European coding system for tissues and cells: a challenge unmet?
The Comité Européen de Normalisation (European Committee for Standardization, CEN) Workshop on Coding of Information and Traceability of Human Tissues and Cells was established by the Expert Working Group of the Directorate General for Health and Consumer Affairs of the European Commission (DG SANCO) to identify requirements concerning the coding of information and the traceability of human tissues and cells, and propose guidelines and recommendations to permit the implementation of the European Coding system required by the European Tissues and Cells Directive 2004/23/EC (ED). The Workshop included over 70 voluntary participants from tissue, blood and eye banks, national ministries for healthcare, transplant organisations, universities and coding organisations; mainly from Europe with a small number of representatives from professionals in Canada, Australia, USA and Japan. The Workshop commenced in April 2007 and held its final meeting in February 2008. The draft Workshop Agreement went through a public comment phase from 15 December 2007 until 15 January 2008 and the endorsement period ran from 9 April 2008 until 2 May 2008. The endorsed CEN Workshop Agreement (CWA) set out the issues regarding a common coding system, qualitatively assessed what the industry felt was required of a coding system, reviewed coding systems that were put forward as potential European coding systems and established a basic specification for a proposed European coding system for human tissues and cells, based on ISBT 128, and which is compatible with existing systems of donation identification, traceability and nomenclatures, indicating how implementation of that system could be approached. The CWA, and the associated Workshop proposals with recommendations, were finally submitted to the European Commission and to the Committee of Member States that assists its management process under article 29 of the Directive 2004/23/EC on May 25 2008. In 2009 the European Commission initiated an impact assessment on the Workshop proposals and recommendations. In the absence of an agreed pan-European direction various initiatives have continued work using, adopting or adapting their preferred, or existing, methods.
Reynolds
Melvin
M
AMS Consulting, Ross-on-Wye, UK. melvinr@ams-consulting.co.uk
Warwick
Ruth M
RM
Poniatowski
Stefan
S
Trias
Esteve
E
D001688:Biological Products / Q000191:economics / Q000592:standards / Q000600:supply & distribution; D003245:Consensus Statements as Topic; D018562:Disease Transmission, Infectious / Q000517:prevention & control; D001330:Electronic Data Processing / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D014015:Tissue Banks / Q000592:standards; D009927:Tissue and Organ Procurement / Q000191:economics / Q000592:standards*
D001688:Biological Products