Rules and Regulations

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March 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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Fresh tools, talking points drive sharps safety culture shift

Takeaways • The prevalence of needlesticks and other sharp object injuries to OR team members is 42.8%, an increase of 16% over the past decade. • New research and perspectives are shaping the discourse around sharps safety, such as new and expanded evidence-based practices presented in AORN’s 2025 update to…

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By: Carina Stanton
March 5, 2025
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Smart segregation, storage reduce biohazardous waste risks

From sharps and blood-soaked surgical instruments to discarded anesthetic agents, biohazardous waste from ORs can threaten human health and the environment. In addition, failure to adhere to regulatory requirements can result in significant fines. However, the volume and diversity of biohazardous waste can create challenges with managing this material. Mitigating…

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By: Arman Zeytounyan
March 5, 2025
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Visual cues, education boost hand hygiene compliance

It is often said that small actions lead to big results. This so happens to be the case with hand hygiene compliance (HHC) in healthcare. Imagine a simple act, like washing hands, cutting infection rates by half—hospital-acquired infections (HAIs) and surgical site infections being reduced simply by improving handwashing behaviors.…

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By: Fayoke Fatade, DNP, MSN, RN, NEA-BC
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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Cost-shifting concerns rise as GOP eyes Medicaid cuts

Editor's Note Large employers are warning hospitals they will not absorb higher costs if plans by Republicans and the Trump administration for deep Medicaid cuts proceed, a February 28 article in Modern Healthcare reports. The threat of reduced Medicaid funding has reignited concerns about hospitals shifting costs onto employers and…

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By: Matt Danford
March 3, 2025
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Trump signs executive order to enforce hospital price transparency rules

Editor's Note President Donald Trump signed an executive order to enforce healthcare price transparency regulations, according to a February 25 report in Fierce Healthcare. As detailed in the article, the order directs the Departments of Treasury, Labor, and Health and Human Services (HHS) to rapidly implement and enforce price transparency…

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By: Matt Danford
February 26, 2025
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Providence Health strike ends with wage increases, staffing changes

Editor's Note Nearly 5,000 healthcare workers at Providence Health in Oregon secured substantial wage increases and improved staffing plans, ending a historic six-week strike that began January 10, according to a February 25 article in MedPage Today. According to the article, the strike involved eight RN bargaining units and marked…

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By: Matt Danford
February 26, 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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