FDA took several actions this week to address the ongoing problem of contamination on difficult-to-clean devices used for endoscopic procedures.
In April FDA reported that postmarket surveillance studies indicated higher-than-expected levels of contamination on duodenoscopes after reprocessing. Now, FDA is recommending that healthcare facilities either use fully disposable duodenoscopes or ones with disposable endcaps when they become available. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps, the agency said.
Duodenoscopes are the flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) to diagnose and treat problems in the pancreas and bile ducts.
“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all healthcare facilities due to cost and market availability,” said Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “This is why we’re communicating with healthcare facilities now—so they can begin developing a transition plan to replace conventional duodenoscopes—and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models."
Shuren said FDA is also encouraging the manufacturers of these duodenoscope models to assist healthcare facilities with their transition plans.
"While the risk of infection from inadequate reprocessing is relatively low, we are taking action because of continuing elevated levels of contamination in duodenoscopes," Shuren said.
FDA also ordered new postmarket surveillance studies on duodenoscopes with disposable endcaps in order to verify that these new designs do reduce contamination. The agency also requested that real-world contamination rates be included in duodenoscope labeling. And finally, FDA said it has issued letters to manufacturers of certain test strips that have not been reviewed by FDA but claim to assess duodenoscope cleanliness.
Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end.
Postmarket human factors studies suggest that users frequently had difficulty understanding and following manufacturers' reprocessing instructions and were not able to successfully complete reprocessing, which may leave the devices contaminated. FDA said it will continue to work with manufacturers to conduct additional testing and revise reprocessing instruction manuals, but the best path to reducing the risk of disease transmission by these devices is through innovative designs, such as those with disposable components, that make reprocessing easier, more effective, or unnecessary.
FDA has cleared two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T. Additionally, other firms have publicly announced plans to develop fully disposable duodenoscopes. During a quarterly earnings call earlier this year, Boston Scientific CEO Mike Mohoney said the company
During Boston Scientific's first-quarter earnings call, CEO Mike Mahoney said the company is on track to launch its Exalt-D single-use duodenoscope.
"The Exalt model D single-use scope has been designed to address this exact issue by eliminating scope disinfection challenges completely," Mahoney said. "This platform represents a significant opportunity in 2020 and beyond."
Pentax Medical is also attacking the issue from a different angle by promoting a new hygiene solution designed to enhance patient safety in endoscopy. Last year Pentax acquired a controlling interest in Paris, France-based PlasmaBiotics, a company that makes devices for drying and storing endoscopes.
Pentax touted the PlasmaTyphoon at the European Society of Gastrointestinal Endoscopy (ESGE) Days in Prague in April. The device is designed to minimize the risk of bacterial contamination through a highly effective drying mechanism and active storing of the endoscopes with plasma, via the PlasmaBag, for up to 31 days.
"The focus is usually on the cleaning of endoscopes, but if you do not dry properly at the end of the whole procedure, then you make all your work for nothing," Ulrike Beilenhoff, former president of the European Society of Gastroenterology and Endoscopy Nurses and Associates, said during a video Pentax Medical provided to journalists following ESGE Days.