TRANSFUSION MEDICINE: QUO VADIS? WHAT HAS BEEN ACHIEVED, WHAT IS TO BE EXPECTED

Transcription

1 TRANSFUSION MEDICINE: QUO VADIS? WHAT HAS BEEN ACHIEVED, WHAT IS TO BE EXPECTED

2 DEVELOPMENTS IN HEMATOLOGY AND IMMUNOLOGY Volume 36 The titles published in this series are listed at the end of this volume.

3 Transfusion Medicine: Quo Vadis? What Has Been Achieved, What Is to Be Expected Proceedings of the jubilee Twenty-Fifth International Symposium on Blood Transfusion, Groningen, 2000, Organized by the Sanquin Division Blood Bank Noord Nederland edited by C. TH. SMIT SIBINGA Blood Bank Noord Nederland, Groningen, The Netherlands and J. D. CASH Edinburgh, Scotland, U.K. SPRINGER-SCIENCE+BUSINESS MEDIA, B.V.

4 Library of Congress Cataloging-in-Publication Data ISBN DOI / ISBN (ebook) Printed on acid-free paper All Rights Reserved 2001 Springer Science+Business Media Dordrecht Originally published by Kluwer Academic Publishers in 2001 Softcover reprint of the hardcover 1st edition 2001 No part of the material protected by this copyright notice may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without written permission from the copyright owner.

5 COUNCIL OF EUROPE CONSEIL DE L'EUROPE This jubilee 25 th International Symposium was co-sponsored by WHO and conducted under the auspices of the Secretary General of the Council of Europe, Mr. Walter Schwimmer and the International Society of Blood Transfusion. Baxter Acknowledgement This publication has been made possible through the support of Baxter, which is gratefully acknowledged.

6 VII CONTENTS Moderators and Speakers... XI Foreword... XIII I. BLOOD SUPPLY SYSTEMS AND ORGANISATION Blood Transfusion: Quo Vadis? Customer Orientation as the Leading Principal for Blood Banks in the Future... 3 Th.E.P. Lotgerink Community Involvement: The Development, the Past - the Present and the Future of Blood Donations as a Form of Community Involvement A.P.M. Los Structure and Commitments - Blood Supply Systems and Organization lc. Emmanuel Applying Decision Analysis to Transfusion Medicine in the Real World to Improve Transfusion Safety lp. AuBuchon Cost-Effectiveness of HIV NAT Screening for Dutch Donors M.J. Postma Legal and Regulatory Aspects of Blood Transfusion M.L. Kavanagh Discussion II. TECHNICAL AND PHARMACEUTICAL DEVELOPMENTS Freezing and Vitrification of Red Cells, Recollections and Predictions H.T. Meryman Plasma Fractionation P.R. Foster Viral Marker Screening: Is More Testing Safer? J-P. Allain

7 VIII Inactivation of Viruses, Bacteria, Protozoa, and Leukocytes in Labile Blood Components by Using Nucleic Acid Targeted Methods L.M. Corash Alternatives to Human Blood Resources P.M. Ness Discussion III. QUALITY PRINCIPLES AND RISK MANAGEMENT Quality Systems and Management: 2000 Where Have We Been and Where Are We Going? K. Sazama Traceability and Coding Principles J. Koistinen Quality Principles and Risk Management: Automation and Documentation.., 173 M. Bruce Haemovigilance N. Drouet Human Resources: Teaching and Training in Transfusion Medicine F. Harrison Discussion IV. TRANSFUSION MEDICINE AT THE BEDSIDE The Epidemiology of Blood Component Transfusion in South Eastern Scotland, 1990 to D.B.L. McClelland Contributions of Meta-Analysis to Transfusion Medicine E.e. Vamvakas Immunomodulation: Facts and Interpretations A. Brand Development and Implementation of New Cellular Therapies J. McCullough Transfusion Medicine and the Development of Gene Therapy M.L. Turner Making Policy in the 2000s J.e. Emmanuel Discussion Index

