Safety/Quality

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July 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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Keynote preview video: Healthcare's "Blockbuster moment" with Dr Dan Weberg

Editor's Note The nursing profession has an unprecedented opportunity to redesign systems, influence policy, and elevate care—but only if we can shift from traditional models to a future-focused mindset. That's the message of this exclusive preview of the 2025 OR Manager Conference opening keynote with Dan Weberg, PhD, MHI, RN,…

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By: Matt Danford
July 22, 2025
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FDA designates Class I recall for manual resuscitator

Editor's Note The US Food and Drug Administration has designated SunMed Holdings, LLC’s recall of the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing as Class I, the most severe category indicating serious risk of injury or death. The recall is due…

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By: Matt Danford
July 21, 2025
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FDA clears handheld robotic system for ultrasound-guided needle procedures

Editor's Note Mendaera has received US Food and Drug Administration (FDA) clearance for its Focalist system, a compact robotic device that aims to improve precision in ultrasound-guided needle-based procedures. Fierce Biotech reported the news July 9. As detailed in the article, Focalist device is intended to assist with a range…

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By: Matt Danford
July 21, 2025
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Study: Algorithm offers smarter OR scheduling under pressure

Editor's Note A robust scheduling model can significantly improve OR efficiency and stability when surgery and recovery times are unpredictable, according to research published in the journal Mathematics. Using a Genetic Algorithm for Robust Scheduling (GARS), the authors demonstrate a practical and computationally efficient method for minimizing makespan across a…

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By: Matt Danford
July 21, 2025
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Preoperative, postoperative GLP-1s improve weight loss in bariatric surgery patients

Editor's Note Research shows using GLP-1 receptor agonists both before and after bariatric surgery is associated with greater total weight loss than surgery alone, according to a July 13 article in MedPage Today. The article focuses on a retrospective analysis of 568 patients presented at ENDO 2025, the annual meeting…

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By: Matt Danford
July 18, 2025
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FDA issues early alert for microbore extension sets

Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…

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By: Matt Danford
July 18, 2025
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