Tissue Donation – For EATB Website
Tissue donation is an altruistic act, which is made either by living donors, particularly of bone, amnion and occasionally heart valves, or by family members on behalf of their deceased family members. Without such altruistic acts the benefit of allogeneic tissue grafts for patients could not exist. It is the role of tissue facilities to balance their activities, bearing in mind the altruism of the donors to whom they have a duty of care, with the quality and safety of tissue grafts, whilst ensuring their sufficiency and availability for patients who will benefit from tissue transplantation. Clearly a strong ethical framework for this is required.
There are well documented, albeit rare, transplant transmitted infections in the literature. These cases have provided opportunities to learn and improve donor selection, testing, procurement and processing practices. Constant improvement has led to clear criteria for accepting donors, to avoid those who may be infected, avoiding contamination through methodologies and facilities meeting high standards, including mechanisms for decontamination and sterilisation of many tissues during processing and clear steps prior to the release of tissues for transplantation. Tissue banks have developed criteria for all aspects of their activities, often have expert advisers within their facilities or available in other institutions and have trained staff for all aspects of their work. Tissue facilities use audit and continuing professional development to maintain the expertise of their staff. There are criteria for medical and behavioural and travel history as well as for physical examination of the donor. Histology or other investigations may be undertaken as required and post-mortem reports and reports from primary care givers or from hospital notes and wards also yield important information. Testing for blood borne viruses by serology and in some circumstances by Nucleic Acid Technology (NAT) and using Standard Operating Procedures within established Quality Systems are all pat of the routine requirements for tissue banking.
In Europe, the European Commission Directives have provided a statutory regulatory framework for these activities, against which Competent Authorities in each Member State is required to licence or accredit tissue facilities. There are many examples of regional and national standard guidelines that expand upon the requirements of EC Directives. European projects, such as EUROCET undertakes to develop and maintain a register of donations of tissues, cells and organs and transplantation in new and old Member States. The development of Adverse Event and Reaction Reporting in recipients through the Eustite project and the involvement of clinicians using tissue grafts all make tissue donation and transplantation a constantly evolving service provision. Tissue bankers have been involved in the development of standards, including those of the EATB and there is cooperation between sister tissue banking associations. The World Union of Tissue and Cell Banking Associations, which had its second meeting in Kuala Lumpar in 2008, is formalising this cooperation. The European Commission has funded guidance for recommendations for tissue banking in the EQSTB Project, which worked to produce guidance in 4 areas through working groups looking at:
More details of the SANCO EQSTB project can be found at:http://sanco-eqstb.hospitalclinic.org/sanco/index-html