On August 26th, the US Food and Drug Administration issued a revised guidance to US blood banks addressing Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.
The Zika virus is transmitted primarily by the Aedes mosquito; it can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, Zika can sicken people and Zika infection during pregnancy can cause serious birth defects.
The FDA’s earlier Zika guidance related only to the specific US areas with reported active local Zika transmission (Puerto Rico, American Samoa, the US Virgin Islands, and certain localities in Florida). The FDA’s revised guidance now recommends 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. Alternatively, existing FDA-approved pathogen-reduction devices may be used for plasma and certain platelet products.
Blood banks in states or territories with one or more cases of locally transmitted Zika virus should implement the new screening policies immediately. Blood banks in neighboring states should implement the new screening policies as soon as feasible, but no later than 4 weeks after the issuance of this guidance. Blood banks in all other areas should also implement the new screening policies as soon as feasible, but no later than 12 weeks after the issuance of the guidance.
Testing of donated blood was already underway in Florida, Puerto Rico, and certain other areas, before issuance of the revised guidance. The FDA expects that expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply