Guide to Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells


Book Description

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.




Guide to Safety and Quality Assurance for Organs, Tissues, and Cells


Book Description

This is the second edition of this publication which contains guidance on the transplantation of organs, tissues and cells of human origin for therapeutic purposes. It sets out safety and quality assurance standards for the procurement, preservation, processing and distribution of human organs, tissues and cells, in order to promote ethical concerns which recognise the safety and dignity of the donor and the recipient. The guide also contains the additional protocol to the Convention on Human Rights and Biomedicine on the transplantation of organs and human tissues.







Guide to the Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells


Book Description

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.




Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy


Book Description

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.




Guide to the Quality and Safety of Tissues and Cells for Human Application


Book Description

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




Altruism Reconsidered


Book Description

As the use of human body parts has become increasingly commercialized, a need has arisen for new approaches to regulation that moves beyond the paradigm of altruism. During the course of this discussion, the notion of property has become a key concept. Focusing on practical and conceptual perspectives, the multidisciplinary group of authors, which includes specialists in philosophy, law, sociology, biology and medicine, have come together with practicing lawyers to consider both legal provisions and patterns of regulation in countries across Europe. Identifying divergences between different legal traditions, the authors explore various conceptual models which could be used to improve and to guide policy making. With this twin focus on practical and conceptual perspectives, this volume sets the standard for a detailed and innovative discussion of issues surrounding the regulation of research on human tissue.




Transplants


Book Description

This publication raises many ethical concerns about the current state of transplants and xenotransplantations in Europe today, including organ shortages, waiting lists and organ trafficking. It also presents the situation (and legislation) in many European countries, the Council of Europe's work in this field and the standpoints held by different religions vis-á-vis transplants. It also includes information on relevant legislation, international transplant statistics, useful websites and a glossary.







Surgery of the Meniscus


Book Description

​This book, published in cooperation with ESSKA, provides an exhaustive review of the meniscus and its pathology, covering all aspects from the basic science of the normal meniscus to clinical and imaging diagnosis, meniscus repair and meniscectomy, outcomes and complications, postoperative management, and emerging technologies. The book opens by examining in depth aspects such as anatomy, histology, physiology, biomechanics, and physiopathology. Clear guidance is offered on arthroscopy and the classification of meniscal lesions, with consideration of the full range of meniscal pathology, including traumatic lesions, degenerative lesions, root tears, meniscal cysts, and congenital lesions. Choice of treatment in different settings is explained, and the various surgical techniques – meniscectomy, meniscal repair, and reconstruction with allografts – are described in detail with the aid of accompanying videos and with presentation of long-term results. The concluding chapter takes a look into the future of meniscus reconstruction, for example through regeneration using mesenchymal stem cells.