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

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

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

“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

“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

GI ENDOSCOPES: Shift from Disinfection to Sterilization Rutala Weber. JAMA 2014.312:1405-1406 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

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.

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 2013.26:231-254 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.

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

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

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).

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).

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

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

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

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

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

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

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

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

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

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

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

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

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

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