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
by Kara Nadeau Della Vecchia In recent years the healthcare industry has turned a critical eye toward immediate-use steam sterilization (IUSS) – formerly known as flash sterilization – because its use in inappropriate clinical situations can increase the risk of healthcare-associated infections (HAIs). But the use of IUSS is still . . . Read more
The Association for the Advancement of Medical Instrumentation (AAMI) presents action steps that sterile processing departments can take to improve the quality of medical device and surgical instrument reprocessing: 1. The basics: Cleaning and disinfection/sterilization of reusable devices are separate, equally important processes and must be performed before each patient . . . 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