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…
FDA designates Class 1 recall for angiographic catheter
Editor's Note The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death. The recall was reportedly motivated by reports of tip separation both prior to…
Healthcare finance leaders shift focus to external threats amid regulatory, economic uncertainty
Editor's Note A new Deloitte report shows healthcare finance leaders are increasingly focused on external business pressures, especially federal policy changes, tariffs, and economic volatility, Chief Healthcare Executive reported June 24. In contrast to prior surveys, where workforce and internal operations were top concerns, 84% of leaders now cite external…
Johnson & Johnson launches AI fund to advance surgical innovation
Editor's Note Johnson & Johnson MedTech has launched the Polyphonic AI Fund for Surgery to accelerate the development of artificial intelligence solutions aimed at improving surgical care before, during, and after procedures. According to the company’s June 25 announcement, the initiative brings together key partners, including NVIDIA and Amazon Web…
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