On Tuesday, February 16, FDA announced the publication of a guidance that provides blood establishments with recommendations to reduce the risk of contaminating the US blood supply with the Zika virus, as well as preventing the spread of Zika through blood transmission in the US. The guidance touches on various areas, including donor screening, donor deferral, and product management, and applies to all blood establishments that collect whole blood and blood components. It does not, however, apply to the collection of Source Plasma, “which is used for further manufacture of plasmaderived products.”
Recommendations for Areas without Active Transmission of Zika
In areas where active Zika transmission is not present, FDA recommends that “at risk” donors be deferred from donating blood for four weeks. FDA defines “at risk” donors as individuals who have:
- Experienced symptoms suggestive of Zika within the past four weeks.
- Had sexual contact with an individual who has traveled to, or resided in, an area with active Zika virus transmission during the prior three months.
- Traveled to areas with active Zika transmission during the past four weeks.
Recommendations for Areas with Active Transmission of Zika
In areas where active transmission of the Zika virus is present, FDA recommends that blood establishments attempt to fulfil transfusion orders using Whole Blood and blood components obtained from areas of the U.S. without active transmission of Zika.
In addition, the Agency also provides recommendations for blood establishments located in areas with and without active Zika transmission, regarding:
- Donor education material
- Donor history questionnaire
- Donor deferral
- Post donation information
- Product management
FDA’s guidance includes a number of additional recommendations to prevent the spread of the Zika virus, as well as various strategies to implement these recommendations. Blood establishments located in areas with and without active Zika transmission should be knowledgeable on the information contained within the document.