11/12 October 2022
On 1 March, the Food and Drug Administration's Center for Biologics Evaluation and Research (FDA CBER) published a new guidance document entitled "Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products." Related to the current situation with this virus, the FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). As the authority determined that prior public participation is not feasible or appropriate, this guidance was issued without seeking prior comments.
The guideline is made for establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). It contains recommendations for screening donors for evidence of and risk factors for infection with the Zika virus (ZIKV). It supplements the Guidance for Industry “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”.
Currently, scientist have the suspicion, that the virus will cause microcephaly of babies if the mother is infected during her pregnancy. Additionally the infection may also be associated with neurologic manifestations, including Guillain-Barré syndrome, although a direct connection has yet to be confirmed.
The virus has been known since 1947 and can be isolated out of blood, sperm and urine of infected patients. Currently a transmission by blood or solid organ transfusion/transplantation has not been conclusively documented, but there are two cases in Brazil and French Polynesia with a substantiated suspicion of a blood related transmission. Furthermore, the Virus was detected in brain, liver, kidney and further organs and tissues but there are no data available, whether it can be still infectious in the case of transplantation of such organs.
Generally, there is a theoretical risk of transmission by transfusion or transplantation materials."Therefore, review of relevant medical records, as defined in 21 CFR 1271.3(s), must indicate that a potential donor of HCT/Ps is free from risk factors for, or clinical evidence of, ZIKV infection for the purpose of determining donor eligibility." With the guideline" Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products" the FDA provides the affected establishment with necessary recommendations to fulfil these requirements.