Understanding nurse responsibilities in managing postoperative agitation, delirium
Editor's Note A recent article in AORN Journal underscores the need for vigilance and thorough documentation to manage postoperative mental status changes and prevent harm to both patients and staff. As detailed in the article, cognitive disturbances such as delirium and agitation can complicate recovery after surgery. Delirium is characterized…
FDA safety alerts flag cardiac devices
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
Cosmetic surgery chains targeted in lawsuits over disfiguring injuries, deaths
Editor's Note A growing subset of cosmetic surgery chains, some backed by private equity, have been named in multiple lawsuits alleging serious patient harm, according to an August 1 article in KFF Health News. Based on a joint investigation with NBC News, the outlets reports that chains offering body-reshaping operations…
Nurse-led safety forums strengthen escalation of care protocols
Editor's Note A recent article from Cleveland Clinic details the use of confidential staff forums to address barriers to escalating patient care concerns, resulting in greater caregiver engagement and targeted improvements. Published July 25, the article describes how nursing leaders collaborated with the Cleveland Clinic Alliance for Patient and Caregiver…
FDA issues early alert for microbore extension sets
Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…
FDA designates Class 1 recall for cranial drill
Editor's Note The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death. As detailed in the agency’s July 16 announcement, the recall of the single-use cranial…
FDA designates Class 1 recalls for EVH system, infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…
FDA early alerts flag pump controllers, software
Editor's Note Recent early alerts from the US Food and Drug Administration (FDA), issued when the agency becomes aware of potentially high-risk issues, involve Abiomed’s Automated Impella Controller (AIC) and infusion pump software from Baxter. The AIC system, which is the user control interface for the Impella catheter blood pump,…
Surgeons perform first dual-organ transplant on LVAD patient
Editor's Note A Florida transplant team has performed the first-ever heart-liver transplant in a patient supported by a left ventricular assist device (LVAD), offering a potential new treatment route for those previously ineligible due to high rejection risk, CBS News reported June 21. The patient, whose antibody levels placed her…
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