FDA Publishes Donor Screening Recommendations to Reduce Risk of Transmission of Zika Virus by HCT/Ps
The FDA published a final
guidance containing recommendations for establishments that make eligibility decisions for prospective donors of human cells, tissues and cellular and tissue-based products (HCT/Ps). The guidance, which supplements the August 2007 guidance, “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products,” identifies Zika virus as a relevant communicable disease agent or disease and is meant for immediate implementation. It highlights the potential risk of transmission of Zika virus by HCT/Ps, including hematopoietic stem or progenitor cells from cord and peripheral blood, corneas, bone, skin and heart valves. FDA recommends completing a medical record review for all prospective donors to confirm that they are free from risk factors for, or clinical evidence of, Zika virus infection. Risk factors include — within the past six months — a medical diagnosis of Zika virus infection; residence in, or travel to, an area with active Zika virus transmission; or sexual relations with a male who meets either of these risk factors. The recommendations are different for living and cadaveric donors of HCT/Ps. FDA recommends implementation as soon as feasible but no later than four weeks after the issue date.