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: Misbranded Devices

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,”…

Bedside Cleaning Byrne Medical Central Sterile Processing Checklists Colonoscopes Colonoscopy Delayed Reprocessing Disease Transmission Disposable Irrigation Tubing Endoscopic Retrograde Cholangiopancreatography (ERCP) ERBE Esophagogastroduodenoscopy (EGD) Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Healthcare-Acquired Infections High-Level Disinfection HIV Infection Prevention Instrument Reprocessing Medical Errors Medivators Misbranded Devices Product Labeling Quality Assurance Quality System Regulation Reusable Biopsy Valves Risk Assessment Single-Use Disposable Devices Sterility Sterilization STERIS The Reuse of Single-Use Devices US Endoscopy Veterans Health Administration

“Disposable” Irrigation Tubing Used During Gastrointestinal Endoscopy A review of several marketed irrigating tubing kits.

August 15, 2013 Lawrence F Muscarella PhD

August 15, 2013 (updated: January 27, 2015) — This article by Dr. Muscarella is the 2nd in a series of three that discusses disposable tubing used for irrigation during gastrointestinal…

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