Regulations/Legal
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
CMS payment overhaul could cut specialist pay
Editor's Note A “quiet transformation” in how Medicare pays doctors could reduce payments for specialty care, including rates for billing codes associated with surgery, diagnostic imaging, outpatient care, pain management, and orthopedics, Modern Healthcare July 22 reports. According to the article, The Centers for Medicare and Medicaid Services (CMS) 2026…
Navigating OR construction design, compliance, approval in a booming ASC market
Editor’s Note: This page is a companion piece to the main article, Proper planning prevents OR construction, renovation cost creep. It brings together four focused updates on OR and ambulatory surgery center (ASC) construction and renovation: Regulatory shifts: The Joint Commission's updated safety and sustainability requirements for hospitals and ASCs, including new…
FDA issues safety alert for Baxter Novum IQ large volume pumps
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…
Providers call for deeper reform despite CMS proposing payment hikes in 2026
Editor's Note CMS is boosting 2026 Medicare outpatient payments by 2.4%, but provider groups warn the increase barely scratches the surface of mounting financial strain. Alongside the payment bump, the agency is proposing a two-track physician reimbursement model that ties rates to value-based care participation. While some see these moves…
Proper planning prevents OR construction, renovation cost creep
How would you describe the ideal OR? Whatever the answer, the chance to reimagine and reshape the perioperative suite can be among the most exciting projects of a perioperative leader’s career. However, OR construction and renovation also can be among the most daunting projects of a perioperative leader’s career. Just…
HHS launches organ transplant oversight initiative after patient safety failures
Editor's Note The Department of Health and Human Services (HHS) has launched a major initiative to reform the US organ transplant system following disturbing findings about organ procurement practices. Fierce Healthcare reported the news July 21. According to the article, the initiative was triggered by a directive from HHS to…
FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators
Editor's Note The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death. As detailed in a July 22 FDA announcement,…
FDA designates Class I recall for manual resuscitator
Editor's Note The US Food and Drug Administration has designated SunMed Holdings, LLC’s recall of the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing as Class I, the most severe category indicating serious risk of injury or death. The recall is due…
Free Daily News
- Suicide Prevention Month: Hospitals prepare for new The Joint Commission suicide prevention goal, effective 2026
- Survey: Perioperative leaders adapt to supply strain, staffing pressure, ASC growth
- Gait retraining eases knee osteoarthritis pain as effectively as medication, can delay knee surgery
- OR leaders must sharpen questions, partnerships as AI reshapes perioperative care
- npj Digital Surgery opens call for research on AI, robotics in the OR
- AI in the OR can sharpen skills, but humans make the lessons stick
- Endoscopy case highlights risks of complex patients in ASCs
- Robotics and AI are redefining precision in cataract surgery
- CMS plan to phase out inpatient only list sparks debate over safety for vulnerable patients
- ACS issues new best practices for managing genitourinary trauma