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: Data Validation

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…

Antibiotic-Resistant Bacteria Best Practices Bundles catheter-associated urinary tract infections Central Line-Associated Bloodstream Infections Central-Line Venous Catheters Checklists Data Validation Healthcare Quality, Safety Healthcare-Acquired Infections Infection Prevention Interventions Patient Notification Published Infection Rates

NJ.com: “Hospitals get a mixed report card for preventing dangerous infections”

February 9, 2015 Lawrence F Muscarella PhD

NJ.com (January 16, 2015) “Hospitals get a mixed report card for preventing dangerous infections.” NOTABLE QUOTES Centers for Disease Control and Prevention (CDC): Eliminating hospital infections is a “top priority.”…

American Society of Gastrointestinal Endoscopy Antibiotic-Resistant Bacteria Carbapenem-Resistant Enterobacteriaceae (CRE) Carbapenems Centers for Disease Control and Prevention Data Validation Device Contamination Device Recalls E. coli Endoscope Reprocessing Endoscope Sampling Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Esophagogastroduodenoscopy (EGD) Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Healthcare Quality, Safety Infection Prevention Olympus Patient Notification Root Causes Analysis The Seattle Times Transparency USA Today

THE SEATTLE TIMES: “Undisclosed superbug sickened dozens at Virginia Mason”

January 22, 2015 Lawrence F Muscarella PhD

The Seattle Times: “Undisclosed superbug sickened dozens at Virginia Mason” (January 22, 2015) An outbreak of multidrug-resistant superbugs spread by contaminated endoscopes infected at least 35 patients at Virginia Mason…

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