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.

Tag: FDA

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…

Antibiotic-Resistant Bacteria Bronchoscopes Carbapenem-Resistant Enterobacteriaceae (CRE) Cystoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Medwatch Superbugs

Additional Measures May Be Necessary to Stop ‘Superbug’ Outbreaks Following Endoscopy, Says the FDA

August 5, 2015 Lawrence F Muscarella PhD

The FDA issued a detailed MedWatch report yesterday informing health care facilities that some additional measures may be necessary to further reduce the risk of contaminated duodenoscopes transmitting CRE, or…

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Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

August 2, 2023 Lawrence F Muscarella PhD
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

Gastroscopes Have Been Linked to A Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

January 6, 2023 Lawrence F Muscarella PhD