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: Colistin-Resistant Bacteria

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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