Rules and Regulations

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July 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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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,…

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By: Matt Danford
July 7, 2025
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ASC adaptability depends on properly structured leadership

Takeaways • Different types of ASC leadership structures can be adapted to meet organizational needs. • Regulations, accreditation standards, size, and ownership types are examples of factors influencing the leadership structure. • Ongoing success of the ASC leadership team depends on factors such as governing body diversity and strategic planning.…

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By: Cynthia Saver, MS, RN
July 1, 2025
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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…

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By: Matt Danford
June 30, 2025
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The Joint Commission announces accreditation overhaul

Editor's Note The Joint Commission has launched a major redesign of its healthcare accreditation and certification programs with Accreditation 360: The New Standard. According to a June 30 announcement, the new framework introduces outcome-focused performance tools, eliminates hundreds of requirements, and promises to made standards publicly accessible. Reportedly supported by…

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By: Matt Danford
June 30, 2025
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Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula

Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…

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By: Matt Danford
June 25, 2025
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Major insurers pledge prior authorization reform

Editor's Note Nearly 50 major US health insurers—including UnitedHealthcare, Aetna, Cigna, Elevance, and Humana—have pledged to reform prior authorization practices, with the goal of easing administrative burdens and improving access to care, according to a June 23 article in Healthcare Dive. As detailed in the article, the announcement came from…

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By: Matt Danford
June 25, 2025
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OR Business Management Summit Announces 2026 Program Committee 

Rockville, MD—June 24, 2025—OR Business Management Summit announced today its 2026 Program Committee—a dedicated, diverse team of perioperative business management leaders with deep experience in operational efficiency, financial performance, and strategic OR leadership. The event will take place February 9–11, 2026, at the Hilton Austin in Austin, TX.  A strategically…

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By: Barbara Cucci
June 24, 2025
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FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes

Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…

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By: Matt Danford
June 18, 2025
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