Editor's Note Researchers at the University of British Columbia (UBC) say their newly created coating could enhance the safety of medical devices by reducing the risks of thrombosis and excessive bleeding in patients. As reported November 30 in Fox News, researchers' findings, published in the journal Nature Materials, highlight how…

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Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…

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Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…

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Reliable and robust enough for daily use on most medical devices, steam is the most common sterilant in healthcare facilities. However, using steam properly requires a balancing act. For example, too much moisture can lead to wet packs, while steam that is too dry might not be sufficient to achieve…

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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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