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: 510(k) Clearances

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…

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…

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