A joint initiative co-sponsored by WHO, CNT and the MPHO V&S Project culminated in a Global Consultation on Vigilance of Organs, Tissues and Cells (for transplantation and for assisted reproduction) in Bologna, February 7-9 2011. A new open access, searchable website (a Vigilance Knowledge Base) has been established to host, maintain and update the library of documented occurrences that has been developed here (www.notifylibrary.org).
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 database 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. The database is organized:
By MPHO type
The database was built to cover occurrences related to different allograft materials: solid organs, cornea and eye tissue, tissues other than ocular and stem cells of various origins.
Each of these generated multiple occurrences relating to the specific system and then could be divided by type.
By Occurrence type
The various types of harm to recipients or donors were then classified by type such as: donor transmitted infections, including viruses, bacteria, fungi, parasites, prions, etc.; malignancies of all kinds; living donor reactions relative to organ donation, stem cell or bone marrow donation; and autologous tissue donations (excluding stem cells).
Occurrences implying a risk of harm were also classified depending on defined criteria:
- Loss of highly matched or autologous material
- Gamete or embryo mix-up
- Loss of suitable organ(s)
- Loss of large quantity of unmatched tissues or cells
- Unsuitable MPHO released for clinical use