Rules and Regulations
Antitrust guideline withdrawal could dampen M&A, boost uncertainty for provider joint ventures
Editor's Note In a move that could hinder provider-led joint ventures and increase regulatory uncertainty, the Federal Trade Commission (FTC) and the Justice Department have withdrawn antitrust guidance issued in 2000. Modern Healthcare reported the news on December 16. Passed in a 3-2 vote, the decision eliminates previously relied-upon safe…
Infusion pump problems prompt early FDA safety warning
Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…
Analysis: Guidance from leading medical journals mixed on AI use
Editor's Note Leading medical journals vary significantly in guidance addressing the use artificial intelligence (AI) in medical research, according to an analysis published December 3 in JAMA Network Open. The study categorized journals’ attitudes toward AI-assisted peer review into three groups: prohibition, limited use with conditions, and lack of explicit…
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…
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…
Study: Masking policies significantly reduce hospital-acquired viral respiratory infections
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,…
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…
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…
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…
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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