Remarkable developments in the scientific, technical and medical fields have led to the increased therapeutic use of human organs, tissues and cells. Transplantation of these substances of human origin (MPHO) has not only saved lives but also improved the quality of life of individuals. These achievements have resulted, however, in a situation whereby the demand for organs for transplantation far outstrips the supply. In relation to tissues and cells for transplantation and assisted reproduction, the shortages are not as acute and generally patient needs can be met, with the possible exception of highly matched hematopoietic stem cells.
In spite of significant benefits derived from the transplantation of MPHO there is an inherent risk of disease transmission and /or a negative outcome. There are numerous reports in the literature concerning infectious disease, malignancy and other serious reactions that have occurred associated with donor to recipient transmissions for all MPHO.
The introduction of vigilance and surveillance systems can facilitate the monitoring of severe adverse occurrences and lead to improved measures for dealing with them as has been demonstrated with blood component transfusion and haemovigilance systems.
Recognizing the need for the surveillance of such occurrences, the World Health Assembly (WHA) in May 2010, called on the World Health Organization (WHO) to facilitate inter alia Member States’ access to ‘appropriate information on the donation, processing and transplantation of human cells, tissues and organs, including data on severe adverse events and reactions’.
In accordance with these resolutions, WHO, the Italian National Transplant Centre (CNT) and the EU-funded Project ‘Vigilance and Surveillance of Substances of Human Origin’ (MPHO V&S) joined forces to organize a major global initiative aimed at raising the profile of vigilance and surveillance (V&S) of substances of human origin. The initiative was called Project Notify.
The scope of the project included organs, tissues and cells for transplantation and for assisted reproduction. Ten working groups collaborated in the effort. The work was conducted on a WIKI site where over 100 participants (regulators, clinicians, professional society representatives, scientific experts) collaborated to gather documented cases of occurrences across the scope of the substances under consideration, using published articles and vigilance system reports as their sources. Over 1,900 published references were inserted on the site. The cases were used as the basis for developing draft guidance on the detection and confirmation of occurrences, with an emphasis on the key role of the treating physician.
The Notify project culminated in a meeting of 116 invited experts from 36 countries that took place in Bologna from February 7th to 9th 2011. The participants represented regulatory and non-regulatory government agencies, professional societies and scientific and clinical specialties from all WHO regions. The meeting was made possible with funds raised by CNT together with those allocated within the MPHO V&S project for an international meeting on vigilance reporting and investigation. The meeting explored the work already carried out on-line and agreed on priorities for the future development of global V&S for organs, tissues and cells.
From the meeting, the Bologna Initiative for Global Vigilance and Surveillance (BIG V&S) was established resulting in these outcomes:
- A detailed report of the meeting has been published .
- The MPHO V&S project has proposed instruments and guidance for tissue and cell V&S in the EU based on the outcomes of the Bologna Initiative.
- A new dedicated site has been established by CNT, as part of a sustained collaboration with WHO, for the promotion of V&S (www.notifylibrary.org). The ‘wiki’-style site
will support the global dissemination of information and references regarding adverse events and reactions that have been documented for organs, tissues and cells. It is publicly accessible and is populated initially with all of the documented incidents already collected in the Notify Google site.
These cases, and new cases as they arise, will be posted on the site using key words and a minimum data set which will enable searching by, for instance, type of humansubstance, type of infectious disease transmission agent, type of logistical error etc. The tool will be a source of information for clinicians, potential donors and patients who wish to better understand the risks associated with particular types of donation or human application; for professionals who need information when deciding on the suitability of a potential donor and for regulators who need information on previous experiences of specific types of reported events and reactions.
- An international Steering Committee, under WHO and CNT, with regulatory and professional representatives from the fields of organs, tissues and cells, has been established to oversee the work of the new website and to take forward the other outputs of the Bologna Initiative including the development of correspondence tables for terminology and agreement on common definitions, where possible.
WHO has published this document for clinicians as a reference to the guidance on detection and investigation of adverse occurrences that were developed by project Notify. The booklet will be provided to WHO Member States to promote V&S in transplantation.