FDA designates Class 1 recall for angiographic catheter
Editor's Note The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death. The recall was reportedly motivated by reports of tip separation both prior to…
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…
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.…
FDA publishes Baxter update to Novum IQ infusion pump instructions addressing underinfusion risk
Editor's Note Baxter has issued a correction notice for its Novum IQ Large Volume Pump (LVP) after identifying a serious risk of underinfusion linked to the device’s standby mode and power-off conditions. First published on April 24 on the Food and Drug Administration (FDA) website and subsequently reported by Healthcare…
Study: Burn severity drives surgery timing
Editor's Note Patients with more severe burns are more likely to undergo early surgical intervention, according to a May 27 report in Physician’s Weekly summarizing a multicenter cohort study published in Burns Open. The study was based on 3,291 adult cases from three burn centers between 2009 and 2021 According…
Study: Robotic-assisted cholecystectomy raises complication risk in acute care despite similar injury rates
Editor's Note Recent research shows robotic-assisted cholecystectomy (RAC) results in similar bile duct injury rates as laparoscopic cholecystectomy (LC), but risks are higher for postoperative complications, longer hospital stays, and more frequent drain use. Published May 21 in JAMA Surgery, the large-scale cohort study analyzed outcomes from over 844,000 acute…
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…
Leapfrog safety data spotlights persistent gaps; Florida hospitals sue
Editor's Note For the first time, the Spring 2025 Hospital Safety Grade from The Leapfrog Group introduces a “Straight A” designation for facilities that have earned top marks across five or more consecutive grading cycles. Published May 1, the latest edition of this biannual safety grade shows 346 hospitals—just 12%…
Health systems boost security spending as workplace violence escalates
Editor's Note Hospitals are ramping up security in response to rising workplace violence, investing millions in weapons detection, staffing, and risk mitigation, according to an April 14 article in Modern Healthcare. Quoting executives from several large systems, the article details a shift from viewing security as a budgetary burden to…
Study: Mortality prediction models fail to recognize severe patient injuries
Editor's Note Machine learning (ML) models designed to predict patient mortality are falling short when it comes to identifying severe injuries that could lead to death, according to a March 27 report in TechTarget. The article focuses on research published in Nature Communications Medicine found that ML mortality prediction models…
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