Rules and Regulations

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March 2025
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Advanced practice providers fill capacity gaps amid continued scope-of-practice debates

Editor's Note A recent report in Becker’s Hospital Review illuminated health systems’ efforts to address physician shortage by integrating advanced practice providers (APPs) into care models. Citing projections from the Bureau of Labor Statistics (BLS), Becker’s noted that nurse practitioners (NPs) “are the fastest-growing occupation in the country, with employment in…

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By: Matt Danford
December 6, 2024
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FDA designates Class 1 recall for insulin syringes

Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…

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By: Matt Danford
December 5, 2024
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Study: Masking policies significantly reduce hospital-acquired viral respiratory infections

JAMA (healthcare publication) Network logo

Editor's Note A cohort study conducted across 10 hospitals in the Mass General Brigham system found that stopping universal masking and SARS-CoV-2 testing significantly increased hospital-onset respiratory viral infections, while reinstating masking for healthcare workers reduced those rates. As detailed in a November 27 research letter in Jama Network Open,…

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By: Matt Danford
December 5, 2024
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HHS finalizes rule to expand kidney transplant access

Editor's Note The US Department of Health and Human Services (HHS) finalized a new rule establishing the Increasing Organ Transplant Access Model, a 6-year, mandatory initiative to enhance access to kidney transplants, improve care quality, and reduce disparities. Managed by the Centers for Medicare & Medicaid Services (CMS), the program…

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By: Matt Danford
December 4, 2024
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FDA pilot program aims to expedite high-risk medical device recall communication

Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…

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By: Matt Danford
December 2, 2024
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FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators

Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…

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By: Matt Danford
November 20, 2024
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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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Tardiness policies fine-tune rural OR reform efforts

When a speaker at a recent conference asked if anyone had achieved a first-case on-time start (FCOTS) rate above 90%, Jay Parker, BSN, RN, could have been the only one in the room with his hand up. However, Parker was not inclined to call attention to himself. As director of…

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By: Matt Danford
November 20, 2024
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GAO urges HHS to strengthen cybersecurity oversight

Editor's Note A November 13 report from The Government Accountability Office (GAO) identifies critical gaps in the Department of Health and Human Services' (HHS) ability to manage cybersecurity risks in the healthcare and public health sector. HHS, the lead federal agency for cybersecurity in this sector, faces challenges in monitoring…

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By: Matt Danford
November 19, 2024
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AMA urges stronger radiation protections

Editor's Note Amid growing concerns about healthcare workers’ exposure to ionizing radiation and its associated cancer risks, the American Medical Association (AMA) House of Delegates called for increased protective measures and standardized guidelines, including improved exposure metrics, during their interim meeting in Orlando, Florida. MedPage Today reported the news November…

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By: Matt Danford
November 18, 2024
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