REGULATORY UPDATE: Zika Virus No Longer a Relevant Communicable Disease for HCT/P Donation

The Food and Drug Administration announced Monday that the agency no longer considers Zika virus (ZIKV) to be a relevant communicable disease agent or disease (RCDAD) for human cells, tissues, and cellular and tissue-based product (HCT/P) donation. As a result, the agency is withdrawing its May 2018 guidance on screening HCT/P donors for ZIKV infection. HCT/P establishments can now stop screening donors for ZIKV and update their procedures accordingly.

AABB supports FDA’s decision to update donor eligibility criteria based on evidence that ZIKV no longer has “sufficient incidence or prevalence to impact the potential HCT/P donor population,” as defined by FDA regulations (21 CFR 1271.3[r][2]). The agency will continue to monitor ZIKV trends both in the United States and globally. If the epidemiology changes and ZIKV once again has sufficient incidence and/or prevalence to affect the potential HCT/P donor population, FDA may reinstate its classification as an RCDAD and issue guidance with recommendations to reduce the risk of transmission of ZIKV by HCT/Ps.

Following the FDA announcement, AABB is now in the process of developing a toolkit that outlines implementation options for facilities that collect HCT/Ps. Implementation can be immediate or based on the facility’s timeline for completion of operational changes. These options include the following:

1. Updating the computer system and discontinuing screening donors with the Zika “Additional Questions.”
2. Continuing to ask the Zika “Additional Questions” without deferring the donor. This strategy may serve as an interim strategy until HPC questionnaires and computer systems are updated.
3. Continuing to ask the Zika “Additional Questions” and continuing to defer the donor until HPC questionnaires and computer systems are updated.