FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

Endoscopy Insights Podcast

FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

"If you're manually reprocessing — that is, cleaning and disinfecting a cystoscope — you want the quality of the water, you want to assure it does not have pseudomonas in it."

October 7, 2021
by Rob Terry



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.

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