In September 2010 the NOTIFY Project was initiated as a joint venture by WHO and the Italian National Transplant Centre. The project aims to promote and improve vigilance systems for the full scope of Medical Products of Human Origin (MPHO), including organs, blood, tissues, cells, gametes and embryos. The focus of the work has been the development of the NOTIFY Library (www.notifylibrary.org) , an open access database of reliably documented didactic cases of adverse occurrences arising with the clinical application of MPHO, from donation to follow-up of donors and recipients.
Cases are analysed, linked to their source reference (scientific publications, formal vigilance programmes) and regularly updated by editorial groups of international experts in the fields of transplantation, transfusion and assisted reproduction. The experts work in health authorities and professional societies across the globe and in all MPHO sectors. Expert analysis focuses in particular on how the adverse occurrence was recognised and how it is shown to have been associated with the donation, process or clinical application of the MPHO. Occurrences analysed include transmitted infections, malignancies, donor reactions, clinical complications and process associated incidents.
Sharing the lessons learned from adverse outcomes can allow significant process improvements for the greater protection of donors and patients. These benefits apply where the incident occurred but also anywhere else where an identical or similar incident might occur. The purpose of the NOTIFY Library is not to be a register of registries but to be a comprehensive tool, describing all types of reactions or events that might have didactic value and assist in the estimation of risk.
Apart from being an important tool for vigilance management, the library promotes good vigilance policy and practice for MPHO and is building a global network of experts that are learning from each other. All organisations, authorities or professional societies, that work on the safety and quality of MPHO are invited to support this didactic initiative by signing the attached statement of support.