Rules and Regulations

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July 2025
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Judge orders restoration of deleted federal health data

Editor's Note A federal judge has ordered the Trump administration to restore health-related webpages and datasets removed under a January executive order, according to a July 29 article in Medscape. The ruling follows a lawsuit by Doctors for America and the city and county of San Francisco, which argued that…

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By: Matt Danford
July 30, 2025
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Joint Commission to tailor accreditation standards for children’s hospitals

Editor's Note The Joint Commission has launched a new strategy to revise its accreditation and certification programs to better reflect the distinct needs of pediatric care. According to a July 29 announcement, the effort responds to requests from the children’s health community and aims to revise or remove standards that…

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By: Matt Danford
July 30, 2025
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FDA designates Class I recall for disposable surgical stapler cartridge correction

Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement,  the recall…

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By: Matt Danford
July 28, 2025
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FDA designates Class I recall for arterial cannulae due to exposed wire risk

Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…

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By: Matt Danford
July 25, 2025
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FDA designates Class I recall for mobile lift component

Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…

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By: Matt Danford
July 24, 2025
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CMS payment overhaul could cut specialist pay

Editor's Note A “quiet transformation” in how Medicare pays doctors could reduce payments for specialty care, including rates for billing codes associated with surgery, diagnostic imaging, outpatient care, pain management, and orthopedics, Modern Healthcare July 22 reports. According to the article, The Centers for Medicare and Medicaid Services (CMS) 2026…

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By: Matt Danford
July 24, 2025
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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…

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By: Matt Danford
July 23, 2025
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Proper planning prevents OR construction, renovation cost creep

How would you describe the ideal OR? Whatever the answer, the chance to reimagine and reshape the perioperative suite can be among the most exciting projects of a perioperative leader’s career. However, OR construction and renovation also can be among the most daunting projects of a perioperative leader’s career. Just…

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By: Uyen Vo
July 23, 2025
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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…

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By: Matt Danford
July 22, 2025
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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,…

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By: Matt Danford
July 22, 2025
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