January 30, 2019
ASGE reports on the FDA Safety Communication Regarding Interim Results of Duodenoscope Reprocessing Studies. The full article from ASGE follows below:
The US Food and Drug Administration (FDA) issued a Safety Communication providing interim results from the ongoing mandated postmarket surveillance studies (“522 study”) to inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after reprocessing. Facilities and staff that reprocess duodenoscopes are reminded of the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes.
The communication is intended for patients considering ERCP procedures as well as users and reprocessors of duodenoscopes. It summarizes reprocessing challenges; reports interim results from sampling and culturing studies; and makes recommendations for reprocessing and maintenance of duodenoscopes.
The communication also includes general advice for patients, updates readers on recent FDA activities, and reiterates the importance of prompt reporting of adverse events.
Additional background on this issue is provided in an introductory message from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health.