Council for europe portal
Language : en Search
Choose language

Guide to the quality and safety of organs for transplantation

What has changed in the 6th Edition?

In the sixth edition, all chapters carried over from the fifth edition have been thoroughly updated and extensively revised. In addition, some new and important chapters have been added.

  • The new chapter on ‘Determination of death by neurologic criteria’ addresses the fundamental principles of brain death diagnosis and expands on the key decisions that follow. 
  • The new chapter ‘Consent/authorisation for post mortem organ donation’ focuses on the different legal systems for consent or authorisation to enable the donation of organs and tissues after death and provides guidance on how to approach and communicate with families.
  • The former chapter on assessment of donors has been divided into two new, more comprehensive chapters.  The first on ‘Deceased donor and organ characterisation’ describes how to assess the suitability of donors and organs, on undertake an adequate risk-benefit analysis and to optimise organ allocation. The second on ‘Donor and organ assessment and selection criteria’ clarifies the difference between expanded criteria and non-standard risk donors: a quality versus a safety concept.  From the safety perspective, this chapter provides a classification of donors in terms of risk of disease transmission.
  • The chapter on ‘Risk of transmission of infectious diseases’ has been revised to include up-to-date developments in the field of emerging pathogens. Additionally, screening algorithms have been extensively updated and a new section on infections of the central nervous system has been included.
  • The chapter on ‘Risk of transmission of neoplastic diseases’ has been fully updated and revised providing guidance for the assessment and grading of the risk of transmission for an extensive list of malignancies present in the donor history or incidentally identified at the time of organ recovery.
  • The new chapter on ‘Living Donation’ provides an overview of an activity that is progressively expanding in Europe, addressing a number of legal, ethical, medical, technical and organisational aspects of this practice.
  • The new chapter on ‘Donation after circulatory death’ focuses on donation from persons declared dead using circulatory criteria. It gives concrete recommendations for the development and optimisation of programmes for both controlled and uncontrolled donation after circulatory death, providing useful guidance to authorities and professionals initiating or consolidating this practice.
  • The chapter on ‘Biovigilance’ has been expanded, particularly describing how to identify, report, assess and manage severe adverse reactions and events. In strict alignment with the EU directives, the chapter clarifies concepts and provides guidance on the implementation of good vigilance and surveillance practices.
  • Finally, the chapter on ‘Quality management in organ donation and transplantation’ has been completely rewritten to provide detailed principles of quality management systems in organ donation and for transplantation activities, including separate reviews of government and health authority responsibilities.


twitter facebook googleplus pinterest linkedin email