Fact Sheet for Healthcare Providers: Hemolung RAS (Respiratory Assist System)

Source: U.S. Food and Drug Administration (FDA). Published: 4/23/2020. This three-page fact sheet informs healthcare providers of the potential benefits and risks associated with use of a critical care lung support device called the Hemolung Respiratory Assist System (RAS). Hemolung therapy is referred to as extracorporeal carbon dioxide removal (ECCO2R), or respiratory dialysis. The FDA has made Hemolung RAS available under an Emergency Use Authorization (EUA) for treatment of lung failure in COVID-19 patients when used as an adjunct to noninvasive or invasive mechanical ventilation to reduce hypercapnia and hypercapnic acidosis, and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH, in patients suffering from acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved. (PDF)
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