Background: Vigilance philosophy
WHO promotes the governance of Medical Products of Human Origin (MPHO) in a manner that acknowledges their exceptional nature. From donation to the follow-up of the recipient, MPHO have a shared exposure to the risk of breaches of ethical standards; they also share risks to safety, in particular those posed by transmissible diseases. Vigilance is a powerful tool for improving safety and quality. 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. Detection, investigation and communication of adverse outcomes brings the transparency and openness that these particular medical treatments demand. To ensure the protection of the donor, the recipient and society will require the establishment of globally consensual principles to govern the use of medical products of human origin, such as the non-commercial nature of the human body and its parts, and strict traceability associated with vigilance and surveillance.
The Notify Library is the first WHO initiative that covers the full MPHO scope.
Objective of the Notify Library
The Notify Library is a joint global initiative, co-sponsored by the World Health Organization (WHO) and the Italian National Transplant Centre (CNT) as its Collaborating Center, that supports the sharing of published vigilance information for teaching purposes and for greater public transparency on the use of MPHO. The library aims to be comprehensive, describing all types of reactions or events that might have teaching value and assist in the estimation of risk.
The Notify Library is a publically accessible database of adverse outcomes collected and analyzed by dedicated editorial groups of international experts, regulators and clinicians. The database is not a vigilance reporting programme but a collection and review of information identified primarily by literature review (published articles in scientific journals and/or books) although case reports from regulatory or professional vigilance programmes (grey literature) are also considered for inclusion. For each adverse occurrence type, at least one reference source is cited and the project’s collaborating international experts provide a structured analysis.