New FDA Guidance to Prevent Donor-Related Zika Infection Spread
The Food and Drug Administration (FDA) has recommended certain human cell, tissues, and cellular and tissue-based products (HCT/Ps) be considered ineligible in order to halt the risk of further spreading the Zika virus.
The Agency acknowledged that based on current knowledge of similar viruses, there is a potential risk of Zika virus transmission by HCT/Ps used as part of a medical, surgical, or reproductive procedure. Such products include corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs), gestational tissues (eg, amniotic membrane), and reproductive tissues (eg, semen, oocytes).
Specifically, the Agency recommends against any potential donor who was diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of the aforementioned risk factors within the past 6 months. Umbilical cord, placenta, or other gestational tissue donors should be deemed ineligible if they have had any of the aforementioned risk factors at any point during pregnancy.
Additionally, deceased donors should be considered ineligible if they were diagnosed with Zika virus infection in the past 6 months.
The 6-month period of deferral was established as the virus is known to persist in tissue and fluids after it is undetectable in the bloodstream. Zika virus has also been detected in semen 10 weeks after symptom onset.
The latest FDA recommendations follow last month's recommendations concerning blood transfusion donors. The Agency said they will continue to monitor the situation and will carefully evaluate new information regarding the associated risks as it becomes available. The development of donor screening and diagnostic tests has been prioritized and an Emergency Use Authorization diagnostic tool is being issued to qualified laboratories.
For more information visit the FDA.gov.