A European coding system for tissues and cells

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A European coding system for tissues and cells

• 25 March 2009
• Dr Stephen J Wicks

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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

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Why is traceability important?

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

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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

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Obligations requirements for EU
Coding
Traceability
EUROPEANCOMMISSION
SHALL ESTABLISH
The traceability requirements for tissues and cells, as well as for products and materials coming into contact with these tissues and cells and having an effect on their quality and safety (D.2004/23/EC, art. 8, 5 c.) ... the procedures for ensuring traceability at Community level (D.2004/23/EC, art. 8, 6 c.)
EUROPEANCOMMISSION
SHALL DESIGN
The Commission, in cooperation with the Member States, shall design a single European coding system to provide information on the main characteristics and properties of tissues and cells. (D.2004/23/EC, art. 25, 2 c.)
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Traceability
Robust Records
Robust Traceability
Robust Coding


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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
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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
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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

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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

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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

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The HTAs 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

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The HTAs 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/Tissu
  es_cells/

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www.hta.gov.uk