Discussions in Infection Control

An independent site by Lawrence F Muscarella PhD -- a national authority on the causes and prevention of healthcare-associated infections and related errors.

Category: Form 483

Automated Endoscope Reprocessors Carbapenem-Resistant Enterobacteriaceae (CRE) Custom Ultrasonics Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Form 483 Medical Device Reports (MDRs) Olympus TJF-Q180V Risk Assessment Ronald Reagan Medical Center (UCLA)

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

August 21, 2015 Lawrence F Muscarella PhD

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…

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Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Escherichia coli Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

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