Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
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…
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…
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…
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…
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…
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…
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,…
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…
Editor's Note Mendaera has received US Food and Drug Administration (FDA) clearance for its Focalist system, a compact robotic device that aims to improve precision in ultrasound-guided needle-based procedures. Fierce Biotech reported the news July 9. As detailed in the article, Focalist device is intended to assist with a range…