Developments in Ophthalmology

Transcription

1 Eye Banking

2 Developments in Ophthalmology Vol. 43 Series Editor W. Behrens-Baumann Magdeburg

3 Section Title Eye Banking Volume Editors Timm Bredehorn-Mayr Halle (Saale) Gernot I.W. Duncker Halle (Saale) W. John Armitage Bristol 41 figures, 11 in color, and 12 tables, 2009 Basel Freiburg Paris London New York Bangalore Bangkok Shanghai Singapore Tokyo Sydney

4 T. Bredehorn-Mayr Martin-Luther-Universität Halle-Wittenberg Klinikum der Medizinischen Fakultät Universitätsklinik und Poliklinik für Augenheilkunde Ernst-Grube-Str. 40 DE Halle (Saale) (Germany) G.I.W. Duncker Martin-Luther-Universität Halle-Wittenberg Klinikum der Medizinischen Fakultät Universitätsklinik und Poliklinik für Augenheilkunde Ernst-Grube-Str. 40 DE Halle (Saale) (Germany) W.J. Armitage University of Bristol Bristol Eye Hospital Lower Maudlin Street Bristol BS1 2LX (UK) Library of Congress Cataloging-in-Publication Data Eye banking / volume editors, Timm Bredehorn-Mayr, Gernot I.W. Duncker, W. John Armitage. p. ; cm. -- (Developments in ophthalmology, ISSN ; v. 43) Includes bibliographical references and indexes. ISBN (hard cover : alk. paper) 1. Eye banks. 2. Cornea--Transplantation. I. Bredehorn-Mayr, Timm. II. Duncker, Gernot. III. Armitage, W. John. [DNLM: 1. Corneal Transplantation--Europe. 2. Eye Banks--organization & administration--europe. W1 DE998NG v / WW 170 E ] RE89.E dc Bibliographic Indices. This publication is listed in bibliographic services, including Current Contents. Disclaimer. The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publisher and the editor(s). The appearance of advertisements in the book is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements. Drug Dosage. The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any change in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Copyright 2009 by S. Karger AG, P.O. Box, CH 4009 Basel (Switzerland) Printed in Switzerland on acid-free and non-aging paper (ISO 9706) by Reinhardt Druck, Basel ISSN ISBN e-isbn

5 Section Title Contents VII List of Contributors XI Preface Bredehorn-Mayr, T.; Duncker, G.I.W. (Halle (Saale)); Armitage, W.J. (Bristol) 1 Corneal Grafting and Banking Ehlers, N.; Hjortdal, J.; Nielsen, K. (Århus) 15 European Eye Bank Association Jones, G.L.A.; Ponzin, D. (Venice); Pels, E.; Maas, H. (Amsterdam); Tullo, A.B. (Manchester); Claerhout, I. (Ghent) 22 Donor Selection, Retrieval and Preparation of Donor Tissue Donor Selection Borderie, V.M. (Paris) 31 Organ Culture Preservation for Corneal Tissue Technical and Quality Aspects Pels, E.; Rijneveld, W.J. (Amsterdam) 47 Endothelial Evaluation in the Cornea Bank Schroeter, J.; Rieck, P. (Berlin) 63 Cryopreservation for Corneal Storage Armitage, W.J. (Bristol) 70 Quality Management in European Eye Banks Toniolo, M.; Camposampiero, D.; Griffoni, C.; Jones, G.L.A. (Venice) 87 Allocation of Corneas in Europe Bokhorst, A.G.; Dorrepaal, C.A. (Leiden) 97 Preparation and Preservation of Amniotic Membrane Dekaris, I.; Gabrić, N. (Zagreb) 105 Preparation and Use of Human Sclera Grafts in Ophthalmic Surgery Töteberg-Harms, M. (Zurich/Halle (Saale)); Bredehorn-Mayr, T. (Halle (Saale)) 109 Culturing of Retinal Pigment Epithelium Cells Valtink, M. (Dresden); Engelmann, K. (Dresden/Chemnitz) V

6 120 Costs and Financing A Cost Calculation of an Up-to-Date Eye Bank in Germany Böhringer, D.; Maier, P.; Sundmacher, R.; Reinhard, T. (Freiburg) 125 Practical Implications of the Law on Tissues for Cornea Banks in Germany Hauswald, C. ; Bredehorn-Mayr, T. (Halle (Saale)) 131 European Association of Tissue Banks Cahane, M. (Tel Hashomer); van Baare, J. (Best) 136 Author Index 137 Subject Index VI Contents

7 Section Title List of Contributors W. John Armitage, Prof., BSc, PhD Department of Clinical Science University of Bristol Lower Maudlin Street Bristol BS1 2LX (UK) Daniel Böhringer, PD Dr. med. Universitätsaugenklinik Freiburg Killianstrasse 5 DE Freiburg (Germany) A.G. Bokhorst, MD, MPH BIS Foundation PO Box 2304 NL 2301 CH Leiden (The Netherlands) Vincent M. Borderie, MD, PhD Centre Hospitalier National d Ophtalmologie des XV XX 28, rue de Charenton FR Paris (France) Timm Bredehorn-Mayr, Dr. med. Martin-Luther-Universität Halle-Wittenberg Klinikum der Medizinischen Fakultät Universitätsklinik und Poliklinik für Augenheilkunde Ernst-Grube-Str. 40 DE Halle (Saale) (Germany) Michael Cahane, MD EATB Ocular Council and Sheba Medical Center Eye Bank Tel Hashomer (Israel) Davide Camposampiero, BSc Fondazione Banca degli Occhi del Veneto ONLUS Via Paccagnella n. 11 Padiglione Rama IT Zelarino Venice (Italy) Ilse Claerhout, MD, PhD Ghent University Hospital De Pintelaan 185 BE 9000 Ghent (Belgium) Iva Dekaris, Prof., MD, PhD Eye Clinic Svjetlost Heinzelova 39 HR Zagreb (Croatia) Caroline A. Dorrepaal, MD, PhD BIS Foundation PO Box 2304 NL 2301 CH Leiden (The Netherlands) G.I.W. Duncker, Prof. Martin-Luther-Universität Halle-Wittenberg Klinikum der Medizinischen Fakultät Universitätsklinik und Poliklinik für Augenheilkunde Ernst-Grube-Str. 40 DE Halle (Saale) (Germany) Niels Ehlers, Dr. Århus University Hospital Nørrebrogade 44 DK 8000 Århus C (Denmark) VII

