EBAA continues to closely monitor the current Ebola disease outbreak in the Democratic Republic of the Congo and Uganda, as well as related federal guidance affecting donor eligibility and tissue safety. The Policy and Position Research Subcommittee (PPRS) of the Medical Advisory Board reviewed the recently released FDA blood establishment guidance and assessed its relevance to eye tissue donation and donor risk assessment.
FDA has since issued a safety communication for HCT/P establishments regarding Ebola disease and considerations for donor eligibility determinations. While the FDA did not issue guidance at this time for HCT/P establishments, EBAA Medical Standard D1.110 — EBAA Contraindications to Transplant excludes any donor with a history of Ebola Virus Disease (EVD). The following recommendations are intended to support consistent donor screening and risk assessment by EBAA member eye banks during the current outbreak.
Key Points about Ebola Disease
- Ebola disease is a severe viral illness caused by infection with an Ebola virus. Transmission occurs through direct contact with blood or other body fluids of a person who is sick with or has died from Ebola disease, or through contact with contaminated materials.
- The risk to the eye donor pool is considered low at present, but enhanced screening is recommended as a precaution due to the severity of Ebola disease and the potential for exposure through travel, residence, close contact, or sexual contact with a survivor.
- EBAA Medical Standards exclude any donor with a history of Ebola Virus Disease. This exclusion applies regardless of the time since recovery.
- Recent residence in or travel to a country with an active Ebola disease outbreak may represent a potential risk factor. FDA has indicated that it will notify blood establishments when additional Ebola-related screening measures should be implemented and will specify countries subject to travel and residency screening. For up-to-date information regarding the outbreak, please refer to the CDC website: https://www.cdc.gov/ebola/situation-summary/index.html.
- Close contact with a person confirmed to have Ebola disease or a person under investigation for Ebola disease may result in exposure to infectious body fluids and should be considered in donor risk assessment.
- Sexual contact with a person known to have recovered from Ebola disease is a recognized risk consideration. Ebola virus can persist in certain body fluids after clinical recovery, and FDA blood guidance recommends deferral based on sexual contact within the past 8 weeks with a known Ebola survivor, regardless of the time since that person’s recovery.
- There is limited evidence regarding transmission of Ebola virus through ocular tissue transplantation. The recommendations below are precautionary and intended to reduce potential risk to recipients and eye bank personnel.
Ebola Screening Recommendations for EBAA Member Eye Banks
Effective immediately, EBAA recommends that eye banks defer potential ocular tissue donors who meet one or more of the following criteria:
- Any history of Ebola Virus Disease, regardless of date of illness or recovery.
- Residence in or travel within the past 8 weeks before death/donation to a country with an active Ebola disease outbreak, as identified by FDA or other appropriate public health authorities.
- Close contact within the past 8 weeks before death/donation with a person confirmed to have Ebola disease or a person under investigation for Ebola disease whose diagnosis was pending.
For purposes of this recommendation, close contact includes contact that could have resulted in direct exposure to blood or other body fluids, including but not limited to:- providing healthcare or caregiving;
- living with the individual;
- handling the body or remains of an individual with suspected or confirmed Ebola disease;
- other direct exposure to potentially infectious body fluids.
- Sexual contact within the past 8 weeks before death/donation with a person known to have recovered from Ebola disease, regardless of the time since that person’s recovery.
- Notification by a public health authority within the past 8 weeks before death/donation that the donor may have been exposed to a person with Ebola disease.
Suggested Supplemental Donor Risk Assessment Questions
Until further notice, eye banks may consider adding the following supplemental questions to the DRAI or other donor screening process when Ebola screening is indicated:
- In the past 8 weeks, did she/he* have close contact or sexual contact with a person who was confirmed to have or suspected of having Ebola disease?
- In the past 8 weeks, was she/he* notified by a public health authority that she/he* may have been exposed to a person with Ebola disease?
These recommendations will remain in effect until further notice or until additional criteria are added, modified, or withdrawn based on updated information from FDA, CDC, WHO, or other public health authorities.
Eye banks should continue to follow all applicable FDA regulations, EBAA Medical Standards, state requirements, and internal medical director review processes.
