FDA issues recommendations to reduce the risk of Zika virus transmission

The U.S. Food and Drug Administration  (FDA) has issued recommendations to reduce the risk of Zika virus transmission by human cell and tissue products. There is a potential risk that the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure.

The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues. The new guidance is a part of the FDA’s on-going efforts to protect HCT/Ps and blood products from Zika virus transmission.

Commenting further, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, stated: “Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues. Providing HCT/P establishments with donor eligibility recommendations will help reduce that potential risk.”

The report can be accessed here.



Posted by Dr. Tim Sandle