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: Automated Endoscope Reprocessors

Automated Endoscope Reprocessors Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Postmarket surveillance studies

FDA Orders Endoscope Manufacturers to Perform Safety Studies

October 6, 2015 Lawrence F Muscarella PhD

October 6, 2015 — Yesterday the U.S. Food and Drug Administration (FDA) ordered the three manufacturers of certain specialized medical endoscopes sold in the U.S. to perform “postmarket” surveillance studies.…

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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