8 Katrin Engelmann, Prof. Dr. med. Städtisches Klinikum Chemnitz ggmbh Flemmingstraße 2 DE Chemnitz (Germany) Nikica Gabrić, Prof., MD, PhD Eye Clinic Svjetlost Heinzelova 39 HR Zagreb (Croatia) Carlo Griffoni, BSc Fondazione Banca degli Occhi del Veneto ONLUS Via Paccagnella n. 11 Padiglione Rama IT Zelarino Venice (Italy) Claudia Hauswald Interdisciplinary Center for Medicine Ethics and Law Martin-Luther-University Halle-Wittenberg DE Halle (Saale) (Germany) Jesper Hjortdal, Dr. Århus University Hospital Nørrebrogade 44 DK 8000 Århus C (Denmark) Gary L. A. Jones, BSc (Econ) Fondazione Banca degli Occhi Administrator, European Eye Bank Association Fondazione Banca degli Occhi del Veneto ONLUS Via Paccagnella n. 11 Padiglione Rama IT Zelarino Venice (Italy) Hanneke Maas-Reijs Cornea Bank Amsterdam, Euro Tissue Bank p/a NIN Meibergdreef 47 NL 1105 BA Amsterdam (The Netherlands) P. Maier, Dr. med. Universitätsaugenklinik Freiburg Killianstrasse 5 DE Freiburg (Germany) Kim Nielsen, Cand. Scient., PhD Århus University Hospital Nørrebrogade 44 DK 8000 Århus C (Denmark) E. Pels, PhD Cornea Bank Amsterdam Euro Tissue Bank p/a NIN Meibergdreef 47 NL 1105 BA Amsterdam (The Netherlands) Diego Ponzin, MD Fondazione Banca degli Occhi del Veneto ONLUS Via Paccagnella n. 11 Padiglione Rama IT Zelarino Venice (Italy) T. Reinhard, Prof. Dr. med. Universitätsaugenklinik Freiburg Killianstrasse 5 DE Freiburg (Germany) Peter Rieck, Prof. Dr. Cornea Bank Berlin Charité Universitätsmedizin Berlin Campus-Virchow-Klinikum Augustenburger Platz 1 DE Berlin (Germany) W.J. Rijneveld, MD Cornea Bank Amsterdam Euro Tissue Bank p/a NIN Meibergdreef 47 NL 1105 BA Amsterdam (The Netherlands) Jan Schroeter, Dr. Cornea Bank Berlin Charité Universitätsmedizin Berlin Campus-Virchow-Klinikum Augustenburger Platz 1 DE Berlin (Germany) R. Sundmacher, Prof. Dr. med. Universitätsaugenklinik Freiburg Killianstrasse 5 DE Freiburg (Germany) VIII List of Contributors

9 Mauro Toniolo, Dipl.Tech. Fondazione Banca degli Occhi del Veneto ONLUS Via Paccagnella n. 11 Padiglione Rama IT Zelarino Venice (Italy) M. Töteberg-Harms Eye Clinic University Hospital of Zurich CH 8032 Zurich (Switzerland) Andrew B. Tullo, MD, FRCOphth Manchester Eye Bank Manchester Royal Eye Hospital Oxford Road M13 9WH Manchester Monika Valtink, Dipl.-Ing. (FH) Institute of Anatomy Medical Faculty Carl Gustav Carus TU Dresden Fetscherstr. 74 DE Dresden (Germany) Jeroen van Baare, Dr., MSc Dutch Health Care Inspectorate Program 8 Product Safety Wilhelmina van Pruisenweg 52 NL 2595 AN Den Haag (The Netherlands) List of Contributors IX

10 Section Title Preface Corneal transplantation has been performed with increasing success for more than 100 years. In the last 20 years, standards, outcomes and developments in the field of corneal transplantation and eye banking have been discussed at the annual meetings of the European Eye Bank Association (EEBA) to share and promote good practice and guarantee a high level of safety for the recipients. The EEBA standards for donor selection and eye banking provide professional advice and guidance to eye banks and corneal surgeons. The EU Tissues and Cells Directive (2004/23/EC) and its accompanying technical directives (Commission Directives 2006/17/EC and 2006/86/EC) came into force in 2006, setting mandatory standards for the procurement, processing, preservation, storage and distribution of human tissue for therapeutic use. This includes eye banking and the supply of ocular tissue for transplantation. The transposition of these EU directives into law is the responsibility of individual EU member states. There is still, however, a need for tissue-specific guidance from professional organizations such as the EEBA to provide more detailed advice not covered by the EU directives and, ultimately, to help improve standards for the quality and safety of tissues for human application. This book highlights the history and development of eye banking and all significant steps including the donation, processing and distribution of corneas for transplantation. Additional contributions on the sclera, amnion and retinal pigment epithelium provide further insights into ocular surgery and the future potential for transplantation. This book contributes the essentials in eye banking activities for ophthalmologists and eye bankers as well as for regulatory and legislative authorities. Timm Bredehorn-Mayr, Gernot I.W. Duncker, Halle (Saale) W. John Armitage, Bristol XI