Tag: FDA

Infusion pump problems prompt early FDA safety warning

Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…

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By: Matt Danford
December 12, 2024
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FDA designates Class 1 recall for insulin syringes

Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…

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By: Matt Danford
December 5, 2024
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FDA pilot program aims to expedite high-risk medical device recall communication

Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…

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By: Matt Danford
December 2, 2024
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FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators

Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…

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By: Matt Danford
November 20, 2024
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GLP-1 labels carry pulmonary aspiration warning

Editor's Note The US Food and Drug Administration (FDA) has updated the labels of all treatments containing GLP-1 receptor agonists with a warning about warning about pulmonary aspiration during general anesthesia or deep sedation. Drugs and brand names listed in a November 8 report on the development from MedPage Today…

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By: Matt Danford
November 12, 2024
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Session: Anesthesia contracts, the must-haves

Editor's Note “There's nothing worse than putting a contract together, only for the anesthesia providers to say, ‘Oh, no, we're not going to do that,” Mindy Gingery, MSN, CRNA, ARNP, president of Heartland Anesthesia & Consulting, said, opening this morning session on anesthesia contract best practices for ambulatory surgery centers…

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By: Tarsilla Moura
October 28, 2024
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Outpatient, ASC clinicians share perspectives on upcoming NOPAIN Act implementation

Editor's Note On October 14, Anesthesiology News published a monograph featuring clinical perspectives on how “those working in the trenches of postsurgical pain management” are preparing for the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which outlines new, separate Medicare reimbursement for certain non-opioid analgesics in outpatient and ambulatory…

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By: Matt Danford
October 16, 2024
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Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance

Editor's Note The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages. Both efforts are in response to devastation wrought by Hurricane Helene,…

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By: Matt Danford
October 16, 2024
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FDA designates Class 1 recall for infusion pumps due to air bubble risk

Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to  a defect in…

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By: Matt Danford
October 14, 2024
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FDA announces Class 1 recall for pediatric resuscitator

Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…

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By: Matt Danford
October 7, 2024
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