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: American Society of Gastrointestinal Endoscopy

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…

American Society of Gastrointestinal Endoscopy Antibiotic-Resistant Bacteria Carbapenem-Resistant Enterobacteriaceae (CRE) Carbapenems Centers for Disease Control and Prevention Data Validation Device Contamination Device Recalls E. coli Endoscope Reprocessing Endoscope Sampling Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Esophagogastroduodenoscopy (EGD) Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Healthcare Quality, Safety Infection Prevention Olympus Patient Notification Root Causes Analysis The Seattle Times Transparency USA Today

THE SEATTLE TIMES: “Undisclosed superbug sickened dozens at Virginia Mason”

January 22, 2015 Lawrence F Muscarella PhD

The Seattle Times: “Undisclosed superbug sickened dozens at Virginia Mason” (January 22, 2015) An outbreak of multidrug-resistant superbugs spread by contaminated endoscopes infected at least 35 patients at Virginia Mason…

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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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