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: Device Recalls

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.

Oct 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 a…

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.

Sep 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 a “new feature.”…

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.

Mar 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 have learned. The…

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Jan 28, 2022 Lawrence F Muscarella PhD