Yesterday, the Center for Biologics Evaluation & Research (CBER) at the Food and Drug Administration (FDA) posted new guidance regarding screening donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for evidence of, and risk factors for, infection with Zika Virus (ZIKV). These recommendations are designated for immediate implementation and this is further described as an expectation to implement these measures as soon as feasible, but not later than 4 weeks after the guidance issue date (by March 29, 2016). Access the guidance at:
Posted: 3/1/2016
Some relevant points from the guidance:
- ZIKV is identified as a relevant communicable disease agent or disease (RCDAD) as defined in 21 CFR Part 1271 and, as such, the guidance supplements the recommendations contained in the "HCT/P Donor Eligibility" final guidance dated August 2007;
- excellent ZIKV epidemiology and public health impact information is provided and should be saved as a reference and used when screening donors;
- current knowledge regarding the potential for transmission of ZIKV by HCT/Ps and persistence of the virus in cells and tissues is described;
- a donor antibody screening test for ZIKV is not currently available;
- the review of relevant medical records, as defined in 21 CFR 1271.3(s), is important and must indicate that a potential donor of HCT/Ps is free from risk factors for, or clinical evidence of, ZIKV infection;
- obtaining relevant travel history may be important; and
- regarding potential risk of transmission by HCT/Ps, a distinction is made between living donors and deceased donors, and specific recommendations are provided below.
Recommendations for Living Donors of HCT/Ps
Living donors of HCT/Ps should be considered ineligible if they have any of the following risk factors:
1. Medical diagnosis of ZIKV infection in the past 6 months.
3. Sex within the past 6 months with a male who is known to have either of the risk factors listed in items 1 or 2, above.
Additionally, donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if the birth mother who seeks to donate gestational tissues has any of the following risk factors:
4. Medical diagnosis of ZIKV infection at any point during that pregnancy.
6. Sex at any point during that pregnancy with a male who is known to have either of the risk factors listed in items 1 or 2, above.
Note: Limited instances for which use of HCT/Ps recovered from an ineligible donor is not prohibited, or in which a DE determination is not required, are described in 21 CFR 1271.65(b) and 21 CFR 1271.90, respectively.
Recommendations for Non-Heart-Beating (Deceased) Donors of HCT/Ps
The following non-heart-beating (deceased) donors should be considered ineligible:
- Persons with a medical diagnosis of ZIKV infection in the past 6 months.
When FDA/CBER guidance is issued, comments to CBER may be submitted. The AATB is collecting comments; send them to
Scott Brubaker. Be aware that, as knowledge is acquired, guidance can change for reducing the risk of transmission of ZIKV by HCT/Ps.
The AATB's Tissue Transmitted Diseases Advisory Group (TTDAG), a sub group of the Physicians' Council, will reconvene to discuss this guidance. Regarding the Uniform Donor Risk Assessment Interview (UDRAI) forms and flowcharts, the UDRAI Stakeholder Review Group will also convene to address any changes indicated for the UDRAI tools and if creation of a new addendum is appropriate. The work of these groups will be completed as soon as possible and before the end of this month.
The
Zika Virus website of the Centers for Disease Control and Prevention can be bookmarked as a reference.
