The FDA’s Safety Communication Update for Reprocessing Bronchoscopes

09/20/21 • 18 min

The U.S. Food and Drug Administration recently updated a safety communication on reprocessing flexible bronchoscopes. In that update, the FDA recommends, among other things, that healthcare providers consider using single-use bronchoscopes when there is increased risk of spreading infection and when treating COVID-19 patients. To break down this announcement and what it means, we talked to Dr. Hudson Garrett, an infection prevention and control expert who is sought after for strategic insights and advice on infectious disease, epidemiology, patient safety and medical affairs.

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Infection Control Risks and Endoscopy

What are the challenges, and potential missteps, when it comes to reprocessing bronchoscopes, GI endoscopes and ureteroscopes? How have guidelines and standards evolved? And how has COVID-19 flipped the script when it comes to pursuing evidence-based strategies to eliminate infections related to endoscopes? We explore these questions and more with Dr. Hudson Garrett, CEO of Community Health Associates LLC in Atlanta and co-founder of the nonprofit Infection Prevention Institute.

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FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

The U.S. Food and Drug Administration is investigating “numerous” medical device reports (MDRs) describing patient infections and other possible contamination issues possibly associated with reprocessed urological endoscopes. Dr. Larry Muscarella, an independent safety expert who advises hospitals, manufacturers and the public about medical device safety and infection prevention, talks about the letter to healthcare providers from the FDA. He also breaks down what it means, what surprised him about this latest course of action surrounding endoscopes and reprocessing, and what to watch for next.