The European Directorate for the Quality of Medicines & HealthCare (EDQM) just published the 8th edition of the ‘Guide to the quality and safety of organs for transplantation’. This revised version collates state-of-the-art information to provide an important overview of the most recent developments in the ﬁeld and technical guidance to ensure the safety and quality of human organs intended for transplantation, with the ultimate goal of supporting professionals and improving the rate of successful and safe transplantation.
In this revised edition, all chapters have been thoroughly reviewed and new chapters have been added. This includes a new chapter on “Paediatric donation”, which explores all aspects of deceased donation in children and addresses the outcomes of organs obtained from paediatric donors. A novel chapter on “Communication of risk and shared decision-making” addresses consent for organ transplantation and living donation, and provides guidance for crisis management and communication when facing serious adverse reactions or events. Additionally, improvements have been introduced in the preparation of the chapters, such as the elaboration of evidence-based recommendations using the PICOS approach. Lastly, a “research agenda” has been included at the end of most chapters, identifying those topics where evidence is insufficient or non-existent and which should be given priority in research initiatives.
Both the European Society for Organ Transplantation (ESOT) and Centre of Evidence in Transplantation (CET) contributed to the development of this new edition by sharing their expertise to enrich the resulting guidance.