Top 5 most challenging requirements for 2021 | The Joint Commission | FDA
Top 5 most challenging requirements for 2021 | The Joint Commission
Top 5 most challenging requirements for 2021 | The Joint Commission
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication | FDA
Duodenoscope Model TJF-Q180V by Olympus: UPDATED FDA Safety Communication – New Reprocessing Instructions Validated UPDATED 01/15/2016. The Agency is redistributing the March 26, 2015 Safety Communication with updated status information about the Agency’s 510(k) clearance decision and Olympus Corporation of the America’s Customer Notification. On March 4, 2015, the FDA . . . Read more
OLYMPUS January 15, 2016 URGENT MEDICAL DEVICE REMOVAL and CORRECTIVE ACTION: ELEVATOR MECHANISM REPLACEMENT, UPDATED OPERATION MANUAL, AND NEW REPROCESSING INSTRUCTIONS FOR THE OLYMPUS TJF-Q180V DUODENOSCOPE ATIENTION: Endoscopy Department, Infection Control and Reprocessing Units Re: OLYMPUS TJF-Q180V Duodenoscope All Serial Numbers manufactured prior to January 2016 Dear Health Care Professional: Olympus . . . Read more
AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing ISSUE: FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the . . . Read more
AUDIENCE: Risk Manager, Pulmonology, Otolaryngology, Cardiothoracic Surgery ISSUE: The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them. . . . Read more