Probabilistic Risk Assessment (PRA) and redesign of the evaluation process of the organ donors

The donation and transplantation process of organs, tissue and cells is very complex and time constrained, therefore risk management is crucial to guarantee an acceptable level of safety for patients and their families (Cook et al., 2007; Bellandi et al., 2010). The European Union set up a regulatory framework with 4 directives dedicated to quality and safety in transplants (86/2004, 24 and 43/2006; 75/2010), requiring a detailed risk assessment of the donor and of the organs, tissues and cells, the traceability of the entire process from the donor to the recipients, the notification and investigation into the eventual adverse events and reactions. Currently, the member states are devising national as well as continental programmes (i.e. EU projects Notify and EFRETOS) to fully implement the directives requirements.