VIGILANCE GUIDANCE DOCUMENTS

EFRETOS was an EU-funded project that aimed to describe the optimal content of a European Transplant Registry, including an appropriate functional framework, a feasible technical approach and the organisational prerequisites. It also aimed to provide a comprehensive approach to safety issues related to organ transplantation, including the development of an organ vigilance system. The final project deliverable includes a section (chapter 10) on organ vigilance.

EUSTITE was an EU-funded project (2006-2009) led by the Italian National Transplant Centre in which the World Health Organisation participated.  In one of its work-packages, it conducted the first pilot programme of collecting and analysing adverse occurrences associated with tissues and cells used in transplantation and assisted reproduction in 20 EU Member States. Many of the cases evaluated in the pilot study have been inserted in the NOTIFY library.

SOHOV&S was an EU-funded project (2009 – 2012) that developed a number of guidance documents for vigilance and surveillance of tissues and cells for transplantation and for assisted reproduction.