Editor's Note The US Food and Drug Administration (FDA) designated recalls of Medtronic’s NIM Vital Nerve Monitoring System and Smith Medical’s CADD-Solis Ambulatory Infusion Pumps as Class 1, the most severe category indicating serious risk of injury or death. Reports of false negative responses prompted Medtronic to recall the nerve…

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Editor's Note The American Hospital Association (AHA) criticized new inpatient prospective payment system rates issued August 1 by the Centers for Medicare and Medicaid Services (CMS), citing the potential of financial struggles for hospitals and reduced access for patients, particularly in rural or underserved areas. Under the new rule, most…

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Editor's Note Having served six terms in Congress and as Governor of Minnesota since 2018, Democratic vice-presidential nominee Tim Walz has a long history of involvement in healthcare issues. MedPage Today published an overview of his track record on August 6, drawing on sources including ABC News, Star-Tribune, and the…

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Editor's Note A CMS citation for immediate jeopardy this past June allegedly resulted in the cancellation of nearly 1,000 surgeries at Doctors Medical Center in Modesto, California, according to a July 30 article in Becker’s ASC Review. Citing a July 26 letter from California Assemblymen Heath Flora and Juan Alanis…

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Editor's Note The Supreme Court’s recent “Chevron” ruling could offer additional financial security to hundreds of so-called "tweener" rural hospitals—those too large to be considered critical access hospitals but too small to be rural referral centers. Modern Healthcare reported the news July 29. According to the article, critical access hospitals,…

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Editor's Note In a new guidance document for manufacturers of pharmaceuticals and biopharmaceuticals, The Association for the Advancement of Medical Instrumentation (AAMI) has released a new guidance document updating best practices for radiation sterilization validation and routine control of single-use systems. The document, AAMI CR513:2024; Guidance on radiation sterilization validation and…

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Editor's Note The American Medical Association (AMA) annual, nationwide prior authorization survey reveals that over 90% of physicians believe prior authorization negatively impacts patient clinical outcomes. “More telling,” AMA reported July 17, is the fact that 78% of physicians report that this process “sometimes or often” leads to patients abandoning…

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Editor's Note New findings highlight an urgent need to improve preventive measures against animal-borne diseases jumping to humans and potentially causing another global pandemic, US Today reported on July 21. The article details a study from  Harvard Law School and New York University that examined animal-human interactions in 15 countries,…

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Editor's Note:  Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…

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Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…

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