AATB Working to Develop Resources Following FDA Ebola Safety Communication

AATB is aware of the FDA Safety Communication issued on July 10, 2026, titled Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Ebola Disease and HCT/P Donation. 

Since the announcement, AATB has been working through its Emerging Infectious Diseases (EID) Working Group, a joint effort of the Physicians Council and the Scientific and Technical Affairs Council, and the Donor Risk Assessment Interview (DRAI) Subgroup of the Standards Committee, in collaboration with partner organizations, to review the FDA’s recommendations and develop practical implementation resources for tissue establishments. 

Current efforts include:  

• Developing Ebola-specific addendum questions for the DRAI forms to support donor eligibility determinations. 
• Creating a decision-making flow chart to support consistent application of the FDA’s recommendations. 

The FDA has indicated that the risk of Ebola transmission through HCT/Ps remains theoretical and that the overall risk to the United States is currently low. The agency recommends that establishments consider specific Ebola-related risk factors during donor eligibility determinations, particularly for potential exposures occurring within the 21 days prior to recovery. 

Our working groups are moving quickly to develop these resources, and we expect to share additional information with members in the coming weeks. Thank you for your continued commitment to donor safety and to maintaining the highest standards in the recovery, processing, and transplantation of HCT/Ps. 

For questions, or additional information, please contact the AATB Standards Department at standards@aatb.org.