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: Food and Drug Administration

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. …

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”

Apr 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…

FDA Updates

Apr 8, 2015 Lawrence F Muscarella PhD

The following lists most of the FDA’s recently issued updates, safety communications and alerts discussing the manual and automated cleaning and disinfection of side-viewing duodenoscopes (or, ERCP endoscopes). Recommendations provided…

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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