FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape
Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…
Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula
Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…
FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate
Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2, Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…
Study: Simple hysterectomy survival comparable to more radical procedures in early cervical cancer
Editor's Note Simple hysterectomy provides similar long-term survival outcomes to modified radical or radical hysterectomy for patients with low-risk, early-stage cervical cancer, according to a large cohort study published May 15 in JAMA Network Open. Consistent with prior research, the findings add to the growing body of evidence supporting conservative…
Post-pandemic surge in excess US deaths exposes public health decline
Editor's Note The United States recorded more than 1.5 million excess deaths in 2022 and 2023 alone—avoidable fatalities that would not have occurred if US death rates matched those of other wealthy nations, according to a May 23 article in CIDRAP reporting on a Boston University–led study published in JAMA…
Pembrolizumab sets new standard in advanced head and neck cancer surgery, trial shows
Editor's Note According to results from a randomized trial, titled KEYNOTE-689, adding pembrolizumab (Keytruda) to surgery and standard adjuvant therapy significantly prolongs event-free survival (EFS) in patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC), MedPage Today April 28 reports. Experts are calling the findings a major…
Study: Mortality prediction models fail to recognize severe patient injuries
Editor's Note Machine learning (ML) models designed to predict patient mortality are falling short when it comes to identifying severe injuries that could lead to death, according to a March 27 report in TechTarget. The article focuses on research published in Nature Communications Medicine found that ML mortality prediction models…
Medical gaslighting tops ECRI’s 2025 patient safety threat list
Editor's Note Misdiagnosis, delayed treatment, and a breakdown of trust in healthcare can all result from time and resource constraints preventing proper engagement with patients—a concern that tops ECRI’s list of the most significant patient safety risks for 2025. As detailed in the global healthcare safety nonprofit’s March 10 announcement,…
FDA announces Class 1 endovascular system, anesthesia system recalls
Editor's Note The US Food and Drug Administration (FDA) designated Getinge’s recall of Vaporizer Sevoflurane Maquet Filling and Sevoflurane Quick-Fil and Philips’ recall of Tack Endovascular Systems as Class 1s, the most severe category indicating serious risk of injury or death. The Getinge recall is an expansion of a 2024…
Study: Perioperative pregabalin reduces risk of kidney decline compared to gabapentin
Editor's Note The first study to directly compare kidney-related adverse outcomes between perioperative use of gabapentin and pregabalin shows that the former drug carries a higher risk, Renal and Urology News reported January 21. Published in Frontiers in Medicine, the study involved a trial emulation of 1,280 propensity-matched surgical patients…
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