1. OUR RESPONSIBILITY TO THE FUTURE
Disinfection and Sterilization
“The Good, The Bad and The Ugly”
OUR RESPONSIBILITY TO THE FUTURE
Presentation by
William Rutala, PhD, MPH:
University North Carolina Healthcare
Also referenced
Flexible Endoscope Reprocessing and the Importance of AAMI ST91 presentation by Mary Drosnock fromHealthmark Industries
Summary by Barb Keller RN BSN CIC

2. Objectives State two endoscope reprocessing challenges.
Identify three recommendations for duodenoscopes to prevent Outbreaks

3. Disinfection and Sterilization
Our Responsibility to the Future
Prevent All Infectious Disease Transmission by Instruments and the Environment in 5 years.
HOW
Research AND Technology
Automation AND Competency

4. “The Good, The Bad and The Ugly”
Sterilization Enormous Margin of Safety!
100 quadrillion margin of safety
Sterilization kills 1 trillion spores compared to
Washer/disinfector removes or inactivates 10 – 100 million

5. “The Good, The Bad and The Ugly” Five Year Plan: Research and Technology
Sterilization-highly effective
High-Level Disinfection –challenge #1
* Eliminate endoscope-related infections, promote automation, research (scopes), sterilization
Low-Level Disinfection – challenge #2
* Eliminate environment as source of infection: “no touch” room decontamination methods; continuous decontamination

6. GI ENDOSCOPES: Shift from Disinfection to Sterilization
Rutala Weber. JAMA :
Endemic Transmission of Infections Associated with GI Endoscopes Likely Go Unrecognized
Inadequate surveillance of outpatient procedures for HAI’s
Long lag time between colonization and infection
Pathogens usual enteric flora
Rutala, Weber. Am J Infect Cont.2016;44:e1-e6
Rutala, Weber ICHE.2015;36:643

7. Disinfection and Sterilization Endoscopes
Endoscopes top ECRI’s list of 10 health technology hazards
Multiple Outbreaks documented in literature from:
UGI: 19 Outbreaks/169 pts. Contaminated
Sigmoid/Colonoscopy: 5 Outbreaks/14 pts. Contaminated
ERCP: 23 Outbreaks/ 152 pts contaminated
Bronchoscopy: 51 Outbreaks/ 778 pts contaminated.

8. Disinfection and Sterilization Endoscopes
Based on outbreak data, if eliminated deficiencies associated with cleaning, disinfection, automated endoscopic reprocessing (AER), contaminated water and drying would eliminate about 85% of the outbreaks.
Kovaleva et al. Clin Microbiol Rev :
Additional outbreaks from duodenoscopes (not published)
UCLA, 2015, CRE, 179 pts.
CMC, 2015, CRE, 18 pts.
Cedars-Sinai, 2015, CRE, 67 pts
Wisconsin, 2013, CRE, 5 pts.
Univ. Pittsburg, 2012, CRE 9 pts.

9. Disinfection and Sterilization Endoscope Reprocessing
New Guidelines:
Multi-society guideline (in prep)
AORN-2016
AAMI-2105
SGNA-2015
Must educate/comply but Rutala is confident that will not prevent all infections and patient exposures due to microbial load and instrument complexity

10. Highlights of AAMI ST91 AAMI Presentation
Gives recommendation for:
* Certifications for technicians performing reprocessing
* Monitoring the manual cleaning process
* Monitoring the automatic cleaning process
* Monitor water quality
* Monitor temperature
* After cleaning, all detachable valves should be kept together with the same endoscope as a unique set
Risk Assessment
Proper documentation and quality assurance parameters

11. Disinfection and Sterilization
EH Spaulding believed that how an object will be disinfected depended on the object’s intended use (developed in 1968)
CRITICAL: objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile.
SEMICRITICAL: objects that touch mucous membranes or skin that is not intact require a disinfection proceed (high- level disinfection that kills all microorganisms but high numbers of bacterial spores.
NONCRITICAL: objects that touch only intact skin require low-level disinfection (or non-germicidal detergent).

12. Disinfection and Sterilization Rutala, Weber. Am J Infect Control
Disinfection and Sterilization Rutala, Weber. Am J Infect Control. 2016;44:e1-e6; Rutala, Weber ICHE. 2015;36:643
EH Spaulding believed that how an object will be disinfected depended on the object’s intended use (now modified)
CRITICAL: objects which directly or secondarily (i.e., via a mucous membrane such as duodenoscope, cystoscope, bronchoscope) enter normally sterile tissue or the vascular system or through which blood flows should be sterile.
SEMICRITICAL: objects that touch mucous membranes or skin that is not intact require a disinfection proceed (high-level disinfection that kills all microorganisms but high numbers of bacterial spores.
NONCRITICAL: objects that touch only intact skin require low- level disinfection (or non-germicidal detergent).

