A joint initiative co-sponsored by WHO, CNT and the SOHO 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) was launched 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 transfusion, transplantation and assisted reproduction, 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 was built to cover occurrences related to the clinical application of different MPHO: organs, blood, cells, tissues, reproductive tissues and derived medicinal products (Figure 3). Each of these generated multiple occurrences relating to the specific system and then could be divided by type (Figure 4).
Figure 3. Notify Library - MPHO type taxonomy (extract). The comprehensive table is available in Annex 1.
Figure 4. Notify Library - Adverse occurrence type taxonomy (extract). The comprehensive table is available in Annex 2.
Occurrences implying a risk of harm were also classified depending on defined criteria:
- Loss (highly matched or autologous material, suitable organs, large quantity of unmatched MPHO)
- Mix-up (gamete or embryo mix-ups, incorrect MPHO applied)
- Unsuitable MPHO released for clinical use
- Wrong blood in tube - product not transfused