FDA Safety Communication Addresses Importance of Following Duodenoscope Reprocessing Instructions

Published: 04/12/2019

  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care

The U.S. Food and Drug Administration (FDA) is issuing this communication to update the Safety Communication issued December 2018 regarding results from postmarket surveillance studies mandated under Section 522 of the Federal Food, Drug, and Cosmetic Act (“522 studies”) for duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography procedures (ERCP). The FDA is also reminding facilities about the importance of strictly adhering to the manufacturer’s reprocessing and maintenance instr

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