After 3 years of hard and productive work, the EUSTITE project closed at the end of December 2009 with all of its objectives achieved. 

Inspection Guidance

The EUSTITE Inspection Guidance was used by the European Commission during 2009 as the basis for providing official EU guidance to Member States.  The most important elements of this guidance should be published in the form of an EU Decision on guidelines for inspections and control measures and on the training and qualification of inspections in the field of tissues and cells in the Official Journal of the European Union later this year. The remaining guidance has been edited by a DG SANCO working group of Member State representatives to become an Operational Manual for Tissue and Cells Competent Authorities. This Manual is currently being translated by the European Commission into all of the official languages of the EU. The EUSTITE Inspection Guidelines will not be revised and re-issued but will live on in these official EU documents! 

Inspector Training

The project ran 4 inspector training courses, each including a 7-week e-learning module and a 3 day residential module. Seventy one inspectors were trained from 26 of the 27 EU Member States and feedback from course participants was extremely positive. However, demand for the course was much greater than the number of places available and at the end of the project there is still a substantial waiting list of applicants.  The trainees and facilitators from the 4 courses remain in contact with each other on an internet forum provided by the University of Applied Sciences in Vienna and discussions within this network continue to be lively and stimulating.  It is hoped that funding can be identified to facilitate the running of further editions of this course in the future.

Vigilance and Surveillance

Under the leadership of WHO, the project developed a series of vigilance tools for tissues and cells which were tested in a one year pilot with the participation of 22 Competent Authorities for tissues and cells.  The pilot report can be downloaded here. The criteria for the reporting of serious adverse events, the imputability scale for evaluating the link between a reaction and the tissues and cells applied and the severity scale for a reaction have all been incorporated into the guidance provided by the European Commission to Member States for the completion of their annual vigilance reports to the Commission.  The project submitted Final Vigilance Recommendations (click here to download) to the Commission which highlighted a number of areas for further work, particularly in relation to the need for investigation guidance and training, guidance for vigilance in Assisted Reproduction and the investigation of illegal and fraudulent activity and for greater engagement of clinicians to ensure effective vigilance.  These issues are now being taken forward in a new EU-funded project, Vigilance and Surveillance of Substances of Human Origin (SOHO V&S), which started in March 2010 and is also led by CNT in Italy (www.sohovs.org).

EUSTITE Final Conference

In December 2009, the Polish partner hosted a major conference where all of the work carried out was presented.  The journal Cell and Tissue Banking has agreed to publish a special supplement with articles covering all of the topics presented and discussed in Poland.  The supplement should be published later this year and will provide an excellent overview of the work of this very successful project.  Many thanks to the European Commission for supporting the EUSTITE project and to all of those in Europe and beyond who contributed to this work!