FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks
Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…
Study finds overweight older adults have lower postsurgical mortality than peers with normal BMI
Editor's Note Older adults with a body mass index (BMI) in the overweight range had significantly lower odds of death after major elective surgery compared with those in the normal BMI category, an August 26 study published by JAMA Network reports. The cohort study followed 414 adults aged 65 years…
FDA posts four device safety communications, prompting inventory, workflow checks
Editor's Note The Food and Drug Administration (FDA) has issued four medical device recalls and early alerts between September 23 and 30, covering Automated Impella Controllers, Olympus ViziShot 2 FLEX (19G) endoscopic aspiration needles, 3M Ranger blood and irrigation fluid warming systems, and BD Alaris infusion pump sets. The notices…
Nutrition screening tool predicts poor outcomes after pancreatic cancer surgery
Editor's Note The Perioperative Nutrition Screen (PONS) identifies patients at greater risk of complications following pancreatic cancer surgery, according to a retrospective analysis published August 27 by Research Square. The study found that patients flagged for nutrition risk by PONS experienced longer hospital stays, higher complication rates, and were more…
Fall deaths among older adults have tripled, prescription drugs under scrutiny
Editor's Note Deaths from falls among Americans over 65 have more than tripled in the past 3 decades, raising alarm among geriatric experts and fueling debate about the role of prescription drugs, HealthLeaders September 15 reports. The Centers for Disease Control and Prevention (CDC) recorded more than 41,000 fall-related deaths…
Study identifies risk factors for PE and DVT after ambulatory surgery
Editor's Note Pulmonary embolism (PE) and deep vein thrombosis (DVT) are rare after same-day surgeries, but when they occur, they carry high risks of death and readmission. According to Anesthesiology News May 12, a University of Texas Southwestern Medical Center analysis of more than 1.1 million outpatient procedures found an…
Endoscopy case highlights risks of complex patients in ASCs
Editor's Note A malpractice case involving a 69-year-old man undergoing an endoscopy at an ambulatory surgery center (ASC) spotlights the risks of managing high-comorbidity patients outside a hospital setting. According to a May 13 report in Anesthesiology News, the patient experienced a hypoxic event that led to permanent brain injury…
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…
FDA designates Class I recall for disposable surgical stapler cartridge correction
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…
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…
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