13/14 December 2022
The FDA has determined Ebola virus as a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). With this issued guidance document the authority therefore wants to provide recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country.
Currently the collected scientific data and empiric experiences shows, that there can be a low level viremia in patiens after recovery from illness. And a pre-symptomatic viremia of infected people is not extensively investigated, but the risk can not be excluded. For sure is, that blood and blood products from symptomatic individuals would have the potential of transmitting Ebola virus to recipients if they were to donate. Healthcare providers caring for symptomatic Ebola patients, and family and friends in close contact with symptomatic Ebola patients, are at the highest risk of becoming infected because they may come in direct contact with infected blood or other body fluids of sick patients. Therefore, the FDA decided that Ebola virus meets the definition of TTI in 21 CFR 630.3(l).5.
With regard to the applicability of that guideline the FDA stated in this document :
"This guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations in section III. of this guidance document apply to the routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The collection of convalescent plasma from EVD survivors is addressed in section V. of this guidance document. This guidance finalizes the draft guidance entitled, “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus,” dated December 2015."
More detailed information about the recommendations can be found directly in the "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".