Editor's Note In this OR Manager Conference session focusing on alternative funding options for capital acquisition and related consumables, Steve Spring, BA, executive finance director at Massachusetts General Hospital, outlined various strategies and considerations for managing high-value capital equipment purchases. A core challenge discussed was balancing surgeon demands for advanced…

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Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…

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Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…

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Editor's Note Odin Medical, a subsidiary of Olympus Corporation, received Food and Drug Administration (FDA) 510(k) clearance for its cloud-based AI technology, the CADDIE™ computer-aided detection device, PRNewswire September 5 reports. Designed to assist gastroenterologists in detecting colorectal polyps during colonoscopy, the AI-powered system analyzes real-time video footage and alerts…

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Editor's Note The US Food and Drug Administration (FDA) designated Baxter’s recall of certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies as Class 1, the most severe recall category indicating significant risk of injury or death. The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit…

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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 Many current instructions for use (IFUs) are considered overly complex, outdated, and difficult to interpret, especially for…

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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…

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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…

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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…

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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…

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