Commission Directive 2006/17/ECShow full title

ANNEX I SELECTION CRITERIA FOR DONORS OF TISSUES AND/OR CELLS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 3(a)

Selection criteria for donors are based on an analysis of the risks related to the application of the specific cells/tissues. Indicators of these risks must be identified by physical examination, review of the medical and behavioural history, biological testing, post-mortem examination (for deceased donors) and any other appropriate investigation. Unless justified on the basis of a documented risk assessment approved by the responsible person as defined in Article 17 of Directive 2004/23/EC, donors must be excluded from donation if any of the following criteria applies:

1. Deceased Donors

1.1. General criteria for exclusion

1.1.1. Cause of death unknown, unless autopsy provides information on the cause of death after procurement and none of the general criteria for exclusion set out in the present section applies.

1.1.2. History of a disease of unknown aetiology.

1.1.3. Presence, or previous history, of malignant disease, except for primary basal cell carcinoma, carcinoma in situ of the uterine cervix, and some primary tumours of the central nervous system that have to be evaluated according to scientific evidence. Donors with malignant diseases can be evaluated and considered for cornea donation, except for those with retinoblastoma, haematological neoplasm, and malignant tumours of the anterior segment of the eye.

1.1.4. Risk of transmission of diseases caused by prions. This risk applies, for example, to:

(a)

people diagnosed with Creutzfeldt–Jakob disease, or variant Creutzfeldt-Jacob disease, or having a family history of non-iatrogenic Creutzfeldt-Jakob disease;

(b)

people with a history of rapid progressive dementia or degenerative neurological disease, including those of unknown origin;

(c)

recipients of hormones derived from the human pituitary gland (such as growth hormones) and recipients of grafts of cornea, sclera and dura mater, and persons that have undergone undocumented neurosurgery (where dura mater may have been used).

For variant Creutzfeldt-Jakob disease, further precautionary measures may be recommended.

1.1.5. Systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated. Donors with bacterial septicaemia may be evaluated and considered for eye donation but only where the corneas are to be stored by organ culture to allow detection of any bacterial contamination of the tissue.

1.1.6. History, clinical evidence, or laboratory evidence of HIV, acute or chronic hepatitis B (except in the case of persons with a proven immune status), hepatitis C and HTLV I/II, transmission risk or evidence of risk factors for these infections.

1.1.7. History of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the tissue to be retrieved.

1.1.8. Indications that test results of donor blood samples will be invalid due to:

(a)

the occurrence of haemodilution, according to the specifications in Annex II, section 2, where a pre-transfusion sample is not available; or

(b)

treatment with immunosuppressive agents.

1.1.9. Evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration donor travel and exposure history and local infectious disease prevalence.

1.1.10. Presence on the donor’s body of physical signs implying a risk of transmissible disease(s) as described in Annex IV, point 1.2.3.

1.1.11. Ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.

1.1.12. Recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist.

1.1.13. Transplantation with xenografts.

1.2. Additional exclusion criteria for deceased child donors

1.2.1. Any children born from mothers with HIV infection or that meet any of the exclusion criteria described in section 1.1 must be excluded as donors until the risk of transmission of infection can be definitely ruled out.

(a)

Children aged less than 18 months born from mothers with HIV, hepatitis B, hepatitis C or HTLV infection, or at risk of such infection, and who have been breastfed by their mothers during the previous 12 months, cannot be considered as donors regardless of the results of the analytical tests.

(b)

Children of mothers with HIV, hepatitis B, hepatitis C or HTLV infection, or at risk of such infection, and who have not been breastfed by their mothers during the previous 12 months and for whom analytical tests, physical examinations, and reviews of medical records do not provide evidence of HIV, hepatitis B, hepatitis C or HTLV infection, can be accepted as donors.

2. Living donors

2.1. Autologous living donor

2.1.1. If the removed tissues and cells are to be stored or cultured, the same minimum set of biological testing requirements must apply as for an allogeneic living donor. Positive test results will not necessarily prevent the tissues or cells or any product derived from them being stored, processed and reimplanted, if appropriate isolated storage facilities are available to ensure no risk of cross-contamination with other grafts and/or no risk of contamination with adventitious agents and/or mix-ups.

2.2. Allogeneic living donor

2.2.1. Allogeneic living donors must be selected on the basis of their health and medical history, provided on a questionnaire and through an interview performed by a qualified and trained healthcare professional with the donor, in compliance with point 2.2.2. This assessment must include relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases or health risks to themselves. For any donation, the collection process must not interfere with or compromise the health or care of the donor. In the case of cord blood or amniotic membrane donation, this applies to both mother and baby.

2.2.2. Selection criteria for allogeneic living donors must be established and documented by the tissue establishment (and the transplanting clinician in the case of direct distribution to the recipient), based on the specific tissue or cells to be donated, together with the donor’s physical status and medical and behavioural history and the results of clinical investigations and laboratory tests establishing the donor’s state of health.

2.2.3. The same exclusion criteria must be applied as for deceased donors with the exception of point 1.1.1. Depending on the tissue or cell to be donated, other specific exclusion criteria may need to be added, such as:

(a)

pregnancy (except for donors of umbilical cord blood cells and amniotic membrane and sibling donors of haematopoietic progenitors);

(b)

breastfeeding;

(c)

in the case of haematopoietic progenitor cells, the potential for transmission of inherited conditions.