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 Drug and Cosmetic Act

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

October 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”

April 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…

510(k) Clearances Adulterated Devices American Society of Gastrointestinal Endoscopy carbapenem Carbapenem-Resistant Enterobacteriaceae (CRE) Data Validation Design Control Device Recalls Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Food and Drug Administration Food Drug and Cosmetic Act Gastrointestinal Endoscopy GI Endoscopes Investigational Devices Misbranded Devices Olympus Olympus TJF-Q180V Risk Management

Considerations Not Addressed in the FDA’s Communication Discussing Olympus’ New Instructions for Reprocessing the TJF-Q180V Duodenoscope

March 27, 2015 Lawrence F Muscarella PhD

March 27, 2015 — On March 26, 2015, the FDA issued a safety communication: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes — click here. This Olympus safety communication…

You missed

Centers for Medicare and Medicaid Services (CMS) Endoscope-Associated Infections Healthcare Quality, Safety Healthcare-Acquired Infections Medicare's HAC Reduction Program

A Proposal to Include ‘Endoscope-Associated Infections’ as a Reportable Medicare Measure to Promote Patient Safety

July 28, 2025 Lawrence F Muscarella PhD
Adverse Event Reports Food and Drug Administration Food Drug and Cosmetic Act Informed Consent Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

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
Colonoscopy Endoscope Reprocessing Esophagogastroduodenoscopy (EGD) Hepatitis (B and C) Viruses HIV Patient Notification Vanderbilt Medical Center

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