Category: Risk Assessment

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

This article presents an FDA report filed in November — publicized now for the first time — that links gastroscopes to 3 patients testing positive for a “rare strain” of…

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…