Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula
Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…
FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes
Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…
Study: Language barriers raise sepsis death risk despite faster treatment
Editor's Note Patients hospitalized with sepsis who have limited English proficiency (LEP) face significantly higher odds of dying in the hospital even after accounting for multiple demographic and clinical factors, according to research presented at the American Thoracic Society International Conference by researchers from UC San Diego. Healio reported the…
Lung transplant waitlist deaths drop under new composite allocation system
Editor's Note Implementation of the Composite Allocation Score (CAS) in lung transplantation significantly reduced the proportion of patients who died or were removed from the waitlist, including those with the most urgent medical need, according to a June 17 article in Healio. The findings were presented at the American Thoracic…
FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate
Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2, Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…
Post-pandemic surge in excess US deaths exposes public health decline
Editor's Note The United States recorded more than 1.5 million excess deaths in 2022 and 2023 alone—avoidable fatalities that would not have occurred if US death rates matched those of other wealthy nations, according to a May 23 article in CIDRAP reporting on a Boston University–led study published in JAMA…
Study: Long working hours alter brain regions tied to emotion, cognition
Editor's Note Clocking long hours has impact beyond fatigue. It may also physically reshape the brain. As reported May 13 by CNN, that is the central finding of a new study showing significant structural brain changes in overworked individuals, particularly in areas tied to emotional regulation and executive function. Conducted…
Report: Global nurse shortage widens inequities, fuels migration risks
Editor's Note Wealthy nations continue to draw nurses from poorer countries, worsening fragile healthcare systems and deepening global inequities, according to the newly released State of the World’s Nursing 2025 report from the World Health Organization (WHO) and International Council of Nurses (ICN). As detailed in a May 12 article…
Power loss risks prompt FDA Class 1 recall designation for heart pump accessories
Editor's Note Sudden, unexpected shutdown and restart prompted the US Food and Drug Administration (FDA) to designate a class 1 recall—the most severe category reserved for serious risk of injury or death—for Abbot’s HeartMate Mobile Power Unit, which powers system controllers for the HeartMate 3 Left Ventricular Assist System (LVAS)…
Study: US maternal mortality rises 28% in 5 years, inequities persist
Editor's Note Pregnancy-related deaths in the US rose sharply from 2018 to 2022, with rates 3.8 times higher among American Indian and Alaska Native women and 2.8 times higher among non-Hispanic Black women than among White women, according to a new study published April 9 in JAMA Network Open. Researchers…
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