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)…
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…
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…
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…
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…
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…
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…
Editor's Note Although a recent executive order from President Donald Trump aims to make hospitals and insurers reveal negotiated prices, data inconsistencies and a lack of consumer usability continue to hinder progress, according to a March 31 article from NPR. As detailed in the report, the executive order builds on…
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…
Editor's Note Chief data officer (CDO) is a fast-growing C-suite role across the economy, with the notable exception of healthcare. The reasons why might be surprising: these roles have already been filled. Rather than growing, they are evolving. That’s the primary message of a March 4 report in Becker’s Hospital…