On February 16, 2016, FDA published a guidance document that provided blood establishments with recommendations to reduce the risk of contaminating the US blood supply with the Zika virus. On Friday, August 26th the FDA revised this guidance, stating that all blood and blood components that are donated in the US should be tested for the Zika virus.
When the FDA issued its original guidance, its contents only applied to areas with active Zika transmission. As such, all areas in the US with active transmission are currently in compliance with this guidance. However, as a further safety measure against the Zika outbreak, the Agency is now recommending “that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.”
FDA notes that it published this update after carefully considering all available scientific evidence, consulting with other public health agencies, and considering the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. All blood donated in in Florida, Puerto Rico, and other areas is already undergoing such testing. This testing has proven to be helpful in identifying donations infected with the Zika virus. FDA feels that “expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.”
For additional information on FDA’s recommendations, view the Agency’s full guidance document as well as the related news release.