Eurocet 128 has been a three year long Service Contract that the European Commission awarded to a consortium of 3 organisation which included the Italian National Transplant Centre (CNT), ICCBBA (the organization that manages the ISBT 128 standard) and a software company, Artman Technologies.
The Italian National Transplant Centre (CNT) is a technical body of the Ministry of Health. The CNT is the Italian Competent Authority (CA) of tissues and cells and acquired experience in the subject of this tender, leading a European project, called EUROCET, aiming at setting up a registry on organ, tissue and cell donation and transplantation activity shared by old and new European Member States (EU MS). Subsequently, EUROCET was officially endorsed by the EC to manage and host the EU Registry of Tissue Establishments (TEs) on the Eurocet website (http://www.eurocet.org). Moreover, CNT participated in the Working Group on Coding that was established by the EC’s Regulatory Committee for Tissues and Cells in 2006 .The network of Tissue and Cell CAs has been further strengthened by two further EU-funded projects coordinated by CNT. One developed guidance for inspection and vigilance of TEs; the second project, SOHO V&S (Vigilance and Surveillance of Substances of Human Origin), aimed at the development of common approaches to adverse event and reaction reporting and investigation for tissues and cells across Europe”.
“Artman Technologies is a software development company with offices in Bristol, UK, and Bratislava, Slovakia. They specialize in medical software and related technologies since 1991”.
The company used the expertise and experience obtained from the development of systems implemented previously to achieve a high standard of the application module, that allowed the conversion of alpha-numeric codes (tissue establishment codes, tissue and cells product codes) from/into detailed text. Fast responding application web pages, minimizing manual entry, maximizing drop down box entry selection, validations on the fly and logical sequencing – add on to overall user friendliness of the solution. Based on the access level users will be able to download both compendia in PDF format.
“ISBT 128 is the global standard for the identification, labeling, and information processing of human blood, cell, tissue, and organ products across international borders and disparate health care systems. The standard has been designed and perfected over a period of almost two decades to ensure the highest levels of accuracy, safety, and efficiency for the benefit of donors, patients, and health care professionals around the world. ICCBBA, a non-profit organization located in Redlands, California, USA, manages, develops and licenses ISBT 128”.
Eurocet 128 used the coding experience of ISBT 128 to build a compendium of tissue and cell’s products and their respective alphanumeric codes, that are now hosted together with the compendium of Tissue Establishments by the European Commission to support the implementation of the Single European Coding System for tissues and cells.
The ISS-CNT coordinated the Eurocet128 consortium and led the dissemination. The construction of the official EU list of authorized Tissue Establishments and their respective alpha-numeric codes has been facilitated by the work carried out by Eurocet in the past.
The consortium built the tools which support the traceability of human tissues and cells that are applied to patients in the EU through the implementation of a single European Coding System: the EU Tissue Establishment Compendium, the EU Product Compendium and a publicly accessible electronic code translator aimed at allowing users to immediately establish both the tissue establishment of origin and the EU description of the material. The Compendia and code translator have been provided to the European Commission for hosting and maintenance.
Eurocet128’s
primary aim was to support the traceability of human tissues and cells
that are applied to patients in the European Union.
Tissues and
cells such as corneas, heart valves, cord blood or bone marrow are used
in transplant procedures to repair or replace damaged tissue or cells.
Fertility treatment frequently involves the manipulation and
application of gametes, sperm or eggs, or embryos. In these fields, it
is essential to maintain traceability so that the cells or tissues can
always be linked back to the original centre where they were collected
and, indeed to their original human origin.
Traceability of these
substances across the EU will be improved by the implementation of a
single European Coding System (SEC) which was foreseen in Article 10 of
the Directive 2006/86/EC, and its structure has to incorporate the
information laid down in Annex VII of this Directive.
The format of the SEC has been established as follows:
The implementation was made possible through the construction of two official public compendia. The first, called the EU Tissue Establishment Compendium, is a register of all tissue establishments which are authorised, licensed, designated or accredited by the Member States’ competent authority or authorities and which contains the information about these tissue establishments. The EU Tissue Establishment Compendium was created by the consortium, after collecting all the data necessary. It then assigned Tissue Establishment Identifiers to accredited Tissue Establishments around the EU. In order to do so, Member State Competent Authorities provided information on each of their authorized tissue establishments, specifying the activities and substance types for which they are authorized. The compendium contains all the Tissue Establishments authorized/licensed by the national CA in each country. Moreover, the compendium includes information on the status (active, non-active, active with license conditions etc.) of the Tissue Establishment and the kind of activity (procurement, banking, processing, preservation, storage and distribution, import or export) for which the establishment has been authorized/licensed.
The second, called the EU Product Compendium, is the register of all types of tissues and cells circulating in the Union and the respective product codes under the permitted coding systems (EUTC, ISBT128 and Eurocode). The consortium worked at its creation by inviting all Member State Competent Authorities to submit lists of product descriptions that are nationally in use to allow them to be mapped to a high level generic list of EU product descriptions. The product code applied to a tissue or cell package must be present in the Product Compendium. Currently ISBT 128 and Eurocode are the only systems that are included in the compendium and are mapped to the European Generic Code.
An electronic code translator allows those who receive tissues or cells for human use to immediately establish both the origin and the EU description of the material.
For more information, please, check out the Questions & Answers giving Essential Information for Tissue Establishments on the Implementation of the Single European Code for Tissues and Cells.
The Tissue Establishment Compendium
Member State Competent Authorities will have secure access to the TE compendium and will be required to update it regularly and rapidly whenever a newly authorized TE has to be included and anytime the authorization of a TE has to be modified (revoked, suspended, updated).
Only National Competent Authorities will be able to insert and modify the TE information but the compendium will be publicly accessible and European Tissue Establishments should check that their information is correctly registered.
The Product Compendium
Tissue Establishments using a coding system accepted in the EU Product Compendia (ISBT 128 and Eurocode) will use the product code from their coding system in the SEC Product Sequence. These codes will be mapped to the appropriate EU Generic Code in the Product Compendium. Tissue Establishments that use a local coding system will need to map their local codes to the equivalent EU Generic Product and include the corresponding EU Generic Code in the SEC Product Sequence. Tissue Establishments that do not use product codes will need to map each product they distribute to the corresponding EU Generic Product, and include the corresponding EU Generic Code in the SEC Product Sequence. Should it be necessary to map a product which is not already included within the Product compendium, National Competent Authorities will have to ask the European Commission to add it.
Legislation and Guidance
An EU working group of Member State representatives has developed, together with the European Commission, a text that was proposed for adoption to provide the detailed legislative requirements supporting the implementation of the SEC. The text has been adopted within the Directive 2015/565 EU as amendment of the Directive 2006/86/EC.
User Guidelines have been developed by the consortium and have been reviewed by the Competent Authorities. They will be available, as soon as the tools will be publicly launched.