Özet:

Abstract Introduction: Biovigilance presents a new opportunity for growth and improvement of the donation-transplantation process. Biovigilance is defined as the monitoring and control of procedures involving human cells, tissues and organs, from donation to the clinical evolution of the recipient and the living donor, in order to obtain and provide information on risks and adverse events, and to prevent its occurrence or recurrence. Objective: Describe biovigilance and transplant models and initiatives in Brazil and worldwide. Method: Narrative review of national and international literature on biovigilance and transplantation models in Brazil and worldwide. Results: The risk is present in all stages involving the donation-transplantation process, and implies continuous surveillance. Bio-surveillance initiatives around the world involve institutions such as the World Health Organization and Italy’s National Transplant Centre, which support the sharing of surveillance information published for teaching purposes and for greater public transparency and which, together with Member States of the European Union, aim to support the development and strengthening of the capacity to monitor and control quality, safety and effectiveness in this area. The Australian Government has an initiative that collects information on serious adverse events and reactions related to organ donation and transplantation, but it does not yet have an integrated surveillance system. Brazil, through its National Sanitary Vigilance Agency, has been monitoring the adverse events analysis, but that database needs to be integrated with that of the National Transplantation System. Conclusions: Having National efforts to address international initiatives with the World Health Organization is urgent, thus incorporating measures to implement a culture of quality and safety in the donor-transplant process, with innovative care modelling. It is also necessary to return back to society the high investments done in an efficient and effective manner.

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