13. Supplemental Measure to Enhance Duoedenoscope Reprocessing: FDA Safety Communication Date Issued: August 4, 2015
Reprocess using strict adherence to manufacturer’s instructions
All 3 manufacturers have released revised reprocessing instructions
Facilities performing ERCP should evaluate whether they have the expertise, training and resources to implement one or more supplemental measures
Microbiological culturing
Ethylene oxide sterilization
Liquid chemical sterilant (Peracetic acid )
Repeat high level disinfection x2

14. Validated Reprocessing Instructions
Olympus, Fujifilm and Pentax have all updated their validation reprocessing instructions to include:
Manufacturer-specific
Detailed brushing instructions
Increased flushing
Staff training

15. Highlights: CDC Surveillance Culture Protocol (AAMI presentation)
Timing: At least every 4 weeks or 60 procedures
* Or after each procedure or weekly (on Friday)
* Option to hold duodenoscopes prior to culture results
Organisms: Defines high-concern and low concern organisms
* High-concern- more associated with disease (enteric gram negative bacilli, Enterococcus spp. ) or from patients
* Low-concern- less often associate with disease; potentially a result of contamination during collection (i.e. CNS)
Areas to target (minimum)
* Area around the elevator mechanism
* Instrument channel

16. Features of Endoscopes that Predispose to Disinfection Failures
Heat labile
Long, narrow lumens
Right angle bends
Rough or pitted surfaces
Springs and valves
Damaged channels may impede microbial exposure to HLD
Heavily contaminated with pathogens, 10 to 7-10th power
Cleaning and HLD is essential for patient safe instrument

17. How Can We Prevent ERCP-Related Infections?
No single, simple and proven technology or prevention strategy that hospitals can use to guarantee patient safety.
Must continue to emphasize the enforcement of evidenced-based practices, including equipment maintenance and routine audits with at least yearly competency testing of reprocessing staff
Must do more or additional outbreaks will continue

18. Current Enhanced Methods for Reprocessing Duodenoscopes
Hospitals performing ERCPs should do one of the following (priority ranked); doing nothing is not an option
Ethylene oxide sterilation after high level disinfection with periodic microbiologic surveillance (UNC hospitals)
Double high level disinfection with periodic microbiologic surveillance
High-level disinfection with scope quarantine until negative culture
Liquid chemical sterilant processing system using peracetic acid (rinsed with extensively teated potable water) with periodic microbiolic surveillance
High-level disinfection with periodic microbiologic surveillance

19. Some Potential Sterilzation Technologies for Duodenoscopes
Optimize existing low-temperature sterilization technology
* Hydrogen peroxide gas plasma
* Vaporized hydrogen peroxide
* Ethylene oxide
Potential new low-temperature sterilization technology
* Ozone plus hydrogen peroxide vapor
* Nitrogen dioxide
* Supercritical CO2
* Peracetic acid vapor
Steam sterilization for heat-resistant endoscopes

20. The Good Sterilization-highly effective High-level disinfection
Biological indicators, emerging technologies, sterilization endoscopes
High-level disinfection
Endoscope-related infections will promote automation and sterilization
Low-level disinfection
Eliminate environment as source “No touch” room decontamination, new germicides, continuous room decontamination

21. The Bad Improve instrument reprocessing Competency
Compliance with evidence-based guidelines
Research Technology Automation

22. The Ugly INFECTION RISKS Endoscopes
Human Papilloma Virus HPV: Questioning our current high level disinfectants ability to kill HPV.

23. Sterilization-Highly Effective
Five Year Plan to Prevent Infections Associated with Instruments and Environment
Sterilization-Highly Effective
Comply with IFU/guidelines, competency, implement technologies/research
High-Level Disinfection-no margin of safety
Transition to sterilization (margin of safety) will require new technology, research (HPV), automation and competency

24. Low-Level Disinfection
Five Year Plan to Prevent Infections Associated with Instruments and Environment
Low-Level Disinfection
Eliminate environment as source of HA pathogens by “no touch” room decontamination methods; continuous room decontamination; new surface disinfection technology

25. IN SUMMARY
FDA, CDC, AAMI, AORN all have weighed in with updated recommendations
The expectation for manufacturers is to have scopes that can be sterilized – the companies are working on this
Facilities that do these procedures have the responsibility to put in place equipment, procedures, training and competency to protect the patient

26. Thank You SF APIC from Charlotte N.C. Home of Nascar