FDA Safety Communication – Supplemental Measures to Enhance Duodenoscope Reprocessing

The U.S. Food and Drug Administration (FDA) is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. 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. The supplemental measures Includes all Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes (side-viewing duodenoscopes).

The FDA recognizes that not all health care facilities can implement one or more of these measures, which require specific resources, training, and expertise. Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.