Tag: Rules and Regulations

Practice updates ease steam sterilization balancing act

Reliable and robust enough for daily use on most medical devices, steam is the most common sterilant in healthcare facilities. However, using steam properly requires a balancing act. For example, too much moisture can lead to wet packs, while steam that is too dry might not be sufficient to achieve…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
November 20, 2024
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AHA's Congressional "wish list" calls for financial relief, patient access, workforce protections

Editor's Note   In a November 12 letter to Congress, the American Hospital Association (AHA) outlined its priorities for the lame-duck legislative session, focusing on measures to stabilize hospitals and health systems facing significant financial and operational pressures. If enacted, these recommendations would support the nation’s healthcare infrastructure amid rising…

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By: Matt Danford
November 14, 2024
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Private Equity fuels growth of hospital-owned ASCs amidst rising demand, regulatory loopholes

Editor's Note Private equity investment in hospital-owned ambulatory surgery centers (ASCs) is rising as hospitals seek expansion capital and private equity firms look for profitable partnerships in a growing sector, Modern Healthcare November 4 reports. ASCs have become popular due to their lower costs compared to hospitals, which makes them…

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By: Tarsilla Moura
November 6, 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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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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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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CMS proposes $2 Drug List Model to reduce out-of-pocket costs for Medicare recipients

Editor's Note CMS has taken the next steps in making prescription drugs more affordable for Medicare recipients, according to an October 9 report from The US Department of Health and Human Services (HHS). The proposed Medicare $2 Drug List Model, developed in line with President Biden’s Executive Order 14087, aims…

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By: Matt Danford
October 9, 2024
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FDA announces Class 1 recall for pediatric resuscitator

Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…

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By: Matt Danford
October 7, 2024
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AAMI, CTA partners to develop healthcare AI standards

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…

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By: Matt Danford
October 3, 2024
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