (HLD should inactivate all viruses) o Transition to other effective methods (sterilization, oxidizing agents) o If oxidizing agents kill HPV (then transition to PA or HP alone or in combination) • Trophon system – 7 minute HLD cycle – automated hydrogen peroxide mist system o Disinfection of both handle and probe in one step o www. nanosonics. us

TEE Probes • • Follow guidance in IFU for reprocessing ST 79 would be

TEE Probes • • Follow guidance in IFU for reprocessing ST 79 would be applicable standard, excluded from ST 91 Long insertion tube difficult to disinfect because of its length and thus vulnerable to damage FDA: a probe cover or sheath is required every time a probe is used in a semi-critical application. OEM’s recommend use of a probe cover. o Some OEM’s recommends a sterile sheath in addition to patient bite blocks. • • • Precleaning: Performed at bedside Manual cleaning must be performed using detergent solution. Manual disinfection: soak for the time advised by the label. o • Options exist for automated disinfection Rinse properly: According to disinfection label. Clean water rinses. Reference: PCI medical – www. pcimedical. com

TEE Probes • Electrical Leak Test: As of Dec 31, 2015 the Intersocietal Accreditation

TEE Probes • Electrical Leak Test: As of Dec 31, 2015 the Intersocietal Accreditation Committee (IAC) requires leak testing between every procedure. o Damaged probes can lead to black mouth (chemical burning due to improperly rinsed disinfectant) or an electrical shock to the patient (with the probe only inches from the patient’s heart). • STORAGE: Joint Commission recommends storing probes in a manner to protect them from damage and contamination. o Hang probes vertically in a cabinet and store in a clean, dry environment. Tip guards also help protect the probe’s distal tip.

Sterilization of endoscopes • Spaulding: Standard of care for critical and semi-critical devices o

Sterilization of endoscopes • Spaulding: Standard of care for critical and semi-critical devices o Semi-critical: If sterilization is not possible, then HLD • ST 91: special considerations for terminal sterilization with primary source of info being endoscope’s IFU • More modalities compatible with surgical flexible endoscopes • Sterilization is dependent on adequate cleaning, drying and device preparation

Sterilization • Surgical scopes = many compatible with vaporized hydrogen peroxide systems o STERRAD

Sterilization • Surgical scopes = many compatible with vaporized hydrogen peroxide systems o STERRAD in Olympus IFUs o V-Pro not in IFU, found in customer letters Except for new BF-MP 190 F • ETO compatible with all Olympus scopes o Found in manual • Sterilization is dependent on adequate cleaning, drying and device preparation • Store flat in wrap according to hospital policy

New labelling for URF-P 6, URF-P 6 R, V, V 2 R • •

New labelling for URF-P 6, URF-P 6 R, V, V 2 R • • Ureteroscope recall Olympus new manuals and letter dated 1/17/18 o Scope tips can break off in patient o Also changed reprocessing instructions • Requires sterilization! • Removed HLD info • Inspection required prior to use • Inspect the endoscope for residual debris. Should any debris remain, repeat the entire cleaning procedure until all debris is removed.

Develop an action plan for sterilization • Inventory scopes – what models do you

Develop an action plan for sterilization • Inventory scopes – what models do you have • Look at compatibility with sterilization methods • Move all scopes that can be easily sterilized to sterilization! o Surgical flexible scopes, ie Bronchoscopes, ureteroscopes, cysto, hystero, ENT, etc. • Look at remaining scope inventory (GI scopes) o Prioritize by risk (eg duodenoscopes) o Based on FDA recommendations, do something • Sterilize, culture, liquid chemical sterilization, double HLD • May need to adjust inventory levels of scopes

The future!? • Single-use Scopes • Better cleaning technology • Change in scope design

The future!? • Single-use Scopes • Better cleaning technology • Change in scope design / compatibility

Other hot topics • Cleaning cloths/sponges are NOT reusable o Clarifying in ST 91

Other hot topics • Cleaning cloths/sponges are NOT reusable o Clarifying in ST 91 • Reusable brushes must be reprocessed between uses • Flushing pumps: Need to perform quality steps on them o Volume verification and decontamination steps • Flushing from sink water vs. flushing with fresh fluid • Leaks-fluid invasion-consequences for patients o Syringe full of water in ST 91 • Water quality o Non-critical vs. Critical water • Fresh detergent / cleaning vessels between scopes…

References • • SGNA Standards of Infection Prevention in Endoscopy, 2015. Accessed 8/23/16. http:

References • • SGNA Standards of Infection Prevention in Endoscopy, 2015. Accessed 8/23/16. http: //www. sgna. org/Portals/0/Standard%20 of%20 Infection%20 Prevention_FI NAL. pdf SGNA Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes, 2016. Accessed 8/23/16. http: //www. sgna. org/Portals/0/Standards%20 for%20 reprocessing%20 endosc opes_FINAL. pdf ANSI/AAMI ST 91: 2015. Flexible and semi-rigid endoscope processing in health care facilities. www. 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 00382. asp HICPAC guideline; https: //www. cdc. gov/hicpac/pubs/flexible-endoscopereprocessing. html, page last updated 1/12/2017. Accessed 3/1/2017. And as noted on slides…

My contact information: Mary Ann Drosnock Cell: 586 -5322 1 -800 -521 -6224/Ext. 6005

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