Human Tissue Authority

The regulator for human tissue and organs

Ebola virus – donor deferral guidance for organ donation and transplant sector

Update: 16 October 2014

In our communication of 8 October we advised that other agencies and organisations were developing specific guidance on the Risks of Transmission of Ebola virus related to donated blood and other substances of human origin (SoHO).

The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) has now published authoritative guidance (PDF). The HTA recommends strongly that individuals working in the Organ Donation and Transplant sector refer to this guidance and put in place systems for implementing the recommended donor deferrals, and ensure the cessation of imports of SoHO from Ebola affected areas.

HTA communication 8 October 2014

The European Centre for Disease Prevention and Control (ECDC) has produced a technical document (PDF) which sets out donor deferral guidelines to mitigate the risk of transmission of the Ebola virus via blood and blood components, cells, tissues and organs (substances of human origin – SoHO).

We recommend strongly that individuals working in the human application sector put in place systems for implementing the recommended donor deferrals, and ensure the cessation of imports of SoHO from Ebola affected areas.

Background to the Recommendations

The epidemic of Ebola virus disease (EVD) in West Africa in 2014 has increased the risk of Ebola virus transmission via blood and blood components, cells, tissues and organs (substances of human origin – SoHO) donated by residents of affected areas, travellers returning from affected areas or other potential donors who have been exposed to the disease. There are currently no specific EU regulations or recommendations for the safety of SoHO donated in such circumstances, or imported from affected areas.

Ebola virus infections transmitted via transfusions have not been described, nor has Ebola virus transmission through donated tissues or organs been documented. In addition, travellers from countries affected by EVD are deferred for donation because there is an overlap of Malaria risk countries in Africa with those at risk of EVD.

However, as there is a risk that the current outbreaks may spread to areas not affected by Malaria risk, the European Centre for Disease Prevention and Control (ECDC) has issued the attached Public Health Emergency Technical Document providing recommendations for the safety of SoHo donations.

The updated list of affected areas may be found on the ECDC website.

The HTA is aware that other agencies or organisations are developing their own specific guidance. When this is available we shall ensure that establishments are advised of it and provide links via our website.

The HTA has been advised that SaBTO is developing authoritative guidance and this shall be issued shortly.

NHSBT have issued more specific guidance for the ODT sector. This document, entitled “Implications of Ebola outbreak in West Africa for Organ Donation in the UK”, was attached  to an AMD communication in August and may be found on the NHSBT ODT clinical website www.odt.nhs.uk.

If you have any queries please contact us. Our email address is licensing.enquiries@hta.gov.uk.

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