Guide To Safety And Quality Assurance For The Transplantation Of Organs Tissues And Cells

Ce guide s'adresse à la transplantation d'organes et de tissus d'origine humaine pratiquée dans une finalité thérapeutique et donne des orientations à toutes les personnes concernées afin de garantir la meilleure qualité possible des organes, tissus et cellules, d'optimiser le taux de réussite des transplantations et de minimiser les risques. Il comprend des normes de sécurité et d'assurance de qualité pour la collecte, la conservation, le traitement de la distribution des organes, tissus et cellules d'origine humaine utilisées aux fins de transplantation.

Organ transplantation saves thousands of lives each day but raises some questions of principle. This guide, which is published on a biennial basis, provides guidance for all those involved in transplantation and other clinical applications of organs, tissues and cells, with the aim of optimising quality and reducing risks. The topics covered are: quality management, principles for ensuring the quality of organs, tissues and cells; selection of donors; organ procurement and preservation; tissue and cell procurement; tissue establishment; transplantation practices.

Organ transplantation is in many cases the only available treatment for end-organ failure. The transplantation of tissues and cells offers major therapeutic benefits and improvement of the quality of life, but raises a number of questions of principle. This is the 4th Edition of the Guide. This new edition provides sound information and guidance to all professionals involved in donation, transplantation and other clinical applications of organs, in order to optimise the quality and minimise the risks of these complex procedures. It has been elaborated to help professionals on a practical level, by providing easy-to-use information at the bed-side for transplant co-ordinators in Europe. In addition, it provides appropriate guidelines for quality and safety management of the multiple relevant procedures with respect to ethical principles. This Guide is compiled by leading European experts under the aegis of the European Committee (Partial Agreement) on Organ Transplantation (CD-P-TO). The Steering Committee was created in 2007 by the Council of Europe to pursue its activities in the field of organ transplantation following the transfer of these activities to the EDQM.

This 5th Edition of the Guide to the quality and safety of organs for transplantation collates updated information to provide professionals identifying organ donors, transplant co-ordinators managing the donation process and transplant physicians responsible for organ allocation and utilisation with a useful overview of the most recent advancements in the field. This guide is intended to provide easy-to-use information and guidance to all professionals involved in donation and transplantation of organs so as to maximise their quality and to minimise risks and, thereby, improve the success rate of transplants. The guide applies to the donation and transplantation of organs of human origin for therapeutic purposes. It covers important ethical principles that must always be respected in any donation and transplantation procedure, guidance on the assessment of donors to prevent the transmission of infectious, malignant or other diseases, recent views on donor management, as well as state-of-the-art information to ensure the quality and safety of organs during the multiple relevant procedures that take place from donation to transplantation. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. New information relating to quality and safety standards for tissues and cells for human application are now separately published in the Guide to the quality and safety of tissues and cells for human application

This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types