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)

Bronchoscopes Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin-Resistant Bacteria Device Recalls Duodenoscopes Endoscope Reprocessing Klebsiella pneumoniae Medical Device Reports (MDRs) Multidrug Resistant Strains O-ring Contamination Pseudomonas aeruginosa Superbugs

A Bronchoscope is Linked Again in the U.S. to an Outbreak of the Feared ‘CRE’ Superbug Is enough being done to improve safety? The recall of several bronchoscope models is also discussed.

October 1, 2018 Lawrence F Muscarella PhD

October 1, 2018 (updated: Oct. 5, 2018; edited: Oct. 8, 2020) — A bronchoscope’s use has been linked again to a “superbug” outbreak, this time involving “multiple patients,” according to…

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…

Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes MCR-1 gene Medical Device Reports (MDRs) Pentax ED-3490TK

A Duodenoscope Has Been Linked to ‘Probable Transmission’ of a Colistin-Resistant Superbug In January, the FDA had issued a safety alert reporting a "design issue" with the endoscope "that could increase the risk of patient infection."

December 8, 2017 Lawrence F Muscarella PhD

December 8, 2017 (2:46 pm) — A duodenoscope has been linked, possibly for the first time, to the “probable transmission” of a uniquely resistant type of superbug, I have learned.…

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January 6, 2023 Lawrence F Muscarella PhD