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Celiac.com 04/20/2022 - The US Food and Drug Administration (FDA) is directing healthcare facilities and providers to transition to fully disposable duodenoscopes, and those with disposable components. The FDA made the announcement after an analysis of post-market surveillance studies supported the agency's concerns about the difficulty of fully cleaning fixed endcap duodenoscopes. Among other things, the agency noted that older reusable duodenoscope models had contamination rates as high as 6%, compared with just .5% for disposable models. The agency notes that disposable duodenoscopes and components reduce patient contamination risk "by half or more as compared to reusable, or fixed endcaps." The contamination concerns, coupled with the increasing availability of disposable duodenoscopes led the agency to update its April 2020 recommendations on the subject. Duodenoscopes are used in more than half a million medical procedures annually in the United States, and play an important part in evaluating and treating diseases and problems of the pancreas and bile ducts. While duodenoscope manufacturers no longer sell fixed endcap models in the United States, numerous healthcare facilities still use them. To decrease infections, the FDA now recommends that all fixed endcap models be replaced. The agency notes that some companies have programs in place to upgrade their old models with a disposable component at no cost. The FDA has approved two fully disposable duodenoscope models, along with five that use disposable components. Only four of the disposable components are currently available in the U.S. FDA-approved fully disposable duodenoscopes include: Ambu Innovation GmbH, Duodenoscope model aScope Duodeno Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope FDA-approved disposable duodenoscope components include: Fujifilm Corporation, Duodenoscope model ED-580XT Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V Pentax Medical, Duodenoscope model ED34-i10T2 Pentax Medical, Duodenoscope model ED32-i10 Read more at Medscape.com

Celiac.com 09/10/2019 - The US Food and Drug Administration (FDA) is recommending that manufacturers of duodenoscopes, along with health care facilities, switch to duodenoscopes with disposable parts to help reduce the risk of patient infection. Post-market surveillance studies ordered by the FDA reveal that contamination rates for reusable duodenoscopes remain unacceptably high after reprocessing, with avoidable deaths and infections still occurring. As a result, the agency is now recommending the elimination of duodenoscopes with fixed endcaps in favor of those with either disposable components, including disposable endcaps, or fully disposable duodenoscopes as they become available. By simplifying or eliminating the need for reprocessing, disposable duodenoscopes may reduce between-patient contamination associated with reusable, or fixed endcaps, says an agency communication. Duodenoscope Transition Will Be Gradual The FDA is urging that the transition to disposable duodenoscopes, or those with disposable parts, be undertaken gradually, as full-market withdrawal of conventional, fixed endcap duodenoscopes is unfeasible, and could trigger a shortage. "We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the release. Though a slow transition may seem less optimal, "the FDA believes, at this time, the continued availability of these devices is in the best interest of the public health," the agency said. The FDA is working with manufacturers to increase the supply of disposable cap duodenoscopes and develop new device designs that will further reduce or eliminate the risk of patient infection, Shuren said. Specifically, the FDA is recommending healthcare facilities transition away from fixed endcap models, including Olympus Corporation's TJF-Q160, TJF-Q180V, PJF-160, and JF-140F; Fujifilm Medical Systems USA's ED-530XT; and Pentax Medical's ED-3490TK. Read more at Medscape Medical News