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…
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…
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,…
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…
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…
FDA designates Class 1 recall for cranial drill
Editor's Note The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death. As detailed in the agency’s July 16 announcement, the recall of the single-use cranial…
FDA designates Class 1 recalls for EVH system, infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…
Scrubs to startups: Viral neurosurgeon is breaking barriers, fixing spines, advocating for safer ORs
When Betsy Grunch, MD, FAANS, FACS, FCNS, board-certified neurosurgeon known on TikTok and Instagram as @Ladyspinedoc, watched a viral video of a surgeon berating an OR nurse during a livestreamed procedure, she was incredibly bothered by the shameful display. She took to her popular platform and spoke out against that…
FDA early alerts flag pump controllers, software
Editor's Note Recent early alerts from the US Food and Drug Administration (FDA), issued when the agency becomes aware of potentially high-risk issues, involve Abiomed’s Automated Impella Controller (AIC) and infusion pump software from Baxter. The AIC system, which is the user control interface for the Impella catheter blood pump,…
Hidden head injury hazards expose cracks in OR safety culture
One of the most sobering moments in the career of anesthesiologist Cornelius Sullivan, MD, occurred not as a caretaker in the OR, but as a patient in the emergency department. Having been knocked out cold by a low-hanging monitor during a surgical procedure at Boston Children’s Hospital, he had to…
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