Infusion pump problems prompt early FDA safety warning
Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…
AI risks top ECRI’s 2025 list of health technology hazards
Editor's Note Artificial intelligence (AI) enabled technologies present the greatest technology risk to healthcare organizations in 2025, according to the latest list from ECRI, a nonprofit organization dedicated to safety in the industry. As detailed in the organization’s December 4 announcement, the annual report highlights critical risks that healthcare organizations…
FDA designates Class 1 recall for insulin syringes
Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…
Medical device coating could reduce blood clot risks
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…
FDA pilot program aims to expedite high-risk medical device recall communication
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…
FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators
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…
Practice updates ease steam sterilization balancing act
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…
Session: Alternative options to funding—Doing more with less
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…
FDA announces Class 1 recall for pediatric resuscitator
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…
AAMI, CTA partners to develop healthcare AI standards
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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