Evaluating Donors for Risk of Ebola Virus Infection

Information on this page is based on the January 2017 FDA Guidance:
"Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry” (the Ebola Risk Guidance).
 
Refer to AABB’s Ebola Toolkit (members only) updated in May 2020 for instructions on implementation of FDA recommendations.
To revise your DHQ refer to this example: AABB Ebola DHQ and flowcharts.

1) What is required when there is no widespread transmission?

FDA’s current recommendations state:
In the absence of widespread transmission, “...self-deferral of donors with a history of Ebola virus infection or disease should provide sufficient protection.”
You should:

• Continue to use the updated educational material (required in April 2017) to support self-deferral by those who have a history of Ebola virus infection or disease (EVD).
• Refer to this example to ensure SOPs provide for implementation of the donor history questionnaires (full length, and abbreviated, if used) modified for EVD risk, if needed: AABB Ebola DHQ and Flowcharts.
• Become familiar with:
• the Ebola Toolkit (includes the checklist and flowchart) updated in May 2020.
• the information on the CDC website. The history of events on that page will be updated at the time of widespread transmission.
• Other resources on the CDC website: CDC: Ebola page; CDC: Signs and Symptoms.

2) How will I know to implement the additional regulations based on widespread transmission?

• AABB will communicate that the widespread transmission has triggered the Ebola recommendations to AABB members and accredited facilities.
• FDA and/or CDC will announce that CDC has classified one or more countries with “widespread transmission of Ebola virus disease (EVD) or with cases in urban areas with uncertain control measures.”
• Refer to FDA’s confirmation of the process during widespread transmission offered at the 2018 Ask the FDA and CMS/CLIA Transcript.

3) What should I do when CDC classifies one or more countries with “widespread transmission of Ebola virus disease (EVD) or with cases in urban areas with uncertain control measures?”

Within 4 weeks of the date of widespread transmission, you should implement:

• Updated donor education materials to assist donors with the 5 additional questions.
  Refer to Ebola Education Material.
• Updated DHQs to assess and defer donors based on Ebola risk.
  Refer to AABB Ebola DHQ and Flowcharts.

4) How long are these Ebola recommendations in place?

• AABB will communicate that CDC has determined that there is no longer widespread transmission. This communication will be triggered when CDC change to classification to “a country with former widespread transmission of Ebola virus.”
• You can discontinue the Ebola Risk recommendations 4 weeks AFTER the CDC determines no countries have widespread transmission.
• You should return to use of donor education material for self-deferral for a history of EVD.

5) How do we handle post donation information (PDI) and other inventory management concerns?

• Section III.C., pages 6-7 of the guidance, addresses “Product Retrieval, Quarantine, and Notification.”
• The Ebola virus guidance includes a unique approach to PDI.
• Refer to recommendation III.C.2, page 7, which states: “We recommend you contact FDA as soon as possible upon learning that you collected blood or blood components from a donor later determined to have Ebola virus infection or disease.”

Please contact regulatory@aabb.org with questions or for additional information.