Bulletin 19-2

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FDA Announced Changes to CDC's ZIKV Blood and Tissue Safety Webpage and World Map

On March 1, 2019, the FDA announced that the Centers for Disease Control and Prevention (CDC) has changed information on its Blood and Tissue Safety webpage used to communicate epidemiological information about Zika virus (ZIKV) to the blood and tissue collection community. The webpage includes a world map of areas with risk of Zika for countries and territories outside of U.S. states. A new process has been developed to indicate risk for these areas that assigns one of four categories. Areas on the map are then shaded with a specific color based on their category:

  • Country or territory with current Zika outbreak (Red)
  • Country or territory with any prior or current reports of mosquito-borne Zika transmission (Purple)
  • Country or territory with the vector and no reported mosquito-borne Zika transmission (Yellow)
  • Country or territory with no mosquitoes that spread Zika (Green)

For the purpose of screening donors of HCT/Ps, establishments should continue to use the FDA Guidance for Industry titled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (updated May 2018).  Residence in or travel to an area with increased risk of ZIKV transmission within the past 6 months, and sex within the past 6 months with a person known to reside in or travel to an area with increased risk of ZIKV transmission, are considered ZIKV risk factors for the purpose of determining eligibility of living donors of HCT/Ps.​

FDA considers countries and territories outside the U.S. states categorized as “Red” or “Purple” as areas with increased risk of ZIKV transmission. 


Tissue banks should use the following links for additional information: 

The information can also be reached from:

 
Please contact Roman Hitchev at hitchevr@aatb.org if you have any questions or concerns.