Editor's Note The US Food and Drug Administration (FDA) has deemed Smiths Medical’s recall of Proport Plastic Implantable Ports a Class 1, the most severe designation indicating serious risk of injury or death. The devices are designed for repeated venous access for injections, infusions, and/or blood samples. According to the…

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Editor's Note Endovascular devices used to block aneurysm blood flow are the subject of the latest recall to be designated Class 1—the most severe designation indicating serious risk of injury or death—by the US Food and Drug Administration (FDA). As detailed in the agency’s March 18 announcement, Medtronic Neurovascular is…

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Editor's Note The American College of Gastroenterology (ACG) is warning that millions of Americans could lose access to essential colorectal cancer (CRC) screenings if the Supreme Court rules against the role of the US Preventive Services Task Force (USPSTF) in guiding preventive care coverage. According to the organization’s March 7…

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Editor's Note A systematic review found no strong evidence that compliance with the CMS Severe Sepsis and Septic Shock Management Bundle (SEP-1) reduces mortality, raising questions about its inclusion in hospital performance measures, according to a February 19 report from the University of Minnesota’s Center for Infectious Disease Research and…

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Editor's Note A March 4 study in JAMA Network Open underscores the persistence of the “weekend effect,” a surgical care phenomenon in which the risk of postoperative complications, readmissions and mortality rises immediately before the weekend. The research suggests variations in staffing, resource availability, and care coordination may contribute to…

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Editor's Note The US Food and Drug Administration (FDA) designated Getinge’s recall of Vaporizer Sevoflurane Maquet Filling and Sevoflurane Quick-Fil and Philips’ recall of Tack Endovascular Systems as Class 1s, the most severe category indicating serious risk of injury or death. The Getinge recall is an expansion of a 2024…

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Editor's Note Preliminary research shows removing breasts or ovaries can significantly improve survival and reduce recurrence risk in young breast cancer patients with BRCA mutations, HealthDay reported December 13. The findings were presented this week at the San Antonio Breast Cancer Symposium. According to the article, researchers analyzed data from…

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Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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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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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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