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: Adverse-Event-Reports

Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT 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

Aug 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.

Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

Jan 6, 2023 Lawrence F Muscarella PhD

This article presents an FDA report filed in November — publicized now for the first time — that links gastroscopes to 3 patients testing positive for a “rare strain” of…

Adverse Event Reports Colonoscopes Duodenoscopes Endoscope Reprocessing Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

Sep 27, 2022 Lawrence F Muscarella PhD

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.

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Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT 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

Aug 2, 2023 Lawrence F Muscarella PhD
Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

Jan 6, 2023 Lawrence F Muscarella PhD
Adverse Event Reports Colonoscopes Duodenoscopes Endoscope Reprocessing Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract

Sep 27, 2022 Lawrence F Muscarella PhD
Alcohol Rinsing Endoscope Drying Endoscope Reprocessing

Flushing Endoscopes With 70% Alcohol to Facilitate Channel Drying

Feb 22, 2022 Lawrence F Muscarella PhD