Tag: risk

FDA designates Class 1 recalls for EVH system, infusion pump

Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…

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By: Matt Danford
July 16, 2025
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FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape

Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…

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By: Matt Danford
July 10, 2025
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FDA early alerts flag pump controllers, software

Editor's Note Recent early alerts from the US Food and Drug Administration (FDA), issued when the agency becomes aware of potentially high-risk issues, involve Abiomed’s Automated Impella Controller (AIC) and infusion pump software from Baxter. The AIC system, which is the user control interface for the Impella catheter blood pump,…

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By: Matt Danford
July 7, 2025
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Healthcare finance leaders shift focus to external threats amid regulatory, economic uncertainty

Editor's Note A new Deloitte report shows healthcare finance leaders are increasingly focused on external business pressures, especially federal policy changes, tariffs, and economic volatility, Chief Healthcare Executive reported June 24. In contrast to prior surveys, where workforce and internal operations were top concerns, 84% of leaders now cite external…

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By: Matt Danford
June 26, 2025
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Surgeons perform first dual-organ transplant on LVAD patient

Editor's Note A Florida transplant team has performed the first-ever heart-liver transplant in a patient supported by a left ventricular assist device (LVAD), offering a potential new treatment route for those previously ineligible due to high rejection risk, CBS News reported June 21. The patient, whose antibody levels placed her…

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By: Matt Danford
June 25, 2025
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Study: Surgical patients face higher odds of food insecurity

Editor's Note New research shows surgical patients in the US face a significantly greater risk of food insecurity than nonsurgical patients, even after adjusting for demographic and socioeconomic differences. Findings also point to potential underutilization of the Supplemental Nutritional Assistance Program (SNAP) benefits among surgical patients, study authors write.  …

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By: Matt Danford
June 20, 2025
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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.…

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By: Matt Danford
June 17, 2025
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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…

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By: Tarsilla Moura
June 9, 2025
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Study: Pneumonia risk lower for COVID-19 than influenza, RSV

Editor's Note Influenza and RSV infections more than double the risk of secondary Streptococcus pneumoniae infection, while COVID-19 is associated with a significantly reduced risk, according to a June 2 news brief from the Center for Infectious Disease Research and Policy (CIDRAP). The findings stem from a retrospective study of…

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By: Matt Danford
June 5, 2025
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Study highlights surgical slush sterility, heart health risks

Editor's Note Researchers studying the exposure of sterile surgical slush to open air urge the adoption of closed-system technology to alleviate risks to sterility and surgical outcomes, according to a May 19 article in OR today. The article focuses on a time and motion study led by perioperative nursing leaders…

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By: Matt Danford
May 29, 2025
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