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FDA Recommends Transition to Duodenoscopes With Disposable Components

U.S. Food and Drug Administration
August 29, 2019

Today, the U.S. Food and Drug Administration is recommending that duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse (reprocessing) and persistent high levels of contamination, the agency is recommending moving away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps—or to fully disposable duodenoscopes 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.