Flexible Bronchoscopes and Updated Recommendations for Reprocessing – FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a supplement to the 2015 safety communication on reprocessed flexible bronchoscopes, reminding health care facilities to follow manufacturer instructions for reprocessing and device maintenance, and providing a new recommendation for health care providers on single-use bronchoscopes. The goal of the recommendations is to reduce potential infection transmission between patients. This communication also includes updated information on medical device adverse event reports.

This safety communication provides:

• Recommendations for patients and their caregivers.
• Recommendations for health care providers and facilities.
• Background on reprocessed flexible bronchoscopes and the FDA’s actions to address the issue.
• Instructions for reporting problems with bronchoscopes to the FDA.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education.