FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
Navigating OR construction design, compliance, approval in a booming ASC market
Editor’s Note: This page is a companion piece to the main article, Proper planning prevents OR construction, renovation cost creep. It brings together four focused updates on OR and ambulatory surgery center (ASC) construction and renovation: Regulatory shifts: The Joint Commission's updated safety and sustainability requirements for hospitals and ASCs, including new…
HHS launches organ transplant oversight initiative after patient safety failures
Editor's Note The Department of Health and Human Services (HHS) has launched a major initiative to reform the US organ transplant system following disturbing findings about organ procurement practices. Fierce Healthcare reported the news July 21. According to the article, the initiative was triggered by a directive from HHS to…
FDA designates Class I recall for manual resuscitator
Editor's Note The US Food and Drug Administration has designated SunMed Holdings, LLC’s recall of the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing as Class I, the most severe category indicating serious risk of injury or death. The recall is due…
CMS proposes 2026 Medicare pay bump, targets wasteful spending
Editor's Note The Centers for Medicare & Medicaid Services (CMS) has proposed a 3.62% increase to the 2026 Medicare physician fee schedule, according to a July 14 article in Fierce Healthcare. The proposed rule sets the conversion factor at $33.42, up from $32.35 in 2025. The increase reflects a 2.5%…
Medicare faces automatic cuts as GOP tax law triggers PAYGO penalties
Editor's Note President Donald Trump’s “One Big Beautiful Bill” could trigger more than $500 billion in Medicare cuts over the next decade unless Congress waives automatic spending rules, according to a July 9 article in Modern Healthcare. As detailed in the article, the legislation’s projected $3.4 trillion increase to the…
Patient falls, wrong surgeries, care delays lead rise in sentinel events
Editor's Note Sentinel events reported to The Joint Commission increased by 12% in 2024, with patient falls once again leading the list of serious adverse events followed by wrong surgeries. The Joint Commission released the data in an annual review July 9. Wrong surgery events increased 13% from the…
Researchers link full practice laws for APRNs to better state health rankings
Editor's Note States that grant full practice authority to advanced practice registered nurses (APRNs) rank significantly higher in health system performance than those that impose physician supervision requirements, according to a July 3 report from the University of Missouri. The article focuses on a study led by researchers at the…
FDA inspections slow as support staff layoffs strain overseas oversight
Editor's Note Logistical staff layoffs at the US Food and Drug Administration (FDA) are hindering the agency’s ability to scrutinize drug manufacturing safety in foreign countries, according to a July 7 report in ProPublica. A spokesperson from the US Department of Health and Human Services (HHS) told ProPublica that FDA…
Health systems slash jobs amid mounting financial pressures
Editor's Note A recent report in Becker’s Hospital Review outlines six recent examples of hospitals and health systems laying off workers in response to deepening financial strain. In a separate report, the outlet listed 11 hospitals and health systems that received credit rating downgrades from Fitch Ratings or Moody’s Investors…
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