Study Probes FDA Adverse Event Data Tied to Flexible Endoscopes

Endoscopy Insights

A comprehensive review and analysis of adverse event reports involving flexible endoscopes filed with the U.S. Food and Drug Administration shows a marked increase for six types of scopes from 2014 through 2021. The analysis was undertaken by Dr. Larry Muscarella, president of LFM Healthcare Solutions and an independent safety expert who advises hospitals, manufacturers and the public about medical device safety and the causes of infections in healthcare facilities. Muscarella combed through the FDA’s so-called MAUDE database — the acronym stands for “Manufacturer and User Facility Device Experience” — and identified reports describing endoscope contamination.

In this conversation, we discuss why this kind of analysis is significant and what the findings reveal about the safe and effective cleaning of endoscopes.

Dr. Muscarella is an Ambu consultant.

Show notes:

Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports

Bio: Dr. Larry Muscarella

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