Tag: medical devices

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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Session: Crew Incentives: 3 Guiding Principles to Leverage Value Analysis Teams

Editor's Note Jasmine Hampton-Nicholson MSN, RN, CNOR, learned the value of a value analysis team (VAT) the hard way. “I thought that we had a very solid process for our value analysis team,” said the VP of perioperative services at Temple University Health System in a presentation at 2025 OR…

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By: Matt Danford
February 12, 2025
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FDA announces Class 1 recall for ventilator system

Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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By: Matt Danford
February 6, 2025
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Surgeons risk losing ground as transcatheter tricuspid valve interventions rise

Editor’s Note At the Society of Thoracic Surgeons (STS) annual meeting, experts urged cardiac surgeons to become more engaged in tricuspid valve treatment before transcatheter options gain too much traction according to a January 26 report in MedPage Today. With new transcatheter devices gaining FDA approval and the Centers for…

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By: Matt Danford
January 29, 2025
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Health systems embrace multi-year medical technology partnerships

Editor’s Note Healthcare systems are increasingly establishing long-term collaborations with medical technology companies with the goal of modernizing technology and streamlining operations through ongoing training and consultation services. Modern Healthcare reported the news January 24. Involving substantial financial investments, these collaborations redefine vendor relationships as more strategic and relational, the…

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By: Matt Danford
January 28, 2025
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