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1. Understand the patient risk related to contamination of fl exible endoscopes.

2. Describe the defi nitions and intent of Spaulding’s classifi cations and review how it relates to requirements for the reprocessing of the medical device.

3. Understand the differences between terminal sterilization and liquid chemical disinfection/sterilization processes.

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Sterilization of fl exible F

lexible endoscopes are complex medi- cal devices and important tools for the diagnosis and/or treatment of a wide variety of patient health problems. These types of devices enter the patient typically through an existing opening or orifi ce and are used for both diagnostic (colonoscopy) and therapeutic (endoscopic retrograde cholangiopancreatography or ERCP, bowel resection, tumor excision using endoscopic ultrasound or EUS, etc.) procedures. Flex- ible endoscopes are complex devices constructed with multiple materials and components including optics, electronics, and multiple polymers and are designed with complex geometries and mechanical functions that are typically not compat- ible with steam sterilization but require low temperature chemical disinfection or sterilization processes. Endoscopes can be quite costly, and many health care facilities strive for maximum utilization of these devices necessitating fast turnaround time for reprocessing.

Historically, it was believed that the risk for endoscopy-associated patient infection was very rare, but it is now known to be much higher based on evidence of multiple outbreaks.1, 2, 3

A recent, very large, epide-

miolocal study of U.S. based ambulatory procedures show the risk ranges between common and uncommon (based on World Health Organization defi nitions). In this study, upper gastroscopy, cystoscopy and bronchoscopy procedures represented the highest risk.4

This study also showed that

when an endoscopy-related infection oc- curs, the outcome for the patient is poor often requiring multi-day hospital stays and a negative impact on quality of life. Flexible endoscopes are highly contami- nated during procedures — much more so than typical surgical instruments and the complex design can make them dif- fi cult to effectively and repeatedly safely reprocess.5,6

Documented infections have

occurred with every type of endoscope and in general, current clinical practices are often far below existing recommended professional standards.7,8


endoscopes Does current evidence support a change? by Janet Prust, Director, Standards and Scientifi c Affairs/ 3M Medical Solutions Division

Because fl exible endoscopes are classi-

fi ed as medical devices and regulated by the Food and Drug Administration (FDA), endoscope manufacturers are required to develop and test or validate reprocessing instructions including the requirements for cleaning, high-level disinfection and/ or sterilization processes. Users must rely on the manufacturers to develop methods that can be performed in the health care facility. FDA can and has required fl exible endoscope manufacturers to revalidate reprocessing instructions and has more recently implemented post-market surveil- lance requirements to ensure the endoscope manufacturer’s instructions for use can be effectively performed in healthcare facilities.9

Evidence Beginning in 2013, alarming outbreaks with multi-drug resistant organisms (MDROs) were associated with duodenoscopes, and some of the outbreaks were widely publi- cized. While much of the focus was on duo- denoscopes, there have been documented transmission and continuing reports of patient ready endoscope contamination for other endoscope types as well. An increas- ing number of publications, safety alerts, updated reprocessing guidelines, patient injury reports, and continuing calls to im- prove the process have been issued. 2, 10, 11, 12 Several of the facilities with MDRO and duodenoscope-related outbreaks changed their process and moved from high-level disinfection to terminal sterilization with ethylene oxide. This change was in addi- tion to assessing the complete reprocessing practice and ensuring it met both the manu- facturers’ IFUs and recognized guidelines. The move to ethylene oxide was attributed to halting the endoscope-related transmis- sion.13, 14, 15, 16, 17, 18

issued updated guidelines related to repro- cessing fl exible endoscopes.11, 12, 18, 19

All the relevant U.S. organizations have While

the guidelines vary on the specifi c recom- mendations, all focus on improving train- ing and competency assessments, more thorough cleaning procedures and using or

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