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 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 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 Nurse staffing rates in hospitals serving a high percentage of Black patients are worse than in hospitals serving fewer Black patients, a disparity that has significant implications for patient outcomes, according to a study from the University of Pennsylvania School of Nursing. Published in the journal Nursing Research…

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Editor's Note Black patients are less likely to receive surgery at hospitals with the lowest mortality rates despite living closer to these facilities, according to a new study examining Medicare patients undergoing coronary artery bypass grafting (CABG) from 2017 to 2019. Authors suggest that physician referral patterns may play a…

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Editor's Note Findings from The ARRC II study show using advanced recovery room care (ARRC) for medium-risk surgical patients significantly reduces 18-month postoperative mortality compared to standard ward care. As detailed in a December 11 research letter in JAMA Surgery, this benefit appears linked to minimizing early postoperative complications, which…

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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 A study analyzing data from 124,577 suspected sepsis cases across 236 US hospitals found that antibiotic de-escalation—switching to narrower-spectrum antibiotics or stopping broad-spectrum antibiotics—occurred in less than 30% of cases but was associated with improved patient outcomes, according to December 6 report from the Center for Infectious Disease…

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