8 IX MODERATORS AND SPEAKERS Moderators J.D. Cash (chairman) W.G. van Aken D.H. Buchholz F. Canal S. Poppema C.Th. Smit Sibinga H.J.C. de Wit Speakers J-P. Allain J.P. AuBuchon A. Brand K-F Bopp M. Bruce L. Corash N.Drouet J.C. Emmanuel - Edinburgh, Scotland, UK - Sanquin Blood Supply Foundation, Division CLB, Amsterdam, NL - Baxter Healthcare Corporation, Round Lake, IL, USA - Fenwal Europe, Madrid, E - University ofgroningen, Faculty of Medical Sciences, Groningen, NL - Sanquin Blood Supply Foundation, Division Blood Bank Noord Nederland, Groningen, NL - Sanquin Blood Supply Foundation, Amsterdam, NL - East Anglian Blood Centre, Cambridge, UK - Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA - Sanquin Blood Supply Foundation, Division Blood Bank Leiden-Haaglanden, Leiden, NL - Directorate III - Social Cohesion, Health and Social Policy Division, Council of Europe, Strasbourg, F - SNBTS Headquarters, Edinburgh, Scotland, UK - Cerus Corporation, Concord, CA, USA - University Centre of Grenoble, Grenoble, F - Department of Blood Safety and Clinical Technology, WHO, Geneva, CH

9 x P.R. Foster J.F. Harrison M. Kavanagh J. Koistinen A.P.M. Los Th.E.P. Lotgerink D.B.L. McClelland J. McCullough H.T. Meryman P.M. Ness K. Sazama M.L. Turner E.C. Vamvakas - Protein Fractionation Centre, Edinburgh, Scotland, UK - National Blood Service, London, UK - Medicines Control Agency, London, UK - Finnish Red Cross BTS, Helsinki, SF - Sanquin Blood Supply Foundation, Division Blood Bank Noord Nederland, Groningen, NL - Science & Business Connection, Groningen, NL - Scottish National Blood Transfusion Service, Edinburgh, Scotland, UK - Center for Molecular and Cellular Therapy, Minneapolis, MN, USA - Naval Medical Research Institute, Bethesda, MD, USA - John Hopkins Hospital, Baltimore, MD, USA - U.T. M.D. Anderson Cancer Center, Houston, TX,USA Edinburgh & S.E. Scotland BTS, Edinburgh, Scotland, UK - Blood Bank, New York University Medical Center, New York, NY, USA Prepared Discussant M.J. Postma - Groningen University Institute for Drug Exploration, Groningen, NL

10 XI FOREWORD It is a great pleasure for me to open the jubilee 25 th International Symposium on Blood Transfusion here in Groningen. This symposium is co-sponsored by the World Health Organization and is being held under the auspices of the ISBT and the Secretary General of the Council of Europe, Mr Walter Schwimmer. The patronage was granted with great pleasure for several reasons. First of all, Dutch experts are very active in our Committees and have largely contributed in developing the Council of Europe principles in the blood area. Secondly, the Council of Europe is active today in the area of blood transfusion due to a tragic event, which occurred in 1953 in the Netherlands; following a flooding many of the blood products given for assistance' could not be used due to incompatibilities and differences in labelling. Some words to present the Council of Europe since the organisation is sometimes confused with institutions ofthe European Union: The organisation has been founded in 1949 to establish the principles of democracy and rule of law all over Europe. Since 1989, the year of the fall of the Berlin wall and the opening up of the iron curtain, these principles could be extended to the countries of Central and Eastern Europe. Today this makes the Council of Europe the only pan-european organisation with 41 Member States thus representing more than 750 million people. Why, as an organisation promoting and protecting human rights, do we deal with issues related to blood transfusion? The reason is that the human body and its parts should not, as such, give rise to financial gain or comparable advantage. Ladies and Gentlemen, in the first part of this symposium you are reviewing achievements made in the blood transfusion over the last 25 years. I would like to use this occasion to recall the role and the contribution of the Council of Europe in this field over the last 50 years. Activities before 1989 In the beginning of the 50ties, the work of the Council of Europe in the blood transfusion area has been built around three major principles; voluntary and nonremunerated donation, the goal to achieve self-sufficiency and the protection of both the donors and the recipients.

