APIC calls for improved medical device reprocessing instructions, guidelines
Editor’s Note The Association for Professionals in Infection Control and Epidemiology (APIC) is advocating for clearer reprocessing instructions for medical devices to improve patient safety and efficiency, Outpatient Surgery Magazine August 19 reports. Many current instructions for use (IFUs) are considered overly complex, outdated, and difficult to interpret, especially for…
Some FDA-recalled medical devices remain in use while manufacturers implement corrections
Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…
Handheld, powered surgical tools combine advantages of traditional laparoscopy, robotics
Editor's Note Combining dexterity and cost-effectiveness, handheld robotic devices offer potential to bridge the gap between traditional laparoscopy and more expensive robotic platforms, researchers concluded August 8 in the journal Surgery. The mini-review of clinical trials covered clinical applications of three handheld robotic devices: the HandX powered laparoscopic instrument from…
FDA announces Class 1 recall for chest compression devices
Editor's Note The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death. A motor issue could stop compressions in adults whose hearts suddenly stop, according to the…
Battery problem prompts FDA Class 1 recall for infusion pumps
Editor's Note The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death. According to he agency’s August 20 announcement, the company is updating…
FDA: Ventilator death, injury reports lower than initially reported
Editor's Note: Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…
FDA announces Class 1 recalls for ventilator software, electrode pads
Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…
FDA announces Class 1 recalls for upper airway stimulation system, MRI components
Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…
FDA issues Class 1 recalls for two ventilator models
Editor's Note Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…
FDA announces Class 1 recalls for patient return electrodes, intra-aortic balloon catheters, anesthesia systems
Editor's Note The US Food & Drug Administration (FDA) has announced Class 1 recalls—the most severe category, indicating risk of serious injury or death—for three products: MEGA SOFT Pediatric Patient Return Electrodes from Megadyne, Vaporizer Sevoflurane Maquet Filling from Getinge; and Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex…
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