Tag: Rules and Regulations

Dissolution of CDC infection control panel raises concern over stagnant guidelines

Editor's Note The Trump administration has dismantled the federal committee responsible for shaping national infection prevention standards in hospitals, sparking concern among healthcare experts over future preparedness, NBC News reported May 6. According to the article, the Centers for Disease Control and Prevention (CDC) informed members of the Healthcare Infection…

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By: Matt Danford
May 7, 2025
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Time for a surgical skills check? Inside the ACS stance on aging physicians

Takeaways • US surgeons have no mandated retirement age. According to the Aging Surgeon Program, “a patient death or serious negative event are currently the only things that prompt action to prevent a surgeon from practicing.” • Research on aging-related decline is clear, but nuanced, showing rates and scope vary…

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By: Brita Belli
May 7, 2025
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State AGs sue HHS over sweeping cuts

Editor's Note State attorneys general from 20 states filed suit to block major restructuring and layoffs at the Department of Health and Human Services (HHS), alleging the actions bypass Congress, violate federal law, and endanger public health. As detailed in a May 5 report from Fierce Healthcare, the lawsuit seeks…

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By: Matt Danford
May 6, 2025
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ASCA 2025: Leading lawmaker reflects on surgery center priorities

Editor's Note At the 2025 Ambulatory Surgery Center Association (ASCA) conference, discussion of legislative priorities extended beyond educational sessions. Thanks to a visit from the ranking lawmaker of the congressional subcommittee responsible for most healthcare policymaking, attendees also got first-hand insight into the latest negotiations on Capitol Hill. US Representative…

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By: Matt Danford
May 6, 2025
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ASCA 2025: Flexibility, foresight prevent costly ASC design mistakes

Editor's Note A thoughtful, operations-driven approach to ambulatory surgery center (ASC) facility design can prevent major delays, costly change orders, and inefficient workflows down the line, according to a May 2 presentation from Akshay Tavkar, MBA, CMPE, CASC, principal and managing director of Skyline Healthcare Solutions, LLC, at the Ambulatory…

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By: Matt Danford
May 6, 2025
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Power loss risks prompt FDA Class 1 recall designation for heart pump accessories

Editor's Note Sudden, unexpected shutdown and restart prompted the US Food and Drug Administration (FDA) to designate a class 1 recall—the most severe category reserved for serious risk of injury or death—for Abbot’s HeartMate Mobile Power Unit, which powers system controllers for the HeartMate 3 Left Ventricular Assist System (LVAS)…

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By: Matt Danford
April 25, 2025
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FDA issues Class 1 recall for vascular cannulas

Editor's Note Aortic root cannulas from Medtronic are the subject of the latest US Food and Drug Administration (FDA) class 1 recall, the most serious category reserved for risk of injury or death. Affected products include the DLP Aortic Root Cannula, MiAR Cannula, and DLP Aortic Root Cannula with Vent…

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By: Matt Danford
April 1, 2025
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Bipartisan bill would expand presidential trade authority over medical goods

Editor's Note The bipartisan Medical Supply Chain Resiliency Act would grant the president expanded authority to negotiate trade deals and modify tariffs on medical goods, according to a March 14 report from Fierce Healthcare. The bill, backed by pharmaceutical and healthcare industry groups, aims to strengthen the US medical supply…

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By: Matt Danford
March 20, 2025
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Survey: Health system CEOs prioritize regulation, workforce, technology investments

Editor's Note Health system executives cite regulatory uncertainty, workforce challenges, and technology investment as top priorities for the next five years, according survey data released February 26 by healthcare advisory firm Chartis. Based on responses from 61 US health system CEOs and chief security officers (CSOs) in December 2024, the…

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By: Matt Danford
March 13, 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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