FDA provides interim results of scope reprocessing study

The FDA is 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. Read the FDA safety communication.