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 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…
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…
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…
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…
Blast from the past: Revised data, evolving standards for OSA care in the perioperative setting
An estimated 22 million Americans were believed to have obstructive sleep apnea (OSA) in 2019, according to data cited in a February 2019 article published by OR Manager. At that time, up to 80% of cases were undiagnosed, and 30% to 40% of the surgical patient population was believed to…
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…
Rehab hospitals face scrutiny over safety, profits
Editor's Note Although for-profit rehab hospitals have become highly profitable, a recent KFF Health News report highlights serious safety violations, including patient deaths due to carbon monoxide poisoning, medication errors, and falls. Published July 15, the article delves into recent data and inspections of these facilities, particularly those run by…
Five underreported health changes in 'big beautiful bill'
Editor's Note Although the newly enacted One Big Beautiful Bill Act is best known for major Medicaid cuts and a temporary Medicare Physician Fee Schedule increase, it also carries significant policy changes that could affect providers, patients, and the physician workforce, MedPage Today reported July 11. The article lists five…
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…
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