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

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…

Aseptic Technique Biological Indicators Carbapenem-Resistant Enterobacteriaceae (CRE) Critical Device Classifications Disease Transmission Endoscope Reprocessing Flexible "ENT" Laryngoscopes Food and Drug Administration High-Level Disinfection Hydraulic Fluid Infection Prevention Instrument Drying Intermediate-Level Disinfection Liquid Chemical Sterilization Low-Level Disinfection Noncritical Ophthalmic Instruments Patty Murray (U.S. Senator) Rigid Laryngoscopes Semicritical Devices Skin Electrodes (Reusable) Sterility Sterilization Toxic Anterior Segment Syndrome

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices

February 7, 2015 Lawrence F Muscarella PhD

February 5, 2015 — This article presents Dr. Muscarella’s response submitted in August 2011 to the federal Food and Drug Administration (FDA), in reply to the Agency’s request earlier that…

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