EEBA Program (PDF/3MB) - EEBA - Annual Meeting

EUROCET 128: SUPPORTING THE IMPLEMENTATION OF THE EUROPEAN CODING SYSTEMFOR TRACEABILITY OF TISSUES AND CELLSA. Ghirardini¹, D. Fehily¹, P. Di Ciaccio, M. Mareri¹, F. Vespasiano¹, A. Nanni Costa¹, P. Ashford², R. Benedek³¹Italian National Transplant Centre, Italian National Institute of Health, Italy; ²ICCBBA, California, USA; ³ArtmanTechnologies sro., SlovakiaPurpose: The primary aim of Eurocet 128 is to support the traceability of human tissues and cellsintended for human application in patients in the European Union. From donation to transplantation,it is essential to maintain traceability so that the cells or tissues can always be linked back to theoriginal centre where they were procured and received and, indeed to their original human origin.Traceability of these substances across the EU will be improved by the implementation of a singleEuropean Coding System as required by Directive 2004/23/EC.Methods: The European Commission has awarded a contract to the Eurocet 128 consortium todeliver the tools required for the implementation of the Single European Code. The coding systemimplementation will be supported by the construction of two official public lists - the tissueestablishment compendium and the product compendium - and the provision of an online codetranslator.The first compendium will be a list of all authorized establishments that procure, receive,process, store and/or distribute tissues or cells for human application, with their EU identifyingcodes, a minimum data set and their real-time authorization status by activity and by tissue/cell type.The compendium is being constructed on the basis of the previous work of Eurocet (the Europeannetwork of the competent authorities for tissues and cells) project, which collects information onauthorized tissue establishments and their activities from the EU Competent Authorities. The secondcompendium will be a list of types of tissue and cell products with agreed descriptions and theirassociated codes. It will support the use of the international standard ISBT 128, EuroCode and existingnational systems by mapping these systems to their corresponding European Generic Code. Theonline application will be an electronic code translator that will translate alphanumeric codes totextual information, as well as textual information to alpha-numeric codes.Results: It will be mandatory for tissue and cell products distributed in the European Union to carrya European Identifying Code. The Single European Code is an alphanumeric code that includesinformation on the TE origin, the donation number, the product code, divisions and expiry date ina standardized format. The requirements to use the code will be established through an EU legalinstrument, together with requirements on data to be recorded by each tissue establishment. It isanticipated that the Single European Code will be required from 2014; the exact date will be specifiedin the legal instrument. Through the online application, tissue and cell professionals, clinical users andregulators will be able to insert the European Identifying Code and obtains the information related tothe tissue establishment and the product or vice versa.Conclusions: At the completion of the full implementation of this work, all tissues and cellsdistributed for clinical use in the European Union will have a standard Single European Code on theirlabel. This code will allow to rapidly identify the tissue establishment of origin and its status, andconsequently to trace back the path followed by this tissue. It will also enable common understandingof the tissue or cell product type. Tissue Establishments should be preparing for the implementation ofthis new standard.XXV ANNUAL MEETING OF THE EUROPEAN EYE BANK ASSOCIATION Zagreb, Croatia 18/19 January 2013 29