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: Medical Device Reports (MDRs)

Adverse Event Reports Bronchoscopes Colonoscopes Cystoscopes Duodenoscopes ENT Endoscopes Flexible "ENT" Laryngoscopes Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Olympus GF-UCT180 Pentax ED-3490TK Single-Use Disposable Devices Urological Endoscopes

Contamination of Flexible Endoscopes and Associated Infections | A Comprehensive Review and Analysis of FDA Adverse Event Reports

January 28, 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.

Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Colonoscopes Klebsiella pneumoniae MCR-1 gene Medical Device Reports (MDRs) Superbugs

A Colonoscope is Linked to Two Infections of the Nightmarish ‘CRE’ Superbug | Colonoscopy could now also be a risk factor for infection, in addition to ERCP and bronchoscopy.

January 10, 2019 Lawrence F Muscarella PhD

January 10, 2019 — Infections caused by a nightmarish superbug have been identified following exposure to a colonoscope, according to two related regulatory reports filed last month. On December 7th,…

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July 28, 2025 Lawrence F Muscarella PhD
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Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

May 13, 2025 Lawrence F Muscarella PhD
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Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

November 26, 2024 Lawrence F Muscarella PhD
Bronchoscopes Centers for Medicare and Medicaid Services (CMS) Endoscope Reprocessing Gastroscopes Infection Prevention Rebuttals TPT Medicare Payment Status

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

September 16, 2024 Lawrence F Muscarella PhD