Rules and Regulations

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September 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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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…

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By: Matt Danford
July 17, 2025
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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…

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By: Matt Danford
July 17, 2025
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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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By: Matt Danford
July 16, 2025
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CMS proposes 2026 Medicare pay bump, targets wasteful spending

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has proposed a 3.62% increase to the 2026 Medicare physician fee schedule, according to a July 14 article in Fierce Healthcare. The proposed rule sets the conversion factor at $33.42, up from $32.35 in 2025. The increase reflects a 2.5%…

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By: Matt Danford
July 15, 2025
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Professional development: Cockpit view clears credentialing terminology turbulence

Comparing healthcare to aviation is a long-standing tradition, especially when discussing safety systems like checklists. However, the similarities extend beyond protocols. Just as flying a paper airplane differs vastly from piloting a jumbo jet, so too does earning a certificate of attendance differ from achieving professional certification. Parallels like these…

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By: Dawn Whiteside
July 15, 2025
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Medicare faces automatic cuts as GOP tax law triggers PAYGO penalties

Editor's Note President Donald Trump’s “One Big Beautiful Bill” could trigger more than $500 billion in Medicare cuts over the next decade unless Congress waives automatic spending rules, according to a July 9 article in Modern Healthcare. As detailed in the article, the legislation’s projected $3.4 trillion increase to the…

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By: Matt Danford
July 10, 2025
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FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape

Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…

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By: Matt Danford
July 10, 2025
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Patient falls, wrong surgeries, care delays lead rise in sentinel events

Editor's Note Sentinel events reported to The Joint Commission increased by 12% in 2024, with patient falls once again leading the list of serious adverse events followed by wrong surgeries. The Joint Commission released the data in an annual review July 9.     Wrong surgery events increased 13% from the…

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By: Matt Danford
July 9, 2025
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Researchers link full practice laws for APRNs to better state health rankings

Editor's Note States that grant full practice authority to advanced practice registered nurses (APRNs) rank significantly higher in health system performance than those that impose physician supervision requirements, according to a July 3 report from the University of Missouri. The article focuses on a study led by researchers at the…

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By: Matt Danford
July 9, 2025
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