Rules and Regulations
Certification options abound for infection preventionists
Patient safety and regulatory compliance demand thoroughly vetting those tasked with preventing healthcare-associated infections. But which certification is the right fit? Those who are new to infection control have a wide range of options for verifying their newly acquired expertise. More seasoned infection preventionists (IPs) also have a number of…
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…
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…
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)…
FDA issues early alerts for intravascular catheters
Editor's Note The US Food and Drug Administration (FDA) warned of safety risks resulting from manufacturing issues with two varieties of intravascular catheter—Conavi Medical’s Novasight Hybrid line and BD’s PowerPICC intravascular devices—in separate early alerts April 18. In one reported incident, the sheath of a Novasight Hybrid catheter—a device used…
Health system mega-mergers fall short amid cost, quality concerns
Editor's Note Chasing size through mega-mergers no longer guarantees sustainability for health systems, according to an April 15 article in HealthLeaders. Many of the nation’s largest systems are reporting significant losses, while emerging evidence links consolidation to stagnant or declining care quality and worsening workforce challenges. The article highlights financial…
CMS vision shifts as agency halts funding for state programs
Editor's Note The Centers for Medicare & Medicaid Services (CMS) will no longer approve federal matching funds for designated state health programs (DSHPs) and designated state investment programs (DSIPs) that are not directly related to Medicaid services. According to the April 10 announcement, the decision aims to preserve the core…
GAO urges HHS to improve drug shortage response coordination
Editor's Note The Government Accountability Office (GAO) has called on the Department of Health and Human Services (HHS) to implement a formal mechanism for coordinating efforts to address ongoing drug shortages, which continue to jeopardize patient care nationwide. In a report released April 9, 2025, the GAO highlighted the critical…
FBI investigates as Oracle health data breach exposes patient information
Editor's Note Cybercriminals breached a legacy server at Oracle Health, stealing patient data from multiple hospitals and health systems, according to a March 31 article in Healthcare Executive. The breach, discovered around February 20, occurred before Oracle migrated the affected server from Cerner's system to Oracle Cloud. According to the…
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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