Medical Device Safety and Recalls: Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

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

Title: Medical Device Safety and Recalls: Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

The FDA is issuing a safety communication to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of duodenoscopes, used during a procedure known as Endoscopic Retrograde Cholangiopancreatography (ERCP) may impede effective reprocessing. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. The FDA’s safety communication contains recommendations for health care professionals, reprocessing facilities and patients, to help reduce the risk of infection.

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