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A European coding system for tissues and cells

A European coding system for tissues and cells. 25 March 2009 Dr Stephen J Wicks. Aims & outcomes. To explain why there is a need for a single coding system To provide the next steps in the process for introduction of the coding system. Why is traceability important?.

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A European coding system for tissues and cells

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  1. A European coding system for tissues and cells 25 March 2009 Dr Stephen J Wicks

  2. Aims & outcomes • To explain why there is a need for a single coding system • To provide the next steps in the process for introduction of the coding system

  3. Why is traceability important? • Dentist that had lost his licence to practice • Netted £ millions • More than 1000 New York bodies • No family consent • > 20,000 recipients • US, Canada, Europe, Japan & elsewhere • Bones, skin, arterial valves, ligaments, tendons • Safety and quality - no donor selection, difficulty in recall

  4. Traceability issues • Hundreds of tissues from a single donation • 7-8 organs • Tissue engineered products • International sharing of substances of human origin • Risk of disease transmission is not zero • Recovered, processed & applied in different countries • Adverse events/reactions – surveillance • Need for fast and efficient communication

  5. Obligations & requirements for EU Traceability Coding

  6. Traceability Robust Records Robust Traceability Robust Coding + =

  7. Recommendation • Made by the European Committee for Standardization (CEN) / Information Society Standardization System (ISSS) Workshop • Recommended use of ISBT 128 as the basis for the EU coding scheme • Globally unique donation product and ‘key’ codes Country ID + CA + TE ‘key code’ Globally unique Donation Code Globally unique Product Code

  8. ISBT 128 • Provides for unique identification of any donation worldwide • 13 character identifier No. of the donation assigned by the collection facility Checksum character Collection facility 05 G1517 07 600001 X Individual barcodes Year = 2007

  9. Coding system • Unique identification - underpins traceability • Represents product description, tissue establishment and processing information which facilitate: • product exchange • stock control • understanding of product for clinicians • integration of information in hospitals • analysis of outcome data by type of tissue or its attributes

  10. Coding system • Overcomes language barriers • Supports regulatory/ethical control • The Facility Identification Number provides a ‘licence plate’-- this may help reduce trafficking • Facilitates reporting requirements - TEs and CAs

  11. Coding system • Traceability and biovigilance links • Link all products relating to a single donor • Enable analysis of outcomes by type of processing, etc. • Support communication between differing software systems

  12. The HTA’s role • We are working with the European Commission and other member states to ensure that any coding system is • robust • meets the needs of Stakeholders • meets the needs of Competent Authorities • and that the implementation is proportionate

  13. The HTA’s role The HTA will issue further guidance and / or Directions when the detailed requirements of the European Coding System required by the parent directive are clarified by the European Commission. ftp://cenftp1.cenorm.be/PUBLIC/CWAs/e-Europe/Tissues_cells/

  14. www.hta.gov.uk

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