Supply Chain/Technology

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November 2025
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FDA designates Class I recall for arterial cannulae due to exposed wire risk

Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…

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By: Matt Danford
July 25, 2025
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FDA designates Class I recall for mobile lift component

Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…

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By: Matt Danford
July 24, 2025
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Navigating OR construction design, compliance, approval in a booming ASC market

Editor’s Note: This page is a companion piece to the main article, Proper planning prevents OR construction, renovation cost creep. It brings together four focused updates on OR and ambulatory surgery center (ASC) construction and renovation: Regulatory shifts: The Joint Commission's updated safety and sustainability requirements for hospitals and ASCs, including new…

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By: Uyen Vo
July 23, 2025
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FDA issues safety alert for Baxter Novum IQ large volume pumps

Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus).   According to the agency’s July 22…

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By: Matt Danford
July 23, 2025
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Report: AI, third-party risks open gaps in healthcare cybersecurity

Editor's Note Serious cybersecurity vulnerabilities remain in healthcare despite significant improvements in recent years, according to a July 16 MedCity News report on recent data from cybersecurity firm Fortified Health Security. Fortified’s research, which reportedly draws on NIST CSF data and first–hand experience from the field, assesses the state of…

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By: Matt Danford
July 23, 2025
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Proper planning prevents OR construction, renovation cost creep

How would you describe the ideal OR? Whatever the answer, the chance to reimagine and reshape the perioperative suite can be among the most exciting projects of a perioperative leader’s career. However, OR construction and renovation also can be among the most daunting projects of a perioperative leader’s career. Just…

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By: Uyen Vo
July 23, 2025
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FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators

Editor's Note The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death. As detailed in a July 22 FDA announcement,…

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By: Matt Danford
July 22, 2025
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Humanoid robots show early promise in clinical procedures, but technical limits remain

Editor's Note Adapting general-purpose humanoid robots already trained on large-scale industrial tasks for use in surgery could provide a solution to burnout, understaffing and other problems. This is the primary takeaway of a July 9 article from UC San Diego detailing the work of robotics expert Michael Yip, who has…

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By: Matt Danford
July 22, 2025
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AI tools monitor, reduce OR infection risks

Editor's Note AI-enabled sensors, smart surveillance systems, and predictive analytics are advancing perioperative workflows while helping prevent breaches that can lead to surgical site infections (SSIs). This is the primary takeaway of a July 15 Q&A with Herman DeBoard, PhD, CEO of Huvr Inc., in Infection Control Today. As detailed…

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By: Matt Danford
July 22, 2025
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Hospitals pioneer methods to overcome DCD barriers, expand lifesaving transplants

Editor's Note Surgeons at Duke and Vanderbilt universities have devised simpler methods to retrieve donor hearts after circulatory death, according to a July 16 report from the Associated Press (AP). The research, published in the New England Journal of Medicine, details successful heart transplants using organs from donors whose hearts…

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By: Matt Danford
July 22, 2025
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