Tag: Patient Safety

FDA designates Class I recall for neurosurgery software

Editor's Note The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death. The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during…

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By: Matt Danford
June 5, 2024
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The Joint Commission proposes revisions to IC requirements for office-based surgery, ambulatory healthcare programs

Editor's Note The Joint Commission is set to revise the Infection Prevention and Control (IC) chapter requirements for both office-based surgery (OBS) practices and ambulatory healthcare (AHC) organizations, effective July 1, 2025. These revisions aim to streamline the IC chapter, focusing on essential structures and processes that support quality and…

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By: Tarsilla Moura
June 5, 2024
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Dialysis patients feasible for kidney donation, transplant outcome study suggests

Editor's Note A retrospective cohort study found transplanting kidneys from donors who underwent dialysis resulted in no long-term differences in graft failure, kidney function, or death, but recipients had significantly higher risk for delayed graft function (DGF). According to a May 23 MedPage Today report on the study, originally published…

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By: Matt Danford
June 3, 2024
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Study: Preoperative weight loss offers little benefit for bariatric surgery patients

Editor's Note Research shows perioperative weight loss does not consistently improve outcomes or OR times in patients undergoing primary bariatric procedures, including laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (RYGB). The findings were published in the June issue of the Journal of the American College of Surgeons. Using…

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By: Matt Danford
June 3, 2024
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HHS: Change Healthcare responsible for cyberattack data breach notifications

Editor's Note Change Healthcare is responsible for notifying affected parties about privacy breaches resulting from the February cyberattack on the company, The U.S. Department of Health and Human Services (HHS) announced May 31. The announcement took the form of an update to an FAQ webpage from HHS’ Office for Civil…

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By: Matt Danford
June 3, 2024
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Type 2 diabetes case cured via stem cell therapy, researchers report

Editor's Note Researchers claim a stem cell transplant cured type 2 diabetes in a 59-year-old man who previously needed multiple daily insulin injections, the South China Morning Post reported May 27. The Chinese researchers behind the reported breakthrough published details of the case April 30 in the journal Cell Discovery.…

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By: Matt Danford
May 31, 2024
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Class 1 recall announced for ambulatory infusion pump

Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…

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By: Matt Danford
May 31, 2024
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Florida allows C-sections outside hospitals amid controversy over safety, cost

Editor's Note Florida became the first US state to permit doctors to perform cesarean sections (C-sections) outside hospitals, siding with a private equity-owned physicians group advocating for cost reduction and a homier birthing environment, KFF Health News and HealthLeaders May 28 reports. However, the hospital industry and the American College…

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By: Tarsilla Moura
May 29, 2024
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Surgery benefits transplant-ineligible HCC patients more than less invasive options

Editor's Note Liver resection provides a significant survival benefit over percutaneous radiofrequency ablation (PRFA) or transarterial chemoembolization (TACE) in patients with early multinodular hepatocellular carcinoma (HCC), according to findings published May 15 in JAMA Surgery. Thus, liver resection should be considered the first therapeutic option in patients with early multinodular…

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By: Matt Danford
May 29, 2024
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Colorado passes first state-level AI regulations

Editor's Note Colorado is the first state in naton to pass legislation regulating the use of artificial intelligence (AI) in pivotal decision-making, including in healthcare, according to a May 22 report in Politico. The new law has sparked significant debate, according to the report, with some viewing it as a…

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By: Matt Danford
May 29, 2024
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