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…
CMS proposes giving Medicare patients better access to cutting-edge devices
Editor's Note In its proposed rule, the Centers for Medicare & Medicaid Services (CMS) would give Medicare patients better access to innovative devices beginning next year, the July 30 MassDevice reports. CMS also says it might pay more for “certain transformative new devices” for inpatients, using a new technology add-on…
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…
Editorial
Our series on artificial intelligence (AI) concludes in this issue with part 2 of an in-depth look at legal and ethical questions (cover story) as well as advice for evaluating new AI products (“Consider all angles when choosing AI technology,” p 13). But insights about future trends like AI do…
Are you prepared for the OR of the Future?
Innovative technology and surgical procedures, including artificial intelligence, will be explored in depth during the OR Manager Conference, September 18-20 in New Orleans. The new OR of the Future gives attendees a unique opportunity to learn through interactive experiences, educational sessions, and discussions with leading experts: product manufacturers as well…
Facilitate and innovate: Ensuring speedy but safe product reviews
Surgeons are the biggest factor in any effort to streamline and standardize the purchase of new surgical devices—and thereby lower costs. But surgeons often balk at getting involved in product review and selection because of the additional demands on their time. Two leading healthcare organizations have moved past this stumbling…
FDA: Class I recall of Alaris Infusion Sets
Editor's Note The Food & Drug Administration (FDA) on July 18 identified the recall by Becton Dickinson of its Alaris Infusion Sets for the Alaris Pump Model 8100 as Class I, the most serious. The recall was initiated because of the potential for tube collapse that may cause unintended or…
