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…
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…
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Food and Drug Administration
FUJIFILM
Olympus
Pentax
CNN: “Deadly superbug-related scopes sold without FDA approval”
CNN: “FDA official says Olympus never got permission to sell its endoscope” — click here. CNN and other news outlets including The Los Angeles Times are reporting that the type…