5.3. Notification of serious adverse reactions (Living donors)
1. Donor adverse reactions with a possible direct effect on the quality and safety of tissue/cells must be reported. These may be immediate, i.e. occurring at the time of the donation or within 8 days of donation, or they may be delayed, i.e. identified after the donation (possibly even many years later).
2. Where allogeneic living donors have been harmed by a donation process but there is no detrimental impact on the quality or safety of the specific tissues or cells concerned; a serious threat to the supply of those tissues or cells could result from the loss of public willingness to donate, or there may be implications for the safety of other living donors. On this basis, it is recommended that Competent Authorities include reporting of such donor adverse reactions in their tissue and cell vigilance programmes and in their annual reports to the EC. If such reactions are the result of an administered drug it will be reportable through the pharmacovigilance system. It should not be reported again through the tissue and cell vigilance system but appropriate communication links between responsible authorities should ensure that the tissue and cell Competent Authority is aware of these reactions.