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: Manufacturers

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…

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