EUSTITE (European System for Inspections in Tissue Establishments)
Dec. 2006 – Nov. 2009
Main goal of the EUSTITE project is to revise the literature and to harmonize the standards and methodologies used for the inspections and the accreditation of tissue banks in European Union Countries, as foreseen by Directive 2004/23/CE, art.5, 6 and 7. In particular, the project aims to create common guidelines for all the Member States for the audits, and the development of a model program for the training of inspectors. Another important objective is the creation of standards for the classification of adverse events and reactions associated with quality and safety of tissues and cells. The guidelines for inspections of tissue banks have been recommended at the European level in order to implement the requirements of the EU Directive 2004/23. The tools developed for the classification of adverse events and adverse drug reactions have been included in the document drawn up by the Union for the reporting of SAR / SAE at Community level (Directives 2004/23 and 2006/86).
Bibliography. Fehily D, Delvecchio C, Di Ciaccio P, Ferraro C, Porta E, Bariani F, Villa E, Nanni Costa A, Hornez T, Brankov B, Noel L, Costello P, Garrido G, Cox M, Teskrat F, Kaminski A, Koller J, Kurz H, Witton M: “The Eustite project: working towards harmonised implementation of European regulation of tissues and cells”. Organs, Tissues and Cells 2007; 10(1): 31-36.
Fehily D, Kurz H, Hornez T, Teskrat F, Koller J, Brankov D, Noel L, Costello P, Masterson S, Garrido G, Alvarez M, Cox M, Kaminski A, Uhrynowska-Tyszkiewicz I, Davies T, Deguerra A, Jarabinska V, Delvecchio C, Porta E, Nanni Costa A: “The development of EUSTITE guidelines for the inspection of tissue and cell procurement and tissue establishments in the European Union” Organs, Tissues and Cells 2008; 11 (3): 167-174.