11 XII With these objectives in mind, the Council of Europe concentrated on studying the ethical, legal and organisational aspects of blood transfusion with a view to ensuring quality, increasing availability of blood, ensuring optimal use and analysing the possible ethical and organisational impact of new scientific developments. The first Agreement on the exchange of substances of human origin was adopted in It was followed by Agreements on the exchange of blood grouping reagents and tissue-typing reagents in 1962 and 1976 respectively. All three European Agreements (No 26, 39 and 84) ensured at that time free movement throughout Europe of blood and blood products, as well as of blood grouping and tissue-typing reagents in cases of emergency. In 1968 a European bank of frozen blood of rare groups was set up in Amsterdam, the Netherlands to provide for the storage of extremely rare blood where the quantities collected at national level were insufficient. Activities After 1989 With the opening up of the iron curtain, the new challenge was to extend the Council of Europe principles to the new Member States from Central and Eastern Europe. In 1993, a survey on «Blood transfusion services of central and eastern European countries and their co-operation with Western transfusion services)} was published [1]. The special concern of the Council of Europe in sponsoring this study was to ensure within «Greater Europe)} : Harmonisation of policies Promotion of voluntary, non-remunerated donation Stability and self-sufficiency of blood transfusion services Introduction of quality standards for both blood and plasma products A Pan-European Conference followed in 1994 on the Restructuring of Blood Transfusion and Plasma Fractionation in Central and Eastern Europe. As an immediate result, a Task Force on Blood Transfusion has been created with the aim of helping in restructuring the countries' blood transfusion services. Since then, Task Force missions have taken place in Estonia, Lithuania, Latvia, Slovak Republic, Bulgaria and Romania. Recently, budgetary provisions have been made available to carry out a Task Force mission to Albania in Task Force missions have always been prepared by a Group, which included Dr. Emmanuel from WHO. The excellent co-operation with WHO in this field is highly appreciated. A specific programme called ADACS (Activities for the Development and Consolidation of Democratic Stability) had been set up, which included in 1998 a training course on blood transfusion organised in Sofia with participants from Bulgaria, Romania and FYROM (Former Yugoslav Republic of Macedonia). In 1999, a workshop in Corfu, hosted by the Greek Authorities on "Quality management and organisation of blood transfusion services" bringing together transfusion specialists from Albania, FYROM, Russia and Ukraine. Dr. Smit Sibinga was one of the main speakers at this workshop.

12 XIII A major success story started in 1995, when the Council of Europe adopted a Guide to the preparation, use and quality assurance of blood components as technical appendix to Recommendation No R (95) 15, on which many countries base formal national blood transfusion guidelines. It has been translated into numerous languages including Spanish, Russian and Japanese. Updated annually, the 6 th edition was published in January 2000 and preparations for the 7th edition are in a very advanced stage. The "Guide", as it is called, is of great interest to blood transfusion centres, legislators, health personnel and all those working in the field of blood transfusion. Reference to its chapter on selection of donors is made in the European Pharmacopoeia monograph on Human Plasma for Fractionation as well as in the relevant notes for guidance on plasma-derived products issued by the European Medicines Evaluation Agency (EMEA). I am pleased to announce that the complete 6 th edition has just now been put on our web site, which should foster its use to an even wider audience. Current activities of the Council of Europe in the area of blood transfusion include the elaboration of Recommendations on the prevention of the possible transmission of variant Creutzfeldt-lakob disease (vc1d) by blood transfusion and on the hospital's and clinician's role in the optimal use of blood. A study on pathogen inactivation of labile blood components is nearly finalised. Outlook I am glad to learn from the programme, that you are also looking into what is to be expected in the future. New techniques may become daily practice soon; inactivation/elimination of bio-burden; alternatives to human blood resources; the development of gene therapy. We thus approach a zero risk for the greater safety of the public. However, the question of cost/benefit ratio has then to be addressed. Health Authorities are depending on your advice. Thank you again for the invitation. I wish you a good symposium with fruitful discussions. Gabriella Battaini-Dragoni, Director of Social Affairs and Health Council of Europe