Project NOTIFY

Vigilance and Surveillance

In September 2010 the NOTIFY Project was initiated as a joint venture by WHO and the Italian National Transplant Centre (CNT). In collaboration with the European SOHO V&S project a major global initiative was organized aimed at providing a global interface for the vigilance and surveillance of substances of human origin (organs, tissues and cells for transplantation and for assisted reproduction). Over 100 experts collaborated to gather documented cases of adverse reactions and events using published articles and vigilance system reports as their sources. The cases were used as the basis for developing draft guidance on detection and confirmation of reactions and events, with an emphasis on the key role of the treating physician.

A meeting of experts from 36 countries took place in Bologna from February 7th to 9th 2011 to explore the work already carried out and agree on priorities for the future development of global V&S for organs, tissues and cells.

The database of vigilance information collected by the Notify Project will be made publicly available on the WHO/CNT Global NOTIFY Library web site. This intent of this library is to provide a comprehensive reference to types of serious adverse events and reactions and their underlying root causes. The library will be maintained and updated and is intended as a communication hub for institutions and organizations worldwide collaborating in the facilitation of access to Vigilance and Surveillance information.

A further output of the project has been the development of a series of didactic papers. These address infections, malignancy, handling, characteristics and clinical errors, donor reactions and genetic transmission.

This ongoing initiative will facilitate global sharing of V&S information and guidance for the enhancement of donor and recipient safety and for greater public transparency in transplantation and assisted reproduction. It will also support the development of internationally common, or corresponding, terminology for vigilance of organs, tissues and cells.