FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks
Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…
Considerations for external transportation of processed medical devices
The centralization of medical device processing to one facility is becoming more prevalent. Centralizing sterile processing activities reduces expenses while concentrating expertise. However, this also introduces new concerns. When sterile processing is located within the same building where instrumentation is used, transport occurs over smooth floors in a controlled environment…
US launches tariff investigations into medical supplies and devices, raising stakes for healthcare supply chain
Editor's Note The US Department of Commerce has initiated national security investigations that could trigger new tariffs on a wide range of imported medical products, with potentially far-reaching effects for healthcare providers, Reuters September 24 reports. The probes, opened under Section 232 of the Trade Expansion Act of 1962, cover…
ACS conference charts bold future for surgical quality with data, teamwork, frontline innovation
Editor's Note Surgical quality leaders are pushing boundaries with new strategies that blend technology, frontline engagement, and national-local collaboration. That was the message from the American College of Surgeons (ACS) Quality and Safety Conference (QSC), held July 17–20, 2025, in San Diego, according to a September 10 ACS report. The…
Surgical leaders urged to weigh risks, rewards of innovation with a critical eye
Editor's Note Innovation is transforming surgical care faster than most institutions can keep pace, but leaders must distinguish between investments that advance patient care and those that add cost without meaningful benefit. That is the central message from a September 8 Harvard Medical School article featuring insights from Jon O.…
Surgical innovation redefines what is possible for advanced colorectal cancer
Editor's Note Colorectal tumors once considered inoperable are now routinely treated with curative surgery, thanks to advances in multimodality therapy and complex resection techniques, Mayo Clinic September 16 reports. Decades ago, cancers invading the sacrum, pelvic organs, or major blood vessels were often deemed unresectable, leaving patients with only palliative…
AMA 2026 CPT code set expands with AI, remote monitoring, leg revascularization updates
Editor's Note The American Medical Association (AMA) has released the 2026 Current Procedural Terminology (CPT) code set, introducing 288 new codes that capture emerging technologies and modern care delivery models, the association announced on September 11. In total, the update includes 418 changes: 84 deletions, 46 revisions, and the newly…
Surgical patients see better outcomes but face longer hospital stays, AHA and Vizient report finds
Editor's Note Hospitalized surgical patients in 2024 were nearly 20% more likely to survive than expected compared to 2019, according to an August 5 analysis from the American Hospital Association (AHA) and Vizient. The report credits safety improvements such as reductions in infections, falls, and major complications, even as surgical…
FDA flags device recalls while clearing new technologies for surgery, critical care
Editor's Note The Food and Drug Administration (FDA) has issued multiple high-risk medical device recalls in recent weeks, mid-September FDA announcements report. On August 21, Medline alerted customers that some of its convenience kits contain recalled Medtronic DLP Left Heart Vent Catheters. These catheters, used in cardiopulmonary bypass, may fail…
From checklists to culture: Practical steps for leaders to strengthen OR safety
The OR has a planned rhythm that relies on training, checklists, and teamwork to turn the complex surgical environment into an elegant orchestration that keeps patients safe. But efficiency and a climate of safety do not just happen—they depend on culture. When teams communicate openly, follow standards consistently, and feel…
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