1. Hot Topics in Endoscope Reprocessing
Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), FAPIC Manager, Clinical Education & Cochair of AAMI WG 84 for Endoscope Reprocessing (ST91) Healthmark Industries

2. 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

3. 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
#2 - Failure to consistently and effectively reprocess flexible endoscopes—that is, failure to clean and disinfect or sterilize the instruments between uses—can lead to the spread of deadly infections.
Studies highlighting the challenges of this process, along with continuing reports of patient exposures to contaminated instruments, underscore why this topic remains a critical concern.
(We have included some version of this topic in eight of the 10 previous editions of our list.)
Areas that require particular attention include:
▪▪ The cleaning step, which is largely manual and technique-dependent. If biologic debris and other foreign material is not cleaned from the endoscope first, residual soil can harden, making subsequent disinfection ineffective.
▪▪ Instrument storage after reprocessing. Moisture trapped in the channels of an endoscope can promote the proliferation of any microbes not eradicated by reprocessing.
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—for example, through magnification-aided visual inspections and the use of biochemical testing—and (2) implement measures to dry endoscope channels after reprocessing. Additional, detailed recommendations are presented in our complete report.
#5: Exposing medical devices and other equipment to incompatible cleaning agents or unapproved cleaning methods can result in:
▪▪ Premature deterioration of a device’s nonmetallic parts, which can lead to the often imperceptible weakening and ultimate breakage of the parts, as well as other associated damage or malfunctions
▪▪ Failure of device electronics or power supplies, resulting from component damage or fluid intrusion
▪▪ Adverse effects from residual surface debris or cleaning residue
All of these occurrences can lead to device performance and safety issues, such as equipment failure, power supply interruptions, excessive and often incorrect alarms, or unexpected motion or device operation. In addition to having significant financial implications, device malfunctions and premature equipment failures can lead to patient or staff injury or compromised patient care. The need to stock and use multiple cleaning products, along with the requirement to familiarize staff with device-specific cleaning methods, is a significant burden for hospitals. Nevertheless, the risk of harm to patients and staff, and the often substantial costs to replace damaged devices,
outweighs the challenge of implementing safe and correct cleaning.

4. ECRI Endoscope Cleaning Recommendations
To achieve more reliable and effective endoscope reprocessing, ECRI Institute recommends that healthcare facilities:
Establish processes for assessing the quality of the cleaning step
a. through magnification-aided visual inspections and the use of biochemical testing and
Implement measures to dry endoscope channels after reprocessing.
Reference ECRI 2018:

5. Regulations/Standards/Guidelines
A rule or directive made and maintained by an authority
Mandatory
Standards
Requirements and specifications to ensure consistency and fit for purpose
Voluntary, but can become mandatory
Guidelines, Recommended Practices, Technical Information reports
Technical guidance, information or preferred procedures regarding a given topic
Voluntary but with interpretation

6. 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

7. 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)

8. Other Guidelines for Endoscopes
AORN: GUIDELINE FOR PROCESSING FLEXIBLE ENDOSCOPES 2016, Guidelines for Perioperative Practice. February 2016.
CDC HICPAC guideline: page last updated 1/12/2017. Accessed 3/1/2017.
ASGE, Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update
CDC, Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations, 2017.
FDA Safety Communications
Manufacturer’s IFU for scopes, AER and accessories.

9. Workflow in Endoscopy Reprocessing
ST91 & AORN:
Workflow should be unidirectional from the decontaminated area to the clean area and then to the storage area
Work flow should be designed to contain contaminants, prevent damage to endoscopes, and minimize employee exposure to blood-borne and other disease-producing organisms
Processing area separate from procedure room
Restrict traffic to authorized personnel
AORN:
1 or 2 room design with proper unidirectional workflow
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

10. 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

11. 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!
Leak proof sides and bottom
Puncture resistant
Labelled appropriately as biohazard

12. 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

13. Size of Containers
Refer to IFU of endoscope for size recommendations for transport bin
Olympus IFU:
Do not coil the scope in a diameter of less than 12cm for transport and general use:
This equates to 4.72 inches.
For colonoscopes, gastroscopes, duodenoscopes, bronchoscopes, ultrasound scopes, enteroscopes, and dual channel scopes, the recommendations is the same.
Endoscope can be damaged if coiled too tightly.
For ultrasound scopes, although the diameter of 12cm is still recommended, there is an additional caveat that the ultrasonic image may not be normal if it has been coiled too tightly.

14. Diameter for coiling - Olympus

15. Labelling clean transport bins
Clean transport bins should be wiped with a surface cleaner/disinfectant between uses
Clean bins should be labelled accordingly

16. Keep Items Moist for Transport
AORN:
V.b.2. Semicritical items should be kept wet or damp, but not submerged in liquid during transport. [3: Moderate Evidence]
Keeping the items wet helps dilute, soften, and ease removal of organic soils.
Dried organic materials and debris can make the item more difficult to clean and potentially lead to the formation of biofilm.
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.

17. 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

18. 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.

19. Delayed Reprocessing Olympus customer statement:
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

20. Single-use vs Reusable Valves
ST91, SGNA, AORN all recommend keeping reusable valves together with the scope through reprocessing
Unique identifiable set
Tracking difficult
Consequences: facilities moving to single-use valves
Concerns: sticking, set makeup, silicone based, lubricants, etc.

21. Brushes
SGNA:
Have available appropriate size channel cleaning brushes
Use a brush size compatible with each channel
Endoscope cleaning brushes should be the appropriate size that assures contact with the surface (Peterson et al., 2011; Rutala et al., 2008)
AORN:
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.
ST91 : with a cleaning brush of the length, width, and material designated in the endoscope manufacturer's written IFU.
Brush all channels according to the endoscope manufacturer’s written IFU until there is no visual debris.
NOTE 2—Cleaning brushes should either be single use and disposed of or reusable and receive high-level
disinfection or sterilization after each use, according to their written IFU.

22. 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
Protein, carbs, hemoglobin, ATP
Surveillance tests for bacteria
Culture = all types
NOW test = Gram negatives

23. Cleaning verification guidance
Current recommendations support testing of the manual cleaning process at pre-established regular intervals:
AAMI ST91: Regular intervals, i.e. Weekly or preferably daily
AORN: Regular intervals such as with EACH reprocessing cycle or daily
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.

24. What About Automated Cleaning in an AER?
Some have FDA cleared cleaning claims.
SGNA Redundant process:
“Manual cleaning and brushing are still necessary when a washer-disinfector 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.”
Manual cleaning and thorough brushing of channels are required even when AER manufacturers claim that manual cleaning is unnecessary (FDA, 2009).

25. Borescope Usage AORN and ST91 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?

26. Borescope Examination Photos
Fluid in Channel of “DRY” scope
Debris inside a channel

27. Drying AER cycles are an air purge
Scopes must be completely dry before going into storage.
Follow manual or AER cycle with instrument quality air drying.
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.
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 : 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).

28. Drying in Cabinets AORN: Drying cabinet preferred
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.

29. 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.
SGNA: Have a system in place to for identify scopes that are clean and ready to use

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

31. 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.12,14,16-18,20-22 [1: Strong Evidence]
Limiting endoscope processing activities to designated processing rooms may help prevent contamination of procedure rooms and patient care areas.22

32. 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.

33. Hang time options

34. 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

35. FDA Duodenoscope Culture Method
Released

36. 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.

37. Simethicone usage Recent research: Ofstead and associates. 2016 AJIC.
Demonstrates that simethicone residue remains inside gastrointestinal
endoscopes despite reprocessing.
Ofstead and associates AJIC.
Again, showed fluid in scopes.
European Article: All 16 scopes had crystallized simethicone

38. Simethicone Olympus statement: Fuji and Pentax state not to use
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. 
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).

39. Simethicone Use 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.”

40. What if HPV is Resistant to Aldehydes?
Most common STD
In one study, FDA-cleared HLDs had NO EFFECT on HPV
Reference:
OPA, GA HLDs had no effect
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

41. 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
Need to test FDA cleared oxidizing HLDs
If HPV is unlike all other non-enveloped viruses that are susceptible to aldehydes this will:
Upset the Spaulding classification scheme (HLD should inactivate all viruses)
Transition to other effective methods (sterilization, oxidizing agents)
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
Disinfection of both handle and probe in one step

42. TEE Probes Follow guidance in IFU for reprocessing
ST79 would be applicable standard, excluded from ST91
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.
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.
Options exist for automated disinfection
Rinse properly: According to disinfection label. Clean water rinses.
Reference: PCI medical –

43. TEE Probes
Electrical Leak Test: As of Dec 31, 2015 the Intersocietal Accreditation Committee (IAC) requires leak testing between every procedure.
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.
Hang probes vertically in a cabinet and store in a clean, dry environment. Tip guards also help protect the probe’s distal tip.

44. 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
Tracking and identification purposes
May also send for sterilization
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

45. Sterilization of endoscopes
Spaulding: Standard of care for critical and semi-critical devices
Semi-critical: If sterilization is not possible, then HLD
ST91: 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

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

47. New labelling for URF-P6 and P6R
Ureteroscope recall
Olympus letter dated 1/17/18
Scope tips can break off in patient
Also changed reprocessing instructions
Requires sterilization!
Removed HLD info
Only single use brushes
Sterile basins, sterile cloths for drying
Covering tip with a sterile cloth

48. The future!

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

50. Other hot topics Cleaning cloths/sponges are NOT reusable
Clarifying in ST91
Reusable brushes must be reprocessed between uses
Flushing pumps: Need to perform quality steps on them
Volume verification and decontamination steps
Flushing from sink water vs. flushing with fresh fluid
Leaks-fluid invasion-consequences for patients
Syringe full of water in ST91
Water quality
Non-critical vs. Critical water
Fresh detergent / cleaning vessels between scopes… 

51. References
SGNA Standards of Infection Prevention in Endoscopy, Accessed 8/23/16.
SGNA Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes, Accessed 8/23/16.
ANSI/AAMI ST91:2015. Flexible and semi-rigid endoscope processing in health care facilities.
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 Accessed 9/2/16.
HICPAC guideline; page last updated 1/12/2017. Accessed 3/1/2017.
And as noted on slides…

52. Thank you!
Q & A