Tag: Safety

Report: AI, third-party risks open gaps in healthcare cybersecurity

Editor's Note Serious cybersecurity vulnerabilities remain in healthcare despite significant improvements in recent years, according to a July 16 MedCity News report on recent data from cybersecurity firm Fortified Health Security. Fortified’s research, which reportedly draws on NIST CSF data and first–hand experience from the field, assesses the state of…

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By: Matt Danford
July 23, 2025
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FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators

Editor's Note The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death. As detailed in a July 22 FDA announcement,…

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By: Matt Danford
July 22, 2025
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AI tools monitor, reduce OR infection risks

Editor's Note AI-enabled sensors, smart surveillance systems, and predictive analytics are advancing perioperative workflows while helping prevent breaches that can lead to surgical site infections (SSIs). This is the primary takeaway of a July 15 Q&A with Herman DeBoard, PhD, CEO of Huvr Inc., in Infection Control Today. As detailed…

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By: Matt Danford
July 22, 2025
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Hospitals pioneer methods to overcome DCD barriers, expand lifesaving transplants

Editor's Note Surgeons at Duke and Vanderbilt universities have devised simpler methods to retrieve donor hearts after circulatory death, according to a July 16 report from the Associated Press (AP). The research, published in the New England Journal of Medicine, details successful heart transplants using organs from donors whose hearts…

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By: Matt Danford
July 22, 2025
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FDA designates Class I recall for manual resuscitator

Editor's Note The US Food and Drug Administration has designated SunMed Holdings, LLC’s recall of the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing as Class I, the most severe category indicating serious risk of injury or death. The recall is due…

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By: Matt Danford
July 21, 2025
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FDA clears handheld robotic system for ultrasound-guided needle procedures

Editor's Note Mendaera has received US Food and Drug Administration (FDA) clearance for its Focalist system, a compact robotic device that aims to improve precision in ultrasound-guided needle-based procedures. Fierce Biotech reported the news July 9. As detailed in the article, Focalist device is intended to assist with a range…

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By: Matt Danford
July 21, 2025
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Preoperative, postoperative GLP-1s improve weight loss in bariatric surgery patients

Editor's Note Research shows using GLP-1 receptor agonists both before and after bariatric surgery is associated with greater total weight loss than surgery alone, according to a July 13 article in MedPage Today. The article focuses on a retrospective analysis of 568 patients presented at ENDO 2025, the annual meeting…

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By: Matt Danford
July 18, 2025
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FDA issues early alert for microbore extension sets

Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…

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By: Matt Danford
July 18, 2025
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FDA designates Class 1 recall for cranial drill

Editor's Note The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death. As detailed in the agency’s July 16 announcement, the recall of the single-use cranial…

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By: Matt Danford
July 17, 2025
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Rehab hospitals face scrutiny over safety, profits

Editor's Note Although for-profit rehab hospitals have become highly profitable, a recent KFF Health News report highlights serious safety violations, including patient deaths due to carbon monoxide poisoning, medication errors, and falls.  Published July 15, the article delves into recent data and inspections of these facilities, particularly those run by…

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By: Matt Danford
July 17, 2025
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