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: Patient Notification

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

Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late, a March study has found, raising questions about…

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 | Patient notification of an infection control breach is also discussed |

November 26, 2024 Lawrence F Muscarella PhD

FDA data suggest that patient exposures to inadequately cleaned GI endoscopes potentially contaminated with infectious materials, while not assuring infection, may be under-recognized safety concern.

Carbapenem-Resistant Enterobacteriaceae (CRE) Colonoscopes Device Contamination Duodenoscopes Enteric Bacteria Olympus TJF-Q180V Patient Notification Transparency University of North Carolina - Chapel Hill

At Least 40% of Disinfected Endoscopes, Possibly Colonoscopes, Remained Contaminated, Emails Reveal The endoscopes tested "positive" for contamination with concerning bacteria.

July 28, 2016 Lawrence F Muscarella PhD

July 28, 2016 — A manufacturer decided not to warn U.S. hospitals in February 2013 about a certain complex endoscope that reports indicated was unreasonably prone to infecting patients with…

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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