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 and Drug Administration

Carbapenem-Resistant Enterobacteriaceae (CRE) Device Recalls Endoscope Reprocessing Endoscope Sampling Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Food and Drug Administration Klebsiella pneumoniae Outbreak Investigations Superbugs University of Pittsburgh Medical Center

Risk of “Superbug” Outbreaks Linked to Two Types of Gastrointestinal Endoscopes: Pittsburgh (PA), 2012

January 21, 2015 Lawrence F Muscarella PhD

January 21, 2015 — The University of Pittsburgh Medical Center — also known as “UPMC” — linked a bacterial “superbug” outbreak in 2012 to the inadequate cleaning and disinfection, or…

510(k) Clearances Automated Endoscope Reprocessors Biological Indicators De Novo Classifications Endoscope Reprocessing Food and Drug Administration Glutaraldehyde Liquid Chemical Sterilants Liquid Chemical Sterilization Spore Strip Tests Sterility Sterility Assurance Level Sterilization STERIS System 1 STERIS System 1E

The Use of Biological Indicators to Monitor Liquid Chemical Sterilants: The FDA’s Position, 2014

November 25, 2014 Lawrence F Muscarella PhD

November 25, 2014 — The proper use of “BIs” – or biological indicators – in the healthcare setting is crucial to assess the effectiveness of the sterilization process. Failure to…

Adulterated Devices Ambulatory Surgery Centers Aseptic Technique Association of periOperative Registered Nurses Automated Endoscope Reprocessors Biological Indicators Central Sterile Processing Chemical Indicators Design Control Device Recalls Endoscope Reprocessing Flash Sterilization Flash Sterilization Food and Drug Administration Immediate-Use Steam Sterilization Infection Prevention Instrument Drying Instrument Reprocessing Liquid Chemical Sterilization Low-Temperature Sterilization Misbranded Devices Monitoring Rinse Water Operating Rooms Product Labeling Steam Sterilization STERIS STERIS System 1 STERIS System 1E Water Filtration

The STERIS System 1E Liquid Chemical Sterilant Processing System: Looking Back and Forward

November 7, 2014 Lawrence F Muscarella PhD

July 1, 2015 — Almost four years ago, on April 5, 2010, the Food and Drug Administration (FDA) cleared the STERIS System 1E Liquid Chemical Sterilant Processing System, or “SS1E,”…

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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