Regulations/Legal

Latest Issue of OR Manager
March 2025
Home Regulations/Legal

FDA designates Class 1 recall for embolization devices

Editor's Note Endovascular devices used to block aneurysm blood flow are the subject of the latest recall to be designated Class 1—the most severe designation indicating serious risk of injury or death—by the US Food and Drug Administration (FDA). As detailed in the agency’s March 18 announcement, Medtronic Neurovascular is…

Read More

By: Matt Danford
March 19, 2025
Share

AI reshapes healthcare leadership

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…

Read More

By: Matt Danford
March 19, 2025
Share

States seek restraints on healthcare private equity

Editor's Note Multiple states seek to limit corporate influence in medicine by instituting additional checks on private equity-driven healthcare mergers, according to a March 17 report in Axios. Referencing multiple state-specific reports, the article summarizes specific efforts in Massachusetts, where a new law expands oversight of transactions; Maine, where a…

Read More

By: Matt Danford
March 17, 2025
Share

GLP-1 drugs reshape surgery demand, threaten hospital revenue

Editor's Note The widespread adoption of GLP-1 weight-loss medications like Ozempic and Wegovy could put revenue at risk across multiple service lines, according to a March 11 article in Becker’s Hospital Review. As a result, hospitals and ambulatory surgery centers (ASCs) face critical questions about how to adapt. The article…

Read More

By: Matt Danford
March 14, 2025
Share

Sponsored Message

UnitedHealth’s dominant growth forges ahead amid intensifying antitrust scrutiny

Editor's Note In addition to the uptick in acquiring outpatient facilities since 2023, UnitedHealth Group quietly acquired or created more than 250 subsidiaries last year, expanding its already vast network of services comprising a major health insurer, physician practices, a pharmacy benefit manager, and various other healthcare ventures, STAT March…

Read More

By: Tarsilla Moura
March 12, 2025
Share

Analysis: How the new US malpractice standard puts evidence-based ‘reasonable care’ over customary practice

Editor's Note A February 26 letter in JAMA Network reported a revised legal standard for medical negligence in the US, shifting from traditional reliance on customary practice toward a more patient-centered, evidence-based definition of “reasonable care.” The American Law Institute (ALI) updated its framework in 2024, retaining elements of prevailing…

Read More

By: Tarsilla Moura
March 12, 2025
Share

Sponsored Message

Supreme Court case could threaten colorectal cancer screening access, ACG warns

Editor's Note The American College of Gastroenterology (ACG) is warning that millions of Americans could lose access to essential colorectal cancer (CRC) screenings if the Supreme Court rules against the role of the US Preventive Services Task Force (USPSTF) in guiding preventive care coverage. According to the organization’s March 7…

Read More

By: Matt Danford
March 12, 2025
Share

Study: Implicit bias linked to low-value vascular procedures, worse outcomes for Black patients

Editor's Note Reducing the negative influence of implicit bias requires system-level interventions to ensure procedures align with best practices for all patients, according to results of new research on outcomes for vascular surgery patients. Published February 26 in JAMA Surgery, the study showed that implicit racial bias among vascular specialists…

Read More

By: Matt Danford
March 11, 2025
Share

New legal standard redefines medical negligence

JAMA (healthcare publication) Network logo

Editor's Note A revised legal standard for assessing medical negligence in the US shifts away from customary medical practice and toward a more patient-centered definition of reasonable care, according to a February 26 letter published in Jama Network. Following a 2024 update from the American Law Institute, the new framework…

Read More

By: Matt Danford
March 7, 2025
Share

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…

Read More

By: Matt Danford
March 5, 2025
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat