FDA Updates
The following lists most of the FDA’s recently issued updates, safety communications and alerts discussing the manual and automated cleaning and disinfection of side-viewing duodenoscopes (or, ERCP endoscopes). Recommendations provided…
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
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 — 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…