Guest Commentary: Single Use Duodenoscopes – Niche or Necessity?
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In this guest commentary, Tyler M. Berzin, MD, co-director of GI Endoscopy at Beth Israel Deaconess Medical Center, and Mohammad Bilal, MD, an advanced endoscopy fellow at Beth Israel Deaconess Medical Center, discuss developments surrounding duodenoscope contamination and the emergence of single use duodenoscopes.
Duodenoscope-associated infections were first flagged by the CDC in 2013. Despite users following manufacturer disinfection protocols, duodenoscope-related infection with multi-drug resistant bacteria were reported at several centers. In 2015, the FDA issued its first safety communication on the topic and ordered manufacturers to update their reprocessing protocols and conduct post marketing surveillance. Estimates of duodenoscope contamination rates after reprocessing have varied quite significantly, depending on testing methods and definitions. In any case, between 2015 and July 2019 the FDA received reports of 1,115 duodenoscope incidents of patient infection, exposure, or device contamination, and 79 associated deaths.
The duodenoscope is unique in construction with a distal endcap concealing a moving elevator, which is essential for device manipulation during endoscopic retrograde cholangiopancreatography (ERCP). The elevator and distal endcap make cleaning more difficult and can trap bacteria and debris. Despite implementation of more rigorous reprocessing, risk for contamination remains, leading the FDA to recommend transitioning away from fixed endcap duodenoscopes.
The FDA approved two duodenoscopes with disposable endcaps to facilitate reprocessing in 2017 and 2019 (Pentax Medical ED34-i10T and Fujifilm Corporation ED-580XT). More recently, a duodenoscope with a disposable elevator component was approved in November 2019 (Pentax Medical ED34-i10T2).
The Boston Scientific EXALT Model D is the first fully disposable, single use duodenoscope approved in the United States. In a multicenter case series of 60 ERCPs using the EXALT, performed from April to May 2019 by seven expert endoscopists, the ERCP completion rate was 96.7% (58/60) with two patients requiring crossover to a reusable duodenoscope. The median overall operator satisfaction rate for the device was 9 out of 10.
Over 660,000 ERCPs are performed annually in the United States and a transition to disposable duodenoscopes requires careful consideration. It will not eliminate all ERCP-related infections, as the risk for endogenous infections remain. The cost of a single use device is a major issue and Boston Scientific has not released price structures. A recent analysis demonstrated that a single use duodenoscope may be most cost-effective for low-volume centers and/or in the setting of a high baseline infection rate. However, for high-volume centers and/or in the setting of a very low baseline infection rate, an expensive single use duodenoscope might increase per-procedure cost dramatically. In addition to cost and safety considerations, some endoscopy units are finding it burdensome to keep up with the ever-changing, and sometimes seemingly contradictory, recommendations regarding duodenoscope disinfection from manufacturers, various societies, and federal agencies.
The push-pull between cost, safety and overall patient benefit is familiar territory in every field of medicine, and the recent duodenoscope saga forces us to address these issues head-on. What is clear is that ERCP remains a critically important and often life-saving intervention for countless patients, and legitimate progress is now being made to make this procedure even safer.
References:
Bang JY, et al. Gut. 2019;doi:10.1136/gutjnl-2019-318227.
FDA. FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection. https://www.fda.gov/news-events/press-announcements/fda-clears-first-duodenoscope-disposable-elevator-piece-reducing-number-parts-needing-disinfection. Accessed January 2, 2020.
FDA. Meeting of the General Hospital and Personal Use Devices Advisory Committee: Reducing the Risk of Infection from Reprocessed Duodenoscopes. https://www.fda.gov/media/132346/download. Accessed January 2, 2020.
FDA. The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication. Accessed January 2, 2020.
Muthusamy V, et al. Clin Gastroenterol Hepatol. 2019;doi:10.1016/j.cgh.2019.10.052.
Disclosures: Bilal reports no relevant financial disclosures. Berzin reports serving as a consultant for Boston Scientific, Fujifilm and Medtronic.
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