Regulations/Legal
HHS launches organ transplant oversight initiative after patient safety failures
Editor's Note The Department of Health and Human Services (HHS) has launched a major initiative to reform the US organ transplant system following disturbing findings about organ procurement practices. Fierce Healthcare reported the news July 21. According to the article, the initiative was triggered by a directive from HHS to…
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,…
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…
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…
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…
CMS 2026 proposed rule: Expanded ASC access, higher payments, tighter quality reporting
Editor's Note The Centers for Medicare & Medicaid Services (CMS) just proposed sweeping changes to the Medicare Shared Savings Program and Physician Fee Schedule for calendar year 2026, including extensive changes to outpatient Medicare policy such as payment increases, expanded procedural access, and new quality reporting updates, as outlined in…
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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