FDA: Reports of squamous cell carcinomas, lymphomas in breast implant scar tissue
Editor's Note The Food and Drug Administration (FDA) on September 8 issued a Safety Communication informing the public about reports of cancers, including squamous cell carcinomas and various lymphomas in the scar tissue that forms around breast implants. The various lymphomas are not the same as the lymphomas reported in…
FDA alerts patients, providers of Philips Respironics masks recall
Editor's Note The Food and Drug Administration (FDA) issued a safety communication alert on September 6 informing patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due…
FDA: Class I recall of Integra’s CereLink ICP Monitor
Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…
FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator
Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…
Efficacy of metformin, ivermectin, fluvoxamine for COVID-19
Editor's Note This phase 3, double-blind, randomized, placebo-controlled study led by researchers at the University of Minnesota, Minneapolis, finds that none of three medications evaluated—metformin, ivermectin, or fluvoxamine—prevented the occurrence of a primary event—hypoxemia, an emergency department (ED) visit, hospitalization, or death—associated with COVID-19. Of 1,323 patients analyzed, a primary…
FDA: Class I recall of Intera 3000 Hepatic Artery Infusion Pump
Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…
Moral distress in healthcare providers working in safety net practices during COVID-19
Editor's Note This study led by researchers at the University of North Carolina School of Medicine, Chapel Hill, finds that nearly 72% of healthcare providers in US safety net practices experienced either mild or intense levels of moral distress during the first year of COVID-19 because of issues with patient…
Effect of aspirin vs enoxaparin on VTE after total hip, knee arthroplasty
Editor's Note This study (CRISTAL randomized trial) from Australia finds that aspirin compared with enoxaparin resulted in significantly higher rates of venous thromboembolism (VTE) after total hip or knee arthroplasty. This cluster-randomized, crossover trial included 9,711 patients in 31 hospitals in Australia—5,675 in the aspirin group and 4,036 in the…
FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries
Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…
Regular physical activity linked to lower risk of COVID-19 infection, adverse outcomes
Editor's Note This meta-analysis led by researchers in Spain finds that regular physical activity is associated with a lower risk of COVID-19 infection, severity, and mortality. The analysis included 1,853,610 adults from multiple countries worldwide—54% were women, and the average age was 53. Compared with physically inactive individuals, those who…
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