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FDA Safety Communication TJF-Q180V

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

URGENT DEVICE ACTION TJF-Q180V

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

FDA MedWatch – ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication – FUJIFILM Medical Systems Validates Revised Reprocessing Instructions

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

Ban the Handshake in Health Care

Hand hygiene compliance is the key to infection prevention efforts, but the hand-to-hand transfer of infectious bacteria remains a common public health hazard. Is it time to ban handshakes in healthcare settings? In an editorial published online in JAMA earlier this month, 3 clinicians from the David Geffen School of . . . Read more