RESUMO
The Italian National Transplant Centre (CNT) is coordinating with the Italian National Blood Centre (CNS) the Joint Action '!' (www.eurocet128.eu), already built the European Tissue Establishment and Tissue and Cell Product Compendia between 2011 and 2014 in order to provide European Member States with a tool which would grant traceability of tissues and cells at human transplant purpose across the European Union. The two compendia are available on an online platform hosted and managed by the European Commission.
RESUMO
BACKGROUND: In the last years, there have been increasing concerns about the safety and traceability of human tissues and cells in Europe. In order to regulate this part of medical practice, the European Commission issued 3 directives between 2004 and 2006 and endorsed EUROCET to support member states in fulfilling some of their obligations. MATHODS: EUROCET created a connection with the European Union (EU) Competent Authorities (CAs) and set up a website where lists of the CAs, the authorized Tissue Establishments (TEs) and the activity data are published and updated. Moreover, EUROCET is involved within the Vigilance and Surveillance of Substances of Human Origin (SOHO V&S) project, aiming to support the EU member states in the establishment of vigilance and surveillance systems for tissues and cells. EUROCET is also working with EU stakeholders to develop a common coding system concerning donation and products. RESULTS: There are 33 countries in EUROCET and 57 CAs. 3,974 TEs are recorded: 1,108 for tissues, 1,480 for haematopoietic progenitor cells and 1,386 for assisted reproduction. On the website, it is possible to find the 2010 activity data report. CONCLUSION: Based on its cooperation with the CAs, EUROCET represents them in the European network. Nowadays, the EU member states can rely on a web portal and database in order to put the tissue and cell directives into practice.
RESUMO
CONTEXT: The high demand for organs for transplantation necessitates enhancement of organ procurement activity worldwide. OBJECTIVE: To detect critical areas in the organ donation process and to assess whether careful monitoring of deaths in each intensive care unit could improve rates of identification of brain death. DESIGN: Records of patients who died in intensive care units in the Emilia-Romagna region between July 1, 1998 and June 30, 2000 were reviewed through the Donor Action program. RESULTS: Of the 2469 patients who died during the period studied, 1010 (40.9%) had severe brain damage, as indicated by a score of 3 on the Glasgow coma scale. A total of 857 patients with severe brain damage who had spent more than 6 hours in the intensive care unit (34.7% of all deaths) were considered as potential donors. Signs of brain death were observed in 383 (44.7%) of the 857 patients who died. Rates of identification of brain death increased from 36% to 55% during the study period. CONCLUSION: Considering that the characteristics of the study population had not changed, we believe that the Donor Action program was an important factor leading to the observed improvement in identification of brain death.