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: Informed Consent

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…

CardioQuip Cincinnati Sub Zero Consent Decrees Data Validation Device Recalls Heater-Cooler Devices Informed Consent Legionella LivaNova (formerly Sorin Group) Maquet Medtronic Mycobacterium abscessus Mycobacterium chimaera Nontuberculous Mycobacteria ("NTM") Terumo

Infections Are Not Limited to the LivaNova’s Sorin 3T Heater-Cooler or to M. chimaera

January 18, 2017 Lawrence F Muscarella PhD

Synopsis: The infection risk associated with heater-cooler devices may be broader in scope and higher than federal health officials have publicly acknowledged. Not just one model, but most heater-cooler devices…

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

September 16, 2024 Lawrence F Muscarella PhD