Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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Editor's Note Robotic-assisted surgical procedures are no longer futuristic—they are becoming a mainstay in modern ORs. While Intuitive Surgical’s da Vinci system has led the market since 2001, competitors Medtronic and Zimmer Biomet are building innovative portfolios to challenge its dominance, MarketBeat December 12 reports. Medtronic’s Hugo Robotic Assisted Surgery…

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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…

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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…

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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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Editor's Note The US Food and Drug Administration (FDA) has updated the labels of all treatments containing GLP-1 receptor agonists with a warning about warning about pulmonary aspiration during general anesthesia or deep sedation. Drugs and brand names listed in a November 8 report on the development from MedPage Today…

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Editor's Note “There's nothing worse than putting a contract together, only for the anesthesia providers to say, ‘Oh, no, we're not going to do that,” Mindy Gingery, MSN, CRNA, ARNP, president of Heartland Anesthesia & Consulting, said, opening this morning session on anesthesia contract best practices for ambulatory surgery centers…

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Editor's Note On October 14, Anesthesiology News published a monograph featuring clinical perspectives on how “those working in the trenches of postsurgical pain management” are preparing for the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which outlines new, separate Medicare reimbursement for certain non-opioid analgesics in outpatient and ambulatory…

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Editor's Note The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages. Both efforts are in response to devastation wrought by Hurricane Helene,…

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