The Food and Drug Administration (FDA) has issued new guidance on blood transfusions for immediate implementation in order to reduce the risk of Zika virus blood transmission.
The guideline’s recommendations are split in two: for areas without active transmission and for areas with active transmission of the Zika virus. With an estimated 80% of Zika infections being asymptomatic and 2 previous possible cases of transfusion in Brazil, the risk of transmission is substantial.
In areas without active Zika virus transmission, the FDA recommends donors at risk for Zika virus infection be deferred for 4 weeks. At-risk individuals include:
- Those who have had symptoms suggestive of Zika virus infection during the past 4 weeks
- Those who have had sexual contact with a person who has traveled to, or resided in, an area with active Zika virus transmission during the prior 3 months
- Those who have traveled to areas with active transmission of Zika virus during the past 4 weeks
For areas with active Zika virus transmission (signified by the CDC), the recommendations include obtaining blood components for transfusion from areas of the U.S. without active transmission. This includes whole blood and red blood cells (RBCs), platelets and plasma. Collections may be made locally in areas of active transmission if an FDA-licensed blood donor screening test for Zika has been conducted.
In the case of an institution within an active transmission area who continue to collect blood due to having an FDA-approved pathogen reduction technology or an FDA-licensed blood donor screening test, the recommendations include updating donor education materials with Zika virus information and asking potentially affected donors to refrain from giving blood. The guidance to update educational material and questionnaires also applies to areas currently without active transmission of the virus.
Updated educational material should include details of the signs and symptoms of Zika infection, while the updated questionnaire should include a history of Zika infection, or symptoms suggestive of Zika, in the past 4 weeks. In addition, the donor questionnaire should inquire of any sexual contact with a man in the past 4 months who has been diagnosed, or shown symptoms of Zika virus. Donors can be considered eligible again after the deferred period has lapsed.
The FDA also plans to release a guidance to address appropriate donor deferral measures for human cells, tissues, and cellular and tissue-based products, in light of recent reports of sexual transmission of Zika virus.
For more information visit FDA.gov.