Abstract
The EU Tissues and Cells Directive (2004/23/EC, 2006/17/EC, 2006/86/EC) (EUTCD) provides standards for quality and safety for all aspects of banking of tissues and cells for clinical applications. Commission Directive 2006/17/EC stipulates that the complete donor record with all the medical information is assessed for suitability before releasing tissues for clinical use. The aim of this study was to investigate the medical reasons for post-procurement donor exclusion, to identify the various potential sources for gathering information about donors’ medical and behavioural history and to evaluate their contribution to maximising the safety of donations. Information was collected from the Tissue Services (TS) records of 1000 consecutive deceased donors submitted to National Health Service Blood and Transplant (NHSBT) medical officers for authorisation for release for subsequent tissue processing and then for transplantation. Of the 1000 donors 60 (6%) were excluded because they did not fulfil the donor selection requirements of the EUTCD and NHSBT donor selection guidelines. The main reasons for medical exclusion were the presence of significant local or systemic infection in 32 donors (53% of those excluded for medical reasons) and a history of past or occult malignancy in 9 donors (15% of those excluded for medical reasons) which was not identified prior to procurement. The information leading to post-procurement exclusion was obtained from autopsy reports in 35 of the 60 excluded donors for medical reasons (58%) and from the general practitioner for 10 donors (17% of those excluded for medical reasons). In summary, careful evaluation of complete donor records reduces the potential risk of disease transmission by tissue allografts and ensures compliance with regulations and guidelines. The findings may lead to changes in donor selection policies with the aim of improving efficiency without compromising safety.
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References
American Association of Tissue Banks-AATB (2008) Standards for tissue banking, 12th edition
Archibald LK, Jernigan DB, Kainer MA (2002) Allograft associated bacterial infections-United States 2002. Morb Mortal Wkly Rep 51(10):207–210
Barbara J, Ramskill S, Perry K, Parry J, Nightingale M (2007) The National blood service (England) approach to evaluation of kits for detecting infectious agents. Transfus Med Rev 21(2):147–158
Beard J, Ireland L, Davis N (2002) Tissue donation: what does it mean to families? Prog Transplant 12(1):42–48
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Off J Europ Union 2006: 09/02/2006 L 38/40
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for coding, processing, preservation, storage and distribution of human tissues and cells. Off J Europ Union. 2006: 24/10/2006 L294/32
Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. 2004: 07/04/2004 L102/48
Eastlund T (2006) Bacterial infection transmitted by human tissue allograft transplantation. Cell Tissue Bank 7(3):147–166
Gocke DJ (2005) Tissue donor selection and safety. Clin Orthop Relat Res 435:17–21
Guidelines for the Blood Transfusion Services in the United Kingdom (2005) 7th Edition. London TSO (The Stationary Office). PO Box 29, Norwich, NR31 1GN. ISBN 0 11 703371 5, www.tsoshop.co.uk
Infection Surveillance Annual Report 2007 (2008) London. The NHS Blood and transplant and health protection agency (centre for infections). Accessed 5th May 2010 www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1227255714122
Lomas R, Drummond O, Kearney JN (2000) Processing of whole femoral head allografts: a method for improving clinical efficacy and safety. Cell Tissue Bank 1(3):193–200
Lutz B, Ratard R, Dodson D, Malecki JM, Morse AC, Weirsma S, Perrotta D (2001) Septic arthritis following anterior cruciate ligament reconstruction using tendon allografts- Florida and Louisiana, 2000. Morb Mortal Wkly Rep 50(48):1081–1083
Munro TR (1970) The relative radiosensitivity of the nucleus and cytoplasm of Chinese hamster fibroblasts. Radiat Res 42:451–470
Otero J, Fresno MF, Escudero D, Seco M, Gonzalez M, Peces R (1998) Detection of occult disease in tissue donors by routine autopsy. Transpl Int 11(2):152–154
Sugihara S, van Ginkel AD, Iiya TU, Van Royan BJ, van Diest PJ, Wuisman PIJM (1999) Histopathology of retrieved allografts of the femoral head. J Bone joint Surg (Br) 81-B:336–341
UK Blood transfusion and tissue transplantation services; Tissue donor selection guidelines—deceased donors (2007). Available at www.transfusionguidelines.org.uk accessed 5th May 2010
Van Wijk MJ, Visser L, Bokhorst AG (2008) Evaluation of autopsy reports before releasing musculoskeletal tissue donors; what is the benefit? Cell Tissue Bank 9:329–335
Wang S, Zinderman C, Wise R, Braun M (2007) Infections and human tissue transplants: review of FDA MedWatch reports 2001–2004. Cell Tissue Bank 8(3):211–219
Yates P, Thomson J, Galea G (2005) Processing of whole femoral head allografts: validation methodology for the reliable removal of nucleated cells, lipid and soluble proteins using a multi-step washing procedure. Cell Tissue Bank 6(4):277–285
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Chandrasekar, A., Warwick, R.M. & Clarkson, A. Exclusion of deceased donors post-procurement of tissues. Cell Tissue Bank 12, 191–198 (2011). https://doi.org/10.1007/s10561-010-9184-6
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DOI: https://doi.org/10.1007/s10561-010-9184-6