Regulations/Legal

Latest Issue of OR Manager
November 2024
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Trump vs. Harris: Key differences in healthcare proposals for Medicaid, Medicare, private insurance, abortion

Editor's Note When it comes to the 2024 presidential election, “Neither candidate addresses a return to the fundamental tenet of healthcare: the patient-physician relationship,” reads the closing line of an “election guide” from Richard Menger MD MPA. In the preceding paragraph, Menger also argues that both candidates also neglect issues…

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By: Matt Danford
November 4, 2024
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Updated AAMI standard addresses chemical sterilization safety, compliance

Editor's Note New guidance from The Association for the Advancement of Medical Instrumentation (AAMI) addresses regulatory and safety concerns for hospitals using ethylene oxide (EO) for medical device sterilization—a pressing concern due to EO’s effectiveness but associated health risks. ANSI/AAMI ST58:2024, an update on chemical sterilization and high-level disinfection practices…

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By: Matt Danford
November 4, 2024
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Session: Empowered nurses advocate for policy change, workplace safety

Editor's Note Real-world experience in Texas—where more than 650 nurses marched on the capitol in support of workplace violence legislation—informed much of yesterday’s OR Manager Conference presentation on nurse legislative and policy advocacy from Serena Bumpus, DNP, RN, NEA-BC. Although nurses make up the largest healthcare workforce—around 5.2 million across…

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By: Matt Danford
October 28, 2024
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Medicare Advantage insurers prioritize profits over patients, Senate reports

Editor's Note A Senate report reveals that Medicare Advantage insurers are increasingly prioritizing profits over patient care by ramping up the use of prior authorization to deny necessary services, particularly post-acute care, for older adults, Becker’s Hospital Review reported October 17. In May 2023, the Senate Permanent Subcommittee on Investigations…

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By: Matt Danford
October 22, 2024
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Feds warn of increased healthcare cyber threats from Iranian actors

Editor's Note Iranian cyber actors employing techniques such as brute force, password spraying, and multifactor authentication (MFA) "push bombing" to compromise healthcare and other critical infrastructure sectors, the American Hospital Association (AHA) reported October 17. The report cites an October 16 joint advisory issued on October 16 by the FBI,…

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By: Matt Danford
October 21, 2024
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OR “megafloor” combines inpatient, outpatient procedures

Editor's Note A newly constructed surgical “megafloor” that connects inpatient and outpatient ORs promises to aid workflow and add flexibility for perioperative teams at The University of California Irvine (UCI) Health—Irvine campus, Healthcare Design reported October 7. As detailed in the article, the academic center must accommodate a variety of…

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By: Matt Danford
October 21, 2024
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Outpatient, ASC clinicians share perspectives on upcoming NOPAIN Act implementation

Editor's Note On October 14, Anesthesiology News published a monograph featuring clinical perspectives on how “those working in the trenches of postsurgical pain management” are preparing for the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which outlines new, separate Medicare reimbursement for certain non-opioid analgesics in outpatient and ambulatory…

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By: Matt Danford
October 16, 2024
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Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance

Editor's Note The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages. Both efforts are in response to devastation wrought by Hurricane Helene,…

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By: Matt Danford
October 16, 2024
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FDA designates Class 1 recall for infusion pumps due to air bubble risk

Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to  a defect in…

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By: Matt Danford
October 14, 2024
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Medicare policy on prior authorization falls short on shifting outpatient surgery trends

Editor's Note A Medicare policy introduced in 2020, which requires prior authorization for certain procedures done at hospital outpatient departments (HOPDs), has not significantly reduced the volume of surgical procedures being done at these facilities, reports a study by Michigan Medicine, University of Michigan, published on October 9. The policy,…

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By: Tarsilla Moura
October 9, 2024
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