The U.S. FDA has issued a safety communication providing updated recommendations for bronchoscope reprocessing and other new information about bronchoscope medical device adverse event reports.
This is a supplement to the 2015 safety communication on reprocessed flexible bronchoscopes.
The FDA is reminding healthcare facilities and staff responsible for reprocessing bronchoscopes and their accessories about the importance of carefully following the manufacturer’s reprocessing instructions, in addition to FDA-recommended practices.
The FDA continues to recommend that healthcare providers discuss the benefits and risks associated with procedures involving reprocessed bronchoscopes with patients, and that they discuss signs of a potential infection after a bronchoscopy procedure and when patients should seek medical attention.
The FDA is now also providing the following new recommendations:
- Consider using a single-use bronchoscope in situations where there is increased risk of spreading infection (for example, multidrug resistant microorganisms, immunocompromised patients, or patients with prion disease) or when there is no support for immediate reprocessing of the bronchoscope.
- When treating patients with COVID-19, refer to recent recommendations from the American Association for Bronchology & Interventional Pulmonology (AABIP).
For more information, visit FDA.