FDA guidance on screening donors for Zika Virus

Authors: Yvonne K. Puig, Mark Faccenda, Wendy Wright* Publication | March 2016

On March 1, 2016, the U.S. Food and Drug Administration (FDA) issued guidance on screening donors of human cells, tissues, and cellular and tissue-based products for risk of evidence of infection with Zika virus. The FDA's guidance identifies Zika virus as a relevant communicable disease agent or disease (RCDAD) and provides recommendations for reducing the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products.

FDA regulation requires a donor-eligibility determination, based on screening and testing for RCDADs, for all donors of human cells, tissues, and cellular and tissue-based products. Such donors are eligible only if donor screening indicates that the donor is free from risk factors for and clinical evidence of infection due to RCDADs and the results of donor testing for RCDADs are negative or nonreactive.

While an FDA-licensed blood donor screening test for Zika virus is not currently available, FDA made recommendations for screening for Zika virus in living donors, birth mothers and non-heart-beating (cadaveric) donors. Living donors should be considered ineligible for donation if they have been medically diagnosed with Zika virus infection in the past six months, resided in or traveled to an area with active Zika virus transmission (as listed here by the Centers for Disease Control and Prevention) within the past six months, or had sex within the past six months with a male who is known to have either of the other two risk factors. In addition to the risk factors for living donors, birth mothers should be considered ineligible for donation of gestational tissues if they were medically diagnosed with Zika virus infection at any point during their pregnancy, resided in or traveled to an area with active Zika virus at any point during their pregnancy, or had sex at any point during their pregnancy with a male who is known to have either of the first two risk factors for living donors. Non-heart-beating (cadaveric) donors should be considered ineligible if the person had a medical diagnosis of Zika virus infection in the past six months.

FDA recommends implementing these recommendations as soon as feasible, but no later than March 29, 2016. Now that the Zika virus has been classified as an RCDAD, all licensed establishments making donor eligibility determinations should incorporate these recommendations into their standard operating procedures, as necessary.

*Wendy Wright is admitted only in North Carolina. Her practice is supervised by principals of the firm admitted in the District of Columbia.


Contacts

Mark Faccenda

Mark Faccenda

Washington, DC