Editor's Note In an expansive session at the 2025 OR Business Management Conference, Tampa General Hospital's emergency management team demonstrated how proactive planning, strong partnerships, and real-time decision-making helped navigate multiple crises in 2024, including back-to-back hurricanes and a cyberattack on the state's blood supply. The session was presented by Erinn…

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Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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Editor's Note The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain in adults. According to the agency’s January 30 announcement, the drug targets sodium channels in the peripheral nervous system to block pain signals before they reach the brain, representing…

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Editor's Note The US Food and Drug Administration (FDA) designated Class 1 Recalls—the most severe category indicating serious risk of injury or death—for multiple devices over the past few days, including pressure monitoring systems, emergency resuscitators, fluid delivery sets, extracorporeal blood circuits, endoscope accessories, infusion pumps, and glucose/Ketone meters. These…

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Editor’s Note Towana Looney, a 53-year-old Alabama woman, has become the longest-living recipient of a pig organ transplant, thriving 61 days after receiving a gene-edited pig kidney. The Associated Press (AP) reported the news January 25. As detailed in the article, her recovery offers critical insights into the development of…

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Editor's Note Although medical device shortages threaten all patients, a recent FDA announcement highlights particular risks for pediatric populations who require size-appropriate equipment. “From ventilators and neonatal breathing tubes to hemodialysis catheters, the scarcity of these critical devices poses a growing threat to patient care – especially for our youngest…

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Editor's Note The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics. Released January 6, draft guidance supporting the safety and effectiveness of AI-enabled devices would, if…

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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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