The US Food and Drug Administration (FDA) has cleared for marketing the first fully disposable duodenoscope, the EXALT Model D Single-Use Duodenoscope, manufactured by Boston Scientific Corporation.1
Duodenoscopes are used in more than 500,000 procedures each year in the United States and contain complicated moving parts and channels that have been notoriously difficult to clean, sterilize, and decontaminate. Reusable duodenoscopes have been linked with several outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) infections following endoscopic retrograde cholangiopancreatography (ERCP), which led the FDA to issue a number of safety protocols in August 2019.2
“The availability of a fully disposable duodenoscope represents a major step forward for improving the safety of these devices, ,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a press release. “Unlike reusable duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be [cleaned and sterilized], eliminating the risk of potential infection due to ineffective reprocessing.”
This the second recent approval by the FDA to improve the safety of duodenoscopes. In November 2019, the FDA approved the first duodenoscope with a sterile, disposable elevator piece designed to reduce the number of parts that needed to be cleaned and disinfected between uses.3 The Pentax Medical Video ED34-i10T2 model “reduces reprocessing obstacles, [thus] the risk for serious infection will potentially be averted,” according to a press release from the FDA.
Although the disposable elevator reduces the number of parts that need to be cleaned, it is still very cumbersome to disinfect these small components. The EXALT Model D Single-Use Duodenoscope is intended for use on a single patient, therefore removing the potential risks associated with ineffective reprocessing, noted the agency.
Risks of using the EXALT Model D Single-Use Duodenoscope include the potential for injuries including burns, electric shock, perforation, infection, and bleeding, noted the agency.
“Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices,” concluded Dr Shuren.
1. US Food and Drug Administration. FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing [press release]. https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective. December 13, 2019. Accessed December 18, 2019.
2. US Food and Drug Administration. The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication [news release]. https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication. Updated August 29, 2019. Accessed December 18, 2019.
3. US Food and Drug Administration. 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. November 15, 2019. Accessed December 18, 2019.