ACCEPT:

• If the material has a full product license from the Health Products Regulatory Authority (HPRA) or the European Medicines Agency (EMEA)

 PERMANENTLY EXCLUDE:

• If material from a living non-human animal source has been directly or indirectly in contact with the donor’s blood supply. This does not include animal bites
• Sexual partners, current and former, of people who have had material from a living non-human animal source directly or indirectly in contact with their blood supply (as described above)

ADDITIONAL INFORMATION

Xenotransplantation includes; Xenografts, Heterografts and Non-Human Organ Perfusion. Any procedure that involves the transplantation, implantation, or infusion into human recipient of either (a) live cells, tissues, or organs from a non-human animal source, or (b) human body fluids, cells, tissues, or organs that have had ex-vivo contact with live, non human animal cells, tissues, or organs.  Xenotransplantation products include live cells, tissues or organs used in xenotransplantation. Biological products, drugs, or medical devices sourced from non-living cells, tissues or organs from non-human animals, including but not limited to porcine insulin and porcine heart valves, are not considered xenotransplantation products. Exposure to non-human animal material, particularly when the person exposed is immunosuppressed, may result in infections that would not normally affect people.

Directive 2004/33/EC has a legislative requirement that prospective donors with a history of xenotransplants are permanently excluded.