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)

510(k) Clearances Carbapenem-Resistant Enterobacteriaceae (CRE) Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Ted Lieu USA Today

USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”

April 21, 2015 Lawrence F Muscarella PhD

Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might…

Antibiotic-Resistant Bacteria Carbapenem-Resistant Enterobacteriaceae (CRE) E. coli Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) FUJIFILM Gastrointestinal Endoscopy GI Endoscopes Infection Prevention Medical Device Reports (MDRs) Olympus Outbreak Investigations Patient Notification Patty Murray (U.S. Senator) Pentax The Seattle Times Virginia Mason Medical Center

THE SEATTLE TIMES: Senator Patty Murray urges FDA to Act to Prevent “Superbug” Infections Following GI Endoscopy

February 4, 2015 Lawrence F Muscarella PhD

The February 4, 2015, edition of The Seattle Times newspaper publishes the article: “After Virginia Mason superbug, Patty Murray urges FDA action” The article’s sub-title states: “U.S. Sen. Patty Murray…

Antibiotic-Resistant Bacteria Automated Endoscope Reprocessors Carbapenem-Resistant Enterobacteriaceae (CRE) Carbapenems Custom Ultrasonics E. coli Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) FUJIFILM Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae Medical Device Reports (MDRs) Medical Errors NDM-producing E. coli Olympus Pentax Superbugs

Important Lessons Taught by Recent “Superbug” Outbreaks Linked to GI Endoscopes

January 15, 2015 Lawrence F Muscarella PhD

January 15, 2015 — More than a dozen outbreaks of “CRE” and their related superbugs have been recently linked to contaminated gastrointestinal (GI) endoscopes, several in the U.S. just since…

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

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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

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

January 6, 2023 Lawrence F Muscarella PhD