Rules and Regulations

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June 2024
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Joint Commission identifies most cited certification performance requirements

Editor's Note Recognizing that complying with some standards is more difficult than complying with others, The Joint Commission regularly evaluates which areas are most difficult so it can tailor education accordingly. To that end, a May 7 report reveals the top 5 most frequently cited elements of performance (EPs) in…

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By: Matt Danford
May 10, 2024
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Kaiser Permanente data breach affects 13.4 million

Editor's Note A recent data breach at Kaiser Permanente could impact as many as 13.4 million people who are part of the healthcare conglomerate’s Kaiser Foundation Health Plan, according to the Department of Health and Human Services (HHS). Fox Business reported the news April 29. The breach was first reported…

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By: Matt Danford
May 1, 2024
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FDA medical device Class 1 recalls trend upward

Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25.  According to the report, Anne Reid, program director of the Office…

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By: Matt Danford
April 29, 2024
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The Joint Commission launches new telehealth accreditation program

Editor's Note Effective July 1, telehealth providers can apply for a new Joint Commission accreditation designed to ensure safe, high-quality care. Announced April 23 by The Joint Commission, the new Telehealth Accreditation Program is designed for organizations that exclusively provide care, treatment and services via telehealth. Hospitals and other healthcare…

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By: Matt Danford
April 29, 2024
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FDA announces class 1 recall for disposable biopsy needle kit

Editor's Note Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy…

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By: Matt Danford
April 29, 2024
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Getting ready for the OAS CAHPS Survey 2025 requirement

Editor's Note Starting in 2025, Medicare-certified ambulatory surgery centers (ASCs) will be required to participate in the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey to comply with the ASC Quality Reporting Program, reports the Ambulatory Surgery Center Association (ASCA) and Outpatient Surgery Magazine…

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By: Tarsilla Moura
April 24, 2024
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FDA approves imaging drug for detecting cancer after lumpectomy

Editor's Note The US Food and Drug Administration (FDA) approved Lumisight (pegulicianine), a fluorescent imaging drug used to detect cancerous tissue during lumpectomy, on April 17. Administered intravenously prior to surgery, Lumisight is designed for use with the Lumicell Direct Visualization System (DVS) or another imaging device that is FDA-approved…

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By: Matt Danford
April 22, 2024
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Penn Medicine anesthesia, waste initiatives boost OR sustainability

Editor's Note Penn Medicine has made significant strides in reducing the environmental footprint of the OR through department- and team-level initiatives, according to a March 29 report in Penn Medicine news. Driven by CIRCE: Medicine, a faculty group consisting of providers from Penn Medicine and Children’s Hospital of Philadelphia, examples…

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By: Matt Danford
April 22, 2024
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FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence

Editor's Note Mini-slings for stress urinary incontinence (SUI) are similarly effective to mid-urethral slings over a 36-month timeframe, according to an April 11 announcement from the US Food & Drug Administration (FDA). FDA reached this conclusion after an in-depth, systematic literature review of post-market surveillance (“522”) studies required last year…

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By: Matt Danford
April 15, 2024
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Federal regulations require written consent for pelvic exams at hospitals, medical schools

Editor's Note New federal guidelines require obtaining written informed consent before conducting pelvic and other sensitive medical examinations, according to an April 2 Associated Press report. The new guidance from the US Department of Health and Human Services focuses specifically on medical students, nurse practitioners, and physician assistants performing breast,…

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By: Matt Danford
April 15, 2024
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