Guide to the quality and safety of organs for transplantation
Transplant medicine and transplantation have progressed in recent decades in a way that nobody could have imagined before, yet demand for transplantable organs still far exceeds supply – with important consequences for health. The transplantation of organs oﬀers major therapeutic beneﬁts and improvements to quality of life and is, in many cases, the only life-saving treatment for end-stage organ failure. As with all substances of human origin, transplantation of human organs entails a risk of disease transmission. Comprehensive quality systems and appropriate donor screening and selection must therefore be in place to guarantee the best possible transplantation outcomes. The Guide to the quality and safety of organs for transplantation (Organ Guide) contributes to meeting this need.
The 8th Edition of the Organ Guide collates state-of-the-art information to provide an indispensable overview of the most recent advancements in the ﬁeld and technical guidance to ensure the safety and quality of human organs intended for transplantation, with the ultimate goal of improving successful and safe organ transplantation rates. Easy access to this information is essential for all stakeholders concerned – professionals involved in identifying possible organ donors, co-ordinators managing living or deceased donation pathways, those responsible for the allocation and clinical use of human organs, quality managers within the process, and health authorities responsible for donation and transplantation programmes.
Download the leaflet for more details on the 8th Edition of the Organ Guide.
The electronic version of the Guide can be downloaded for free online.
The paper version is available for purchase from the EDQM Store.
What has changed in the 8th Edition?
All chapters have been thoroughly revised according to the state of the art and new and important chapters have been added. A set of clinical questions was formulated for Chapters 5 and 11 – using the PICOS approach (population, intervention, comparator, outcomes, study design) – to formulate evidence-based recommendations where appropriate. A systematic review of the literature by the Centre for Evidence in Transplantation (CET) on specific questions enabled the working group to draft more robust recommendations on selected aspects of these two chapters.
A research agenda section has also been included at the end of most chapters, identifying fundamental topics for which evidence is insufficient or non-existent and where priority should be given in research initiatives.
Chapter 2, Identification and referral of possible deceased organ donors, describes best practice in this field and addresses challenging practices such as elective non-therapeutic ventilation and admission to intensive care units, to incorporate donation into end-of-life care.
Chapter 3, Determination of death by neurologic criteria, provides a detailed description of the physical examinations and ancillary tests necessary for the diagnosis of death by neurologic criteria, including situations such as anoxia, where the usual ancillary tests may pose challenges.
Chapter 4, Consent/authorisation for post mortem organ donation, describes the current European legal frameworks for consent and authorisation in organ donation, and best practice in supporting relatives of deceased organ donors and communicating bad news, including the timing of communication.
Chapter 5, Management of the potential donor after brain death, now includes an algorithm covering the whole process from identification of potential donors to organ donation, and the section on nutritional support has been expanded.
Chapter 6, General donor characterisation, assessment and selection criteria, now includes a donation process flowchart, with cross-references to relevant chapters of the guide, and a detailed description of imaging techniques.
Chapter 7, Specific organ characterisation, assessment and selection criteria, provides the information necessary to evaluate each organ individually.
Chapter 8, Risk of transmission of infectious diseases, has been fully revised to include up-to-date developments in the field of emerging pathogens, including COVID-19, with screening algorithms for an extensive list of pathogens. This chapter also takes into account the impact of new direct-acting antiviral agents in the treatment of hepatitis C virus infection and has updated recommendations on the use of organs from donors infected by this virus. It also addresses the use of organs from HIV-positive donors.
Chapter 9, Risk of transmission of cancer, has been entirely reviewed to cover risk assessment where donors may have a history of malignancies, addressing malignancies in the recipient caused by donor oncogenic viruses and a review of donors with genetic predispositions to cancer.
Chapter 10, Risks related to the use of organs from donors with other conditions and diseases, provides recommendations on the use of organs from donors either with conditions such as inherited or autoimmune diseases, or who are themselves organ transplant recipients.
Chapter 11, Organ procurement, preservation and transportation, has been entirely rewritten, providing up-to-date information on organ procurement and in situ and ex situ preservation techniques, including those that should apply to circulatory determination of death (DCD).
Chapter 12, Donation after circulatory death, presents best practice in realising the DCD pathway, both controlled and uncontrolled DCD (i.e. donation from persons who die following the decision to withdraw life-sustaining therapies that are no longer deemed beneficial to the patient, versus donation from persons who die following an unsuccessfully resuscitated cardiac arrest). For the first time a reference to DCD in the context of medically-assisted death or euthanasia, as a reality in some European countries, has been included.
Chapter 13, Living donation, now considers aspects of pancreas, small bowel and uterus living donation, in addition to the psychosocial aspects of living donation.
Chapter 14, Paediatric donation, covers all aspects of deceased donation in children, whether death is determined by neurologic or by circulatory criteria, and addresses the outcomes of organs involving paediatric donors.
Chapter 15, Donation of vascularised composite allografts, has been revised to present uterus transplantation in detail.
Chapter 16, Biovigilance and surveillance, has been extensively revised to provide clear guidance for healthcare professionals and healthcare authorities setting up biovigilance systems on how to identify, report, assess and manage severe adverse reactions and events (SAREs), in line with the Guide to the quality and safety of tissues and cells for human application.
Chapter 17, Achieving and measuring quality in organ donation and transplantation, provides detailed principles of quality management for organ donation, procurement and transplantation activities.
Chapter 18, Measuring outcomes in transplantation, reviews the factors to be considered when measuring outcomes in transplantation.
Chapter 19, Communication of risk, addresses consent for living donation and transplantation and provides guidance for crisis management and communication when facing SAREs.