Medical Device Safety and Recalls: Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication

Today, the FDA issued a safety communication to further help reduce the risk of infection transmission associated with duodenoscope use.  In this communication, the FDA recommends health care facilities performing endoscopic retrograde cholangiopancreatography (ERCP) evaluate whether they have the expertise, training and resources to implement one or more supplemental measures discussed at May’s Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee meeting. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.

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