FDA Is Still Trying to Tackle the Dirty Duodenoscope Problem

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 manufactu...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news