Category: Risk Assessment

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.

A ‘Trickle-Down Effect’: The Potential Impact of the FDA’s Warning About Endoscope Safety on Automated Endoscope Reprocessors

August 19, 2015 — Late last week the FDA “warned” FujiFilm, Olympus and Pentax — the manufacturers of virtually every gastrointestinal endoscope used in the U.S. — for failing to comply…

Lessons Taught by a Recent “Superbug” Outbreak: Could ‘Ex Post Facto’ Notification be Warranted?

April 21, 2014 — Advocate Lutheran General Hospital (Park Ridge, IL) in 2013 linked multiple patient infections and colonizations of carbapenem-resistant Enterobacteriaceae, or “CRE,” to contaminated gastrointestinal (GI) endoscopes. This…