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: Duodenoscopes

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.…

DEC Duodenoscope Duodenoscopes Duodenoscopes Olympus TJF-160F Pentax ED-3490TK Pentax ED34-i10T Pentax ED34-i10T2 Single-Use Disposable Devices

FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

September 25, 2017 Lawrence F Muscarella PhD

Sept. 25, 2017 (Monday; 11:47am) — The FDA announced last week that it has “cleared the first duodenoscope with a disposable distal cap” for use in U.S. hospitals, calling this…

510(k) Clearances Data Validation Duodenoscopes Echo-endoscopes Endoscopic Ultrasound (EUS) FUJIFILM ED-530XT Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae Olympus TJF-Q180V OXA-48-producing Patty Murray (U.S. Senator) Pentax ED-3490TK Soluscope

The Redesigned Olympus Duodenoscope Has Been Linked to a ‘Superbug’ Cluster The device's original design was recalled in January 2016 amid concerns about its safety.

March 22, 2017 Lawrence F Muscarella PhD

March 21, 2017 (9:58 pm ET) — A “corrected” duodenoscope design introduced last year by the manufacturer to replace a recalled device has been linked to a “superbug” cluster, I…

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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

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January 6, 2023 Lawrence F Muscarella PhD