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Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World

Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World

February 28, 2019

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 other 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, and the area is shaded with a specific color:

  • 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 Food and Drug Administration (FDA), Center for Biologics Evaluation and Research’s (CBER’s) 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, and sex 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. 

Note: The table that lists areas where ZIKV transmission was previously reported, but that were later classified as having interrupted transmission, has been removed from the CDC webpage but remains available for historical purposes (see link below). As of today, each of the areas with interrupted transmission was returned to purple shading on the updated world map.

Areas of increased risk of ZIKV transmission in U.S. states will continue to be defined at the county level within a state, including risk start and end dates, as listed on the CDC webpage for Blood and Tissue Safety.

Regarding references to use when screening living donors of HCT/Ps:

  • First access the CDC webpage for Blood and Tissue Safety.
  • To evaluate domestic travel, the “Areas at increased risk for Zika virus transmission through blood or tissue donation in U.S. states” is listed first and continues to be defined at the county level within a state. For the purpose of screening HCT/P donors, do not use other CDC webpages or maps for evaluating travel within the United States.
  • For evaluating travel to areas outside of the U.S. states, use the link to the world map and consider countries and territories categorized as “Red”or “Purple” as areas with increased risk of ZIKV transmission.  When an area outside the U.S. states becomes shaded as Red or Purple for the first time on the world map, that area and the date of the change will be posted on the Blood and Tissue Safety webpage. 
  • The CDC webpage for Blood and Tissue Safety should be monitored frequently for any updates.

Considerations for HCT/Ps Recovered Prior to Posting this Announcement
HCT/Ps recovered prior to posting this announcement (i.e., prior to the change to CDC’s Blood and Tissue Safety webpage) should have been screened for travel to other countries and territories using previous maps and tables. The tables have been archived for historical purposes only. See link: Archived Tables - Other Countries and Territories.