FDA sets meeting to discuss EO sterilization
Editor's Note The Food & Drug Administration (FDA) announced September 4 that it will hold a Medical Devices Advisory Committee Meeting in November to discuss ethylene oxide (EO) sterilization of medical devices, including methods to reduce EO emissions. The committee also will provide recommendations on reducing infection risks from reprocessed…
FDA recommends transition to duodenoscopes with disposable components
Editor's Note The Food & Drug Administration (FDA) on August 29 issued a News Release recommending that healthcare facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce the risk of patient infection. The FDA also announced additional actions they have taken to help ensure the safety of…
FDA: Class I recall of Vyaire Medical enFlow fluid warming disposable cartridge
Editor's Note The Food & Drug Administration (FDA) on August 21 identified Medline Industries’ recall of Centurion Medical Products’ Primary Warmer Pack containing the Vyaire Medical enFlow fluid warming system disposable cartridge as Class I, the most serious. The recall was initiated because the cartridge may elute aluminum into infused…
FDA: Class I recall of Edwards Lifesciences SAPIEN 3 Ultra Delivery System
Editor's Note The Food and Drug Administration on August 22 identified the recall by Edwards Lifesciences of all lots of its SAPIEN 3 Ultra Delivery System as Class I, the most serious. The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. The recall was initiated…
FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library
Editor's Note The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious. The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of…
FDA: Class I recall of Teleflex/Sheridan Endotracheal Tubes
Editor's Note The Food & Drug Administration (FDA) on August 2 identified the recall by Centurion Medical Products of its Airway Kit containing Teleflex/Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the potential for the tube connector to dislodge from the endotracheal tube,…
NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes
Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…
FDA: Class I recall of Ellipse Implantable Cardioverter Defibrillators
Editor's Note The Food & Drug Administration on August 5 identified the recall by Abbott (formerly St Jude Medical Inc) of its Ellipse Implantable Cardioverter Defibrillators as Class I, the most serious. The recall was initiated because electrical failures have been identified that are due to a faulty manufacturing process…
FDA issues final guidance for drug-device combo products
Editor's Note The Food & Drug Administration (FDA) on July 22 issued a final guidance for makers of products that combine devices and drugs or biologics. The guidance clarifies how manufacturers should comply with recordkeeping requirements and how they should submit safety reports and avoid duplication.
FDA: Class I recall of Getinge’s Maquet/Datascope intra-aortic balloon pumps
Editor's Note The Food & Drug Administration on July 23 identified the recall by Getinge of its Maquet/Datascope intra-aortic balloon pumps (IABPs) as Class I, the most serious. Recall of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS 100/100i IABPs was initiated because of reports of the IABP batteries failing…
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