Introduction: The traceability of tissue and cells transplants is important to ensure a high level of safety for the recipients. With the final introduction of the Single European Code (SEC) in April 2017 in the EU a consistent system among all member states became mandatory. Methods: The regulations for the SEC on EU and national level were evaluated. An overview on the different parts of the SEC with detailed explanations is given. Our own experiences with the implementation of the SEC in our multi-tissue bank are reported in addition. Results: The implementation of the SEC in our multi-tissue bank could be successfully realized. However, it revealed a number of difficulties, especially the sterile labeling of certain tissue transplants and the complex update of the existing database. Conclusion: The introduction of the SEC has made a contribution to the safety of recipients of tissue and cells transplants through a system of comprehensive and transparent traceability. (C) 2017 S. Karger GmbH, Freiburg
机构:
Tampere Univ, Fac Med & Hlth Technol, Tampere, Finland
Dept Pathol, Fimlab Labs, Tampere, FinlandTampere Univ, Fac Med & Hlth Technol, Tampere, Finland
Vuorisalo, Antti
Haapaniemi, Teppo
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Dept Pathol, Fimlab Labs, Tampere, Finland
Univ Jyvaskyla, Dept Biol & Environm Sci, Jyvaskyla, FinlandTampere Univ, Fac Med & Hlth Technol, Tampere, Finland
Haapaniemi, Teppo
Kholova, Ivana
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Tampere Univ, Fac Med & Hlth Technol, Tampere, Finland
Dept Pathol, Fimlab Labs, Tampere, FinlandTampere Univ, Fac Med & Hlth Technol, Tampere, Finland