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: Medical Device Reports (MDRs)

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…

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…

Automated Endoscope Reprocessors Carbapenem-Resistant Enterobacteriaceae (CRE) Department of Veterans Affairs Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Medical Device Reports (MDRs) Multidrug Resistant Strains Olympus TJF-Q180V Veterans Health Administration

FDA Warns Three Endoscope Manufacturers for Safety Violations Following Deadly ‘Superbug’ Outbreaks

August 18, 2015 Lawrence F Muscarella PhD

August 18, 2015 — The FDA has “warned” the three manufacturers of medical endoscopes used in the U.S. for failing to comply with federally mandated regulations. Last week, the FDA…

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