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: FUJIFILM

522 Order Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes Food Drug and Cosmetic Act FUJIFILM MCR-1 gene Medical Device Reports (MDRs) Olympus Pentax Postmarket surveillance studies Warning letters (FDA)

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

March 15, 2018 Lawrence F Muscarella PhD

March 15, 2018 (1:14 pm) — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in…

Advocate Lutheran General Hospital Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) FUJIFILM Lawsuits Medical Device Reports (MDRs) Olympus Pentax Superbugs

Wrongful Death Suit Blames a Chicago-Area Hospital and Endoscope Manufacturer for a Fatal ‘Superbug’ Infection

September 2, 2015 Lawrence F Muscarella PhD

September 2, 2015 — Lawyers representing the family of an 82-year-old woman who died from a ‘superbug’ infection linked to a contaminated medical endoscope have filed a wrongful death lawsuit…

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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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January 6, 2023 Lawrence F Muscarella PhD