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

522 Order Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes Food Drug and Cosmetic Act FUJIFILM MCR-1 gene Medical Device Reports (MDRs) Olympus Pentax Postmarket surveillance studies Warning letters (FDA)

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

Mar 15, 2018 Lawrence F Muscarella PhD

March 15, 2018 (1:14 pm)  — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in…

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.”…

Automated Endoscope Reprocessors Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Postmarket surveillance studies

FDA Orders Endoscope Manufacturers to Perform Safety Studies

Oct 6, 2015 Lawrence F Muscarella PhD

October 6, 2015 — Yesterday the U.S. Food and Drug Administration (FDA) ordered the three manufacturers of certain specialized medical endoscopes sold in the U.S. to perform “postmarket” surveillance studies. …

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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
Adverse Event Reports Bronchoscopes Colonoscopes Cystoscopes Duodenoscopes ENT Endoscopes Flexible "ENT" Laryngoscopes Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Single-Use Disposable Devices Urological Endoscopes

Contamination of Flexible Endoscopes and Associated Infections:

Jan 28, 2022 Lawrence F Muscarella PhD