FDA approves single-dose propofol amid drug shortage
Editor's Note The Food and Drug Administration (FDA) approved Amneal Pharmaceuticals' Abbreviated New Drug Application for single-dose vials of propofol injectable emulsion, Anesthesiology News August 23 reports. The newly approved formulations include 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL vials. Propofol is widely used for anesthesia and…
Some FDA-recalled medical devices remain in use while manufacturers implement corrections
Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…
FDA announces Class 1 recall for chest compression devices
Editor's Note The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death. A motor issue could stop compressions in adults whose hearts suddenly stop, according to the…
Immunotherapy’s FDA approval expected to improve lung cancer treatment
Editor's Note The US Food & Drug Administration (FDA) has approved immunotherapy durvalumab for perioperative treatment of resectable non-small cell lung cancer (NSCLC), according to an August 15 announcement. The approval is for durvalumab (Imfinzi, AstraZeneca) in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by durvalumab alone as…
Battery problem prompts FDA Class 1 recall for infusion pumps
Editor's Note The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death. According to he agency’s August 20 announcement, the company is updating…
FDA warns healthcare providers to conserve blood culture media bottles amid shortage
Editor's Note Healthcare providers should consider strategies to conserve BD BACTEC blood culture media bottles for patients at highest risk due to an ongoing shortage, according to a July 10 report from The US Food and Drug Administration (FDA). Attributing the shortage to supplier issues, FDA warns that the disruption…
One expert concerned over drug shortages record high
Editor's Note Erin Fox, senior pharmacy director at University of Utah Health who has been monitoring drug shortages for over 20 years, spoke to AP News in June of her concerns. Currently, the situation is worse than ever, with total active shortages hitting an all-time high of 323 (with 48…
FDA announces Class 1 recalls for ventilators, LVAS monitors
Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…
FDA issues Class 1 recalls for two ventilator models
Editor's Note Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…
Updated ethylene oxide sterilizer standard covers latest technology
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide (EO) sterilizers for healthcare facilities, according to a June 12 press release. The first update in two decades, the fourth edition ANSI/AAMI ST24:2024 covers labeling, safety, performance, and testing requirements for general-purpose…
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