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: Investigational Devices

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…

ABTOX Plazlyte System Adulterated Devices Automated Endoscope Reprocessors Biological Indicators Disease Transmission Endoscope Damage Food and Drug Administration Gastrointestinal Endoscopy Immediate-Use Steam Sterilization Infection Prevention Instrument Reprocessing Investigational Devices Liquid Chemical Sterilization Low-Temperature Sterilization Misbranded Devices Peracetic Acid Sleeping Dogs Sterilization STERIS STERIS System 1 STERIS System 1E

History of the STERIS System 1: A Detailed Review

January 9, 2013 Lawrence F Muscarella PhD

September 18, 2013 — This article discusses the history of the STERIS System 1 Liquid Chemical Processor and its de facto recall (by the Food and Drug Administration). Click here…

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Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Escherichia coli Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

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January 6, 2023 Lawrence F Muscarella PhD