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Study: FDA Data Shows Endoscope-Related Adverse Events Continue To Rise

 
• By Elizabeth Orr

A new review of adverse event data found reports tied to each of six endoscope categories rose significantly between 2014 and 2021. For gastroscopes, the rise was an eye-popping 8,630%.

Doctor holding endoscope before gastroscopy.
• Source: Doro Guzenda/Shutterstock

Adverse events involving reusable endoscopes continued to rise between 2014 and 2021 despite increased attention to the risk of infection posed by the devices, a review of the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database by device safety specialist Dr. Larry Muscarella found.

Muscarella, who is the president of LFM Healthcare Solutions, LLC, examined more than 15,000 adverse event reports across six endoscope categories: Bronchoscopes, colonoscopes, duodenoscopes, ear-nose-throat (“ENT”) endoscopes, gastroscopes and urological endoscopes. He used 2014 as a baseline because it was when the FDA first publicly linked a duodenoscope to infections and death

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