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: FDA-Warning-Letter

Adulterated Devices Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT MAJ-2315 Misbranded Devices Olympus TJF-Q190V Single-Use Endcap with Elevator Warning letters (FDA)

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

August 2, 2023 Lawrence F Muscarella PhD

Updated guidance is provided to reduce the risks of mucosal injuries and the endcap becoming detached and falling off inside the patient when using a duodenoscope with a single-use endcap.

Automated Endoscope Reprocessors Carbapenem-Resistant Enterobacteriaceae (CRE) Department of Veterans Affairs Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Medical Device Reports (MDRs) Multidrug Resistant Strains Olympus TJF-Q180V Veterans Health Administration

FDA Warns Three Endoscope Manufacturers for Safety Violations Following Deadly ‘Superbug’ Outbreaks

August 18, 2015 Lawrence F Muscarella PhD

August 18, 2015 — The FDA has “warned” the three manufacturers of medical endoscopes used in the U.S. for failing to comply with federally mandated regulations. Last week, the FDA…

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Adulterated Devices Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT MAJ-2315 Misbranded Devices Olympus TJF-Q190V Single-Use Endcap with Elevator Warning letters (FDA)

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

August 2, 2023 Lawrence F Muscarella PhD
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

Gastroscopes Have Been Linked to A Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

January 6, 2023 Lawrence F Muscarella PhD