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.

Month: March 2015

Carbapenem-Resistant Enterobacteriaceae (CRE) Carbapenems Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Gastrointestinal Endoscopy GI Endoscopes Olympus Olympus TJF-Q180V Ted Lieu

Congressman Lieu Asks Questions of Endoscope Manufacturers in the Wake of Several Deadly “Superbug” Outbreaks

March 30, 2015 Lawrence F Muscarella PhD

U.S. Rep. Ted Lieu (D-Calif.) has written letters to the Olympus Corporation of the Americas (Center Valley, PA) and to Pentax Medical (Montvale, NJ) asking a number of questions in…

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…

Carbapenem-Resistant Enterobacteriaceae (CRE) Design Control Device Contamination Disease Transmission Dr. Drew Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Superbugs

HLN-TV NEWS: “Dr. Drew responds to ‘superbug’ health scare” — Dr. Muscarella’s Reply

March 10, 2015 Lawrence F Muscarella PhD

Dr. Muscarella’s following comments and perspectives are in reply to HLN-TV’s recent article: Dr. Drew responds to ‘superbug’ health scare | HLNtv.com (March 9, 2015) HLN-TV (a national television network)…

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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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