Tag: medical devices

Study: Pulse oximeters may misestimate oxygen saturation in darker skin tones

Editor's Note Pulse oximeters may overestimate blood oxygen levels in critically ill patients with darker skin tones, according to a March 30 article in HCP Live. The article focuses on the EquiOx study, conducted at the Zuckerberg San Francisco General Hospital between 2022 and 2024. Presented at the American College…

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By: Matt Danford
April 1, 2025
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Study: Arthroplasty implants linked to metal accumulation in cerebrospinal fluid

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Editor's Note Arthroplasty implants may release metals that accumulate in the central nervous system (CNS), potentially contributing to neurotoxic effects, according to a study published March 28 in JAMA Network Open. Researchers found that patients with large joint replacements had significantly higher levels of cobalt, chromium, titanium, niobium, and zirconium…

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By: Matt Danford
March 31, 2025
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FDA announces Class 1 recall for implantable ports

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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By: Matt Danford
March 20, 2025
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Study: Miniature pacemakers for neonates, infants perform reliably for two years

Editor's Note Miniaturized pacemakers implanted in neonates and infants have demonstrated reliable performance for up to two years, with no unexpected device failures, according to a March 11 article in Healio. The research, published in Circulation: Arrhythmia and Electrophysiology, suggests that these modified pacemakers could offer a viable alternative for…

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By: Matt Danford
March 17, 2025
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Infusion pumps deemed high-risk in FDA early alert

Editor's Note Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold, according to a March 5 early alert from the US Food and Drug Administration (FDA). The FDA notice concerns the Sigma Spectrum Infusion System…

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By: Matt Danford
March 5, 2025
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Capital funding crunch spurs creative hospital financing

Health systems are fundamentally capital intensive. They are regulated; depend on highly educated, high-cost employees; and operate under complex reimbursement structures. Investing in new technologies and infrastructure upgrades is imperative to keeping up with the latest medical advances. But what happens when capital funds are insufficient or no longer available?…

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By: Anne Wainscott-Sargent
March 5, 2025
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FDA announces Class 1 endovascular system, anesthesia system recalls

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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By: Matt Danford
March 3, 2025
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FDA designates Class 1 recall for pacemakers

Editor’s Note The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could…

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By: Matt Danford
February 24, 2025
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Chinese medical devices threaten US healthcare cybersecurity

Editor’s Note Backdoors in Chinese-made medical monitors could put patients at risk and compromise hospital networks across the US, according to security agencies quoted in a February 23 report from CNBC. The article cites the popular Contec CMS8000 patient monitor as an example. Both the US Food and Drug Administration…

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By: Matt Danford
February 24, 2025
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Study: Mechanical heart valves outperform biological for long-term survival in middle-aged patients

Editor's Note Patients aged 50 to 70 undergoing heart valve replacement may benefit from mechanical valves over biological ones, according to a new study from the University of Bristol. Healthcare-in-Europe.com reported the news February 13. As detailed in the article, short-term outcomes between the two options were similar. However, mechanical…

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By: Matt Danford
February 14, 2025
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