Vigilance, quality and health safety

Published on 22 January 2025

The Agence de la biomédecine is responsible for implementing vigilance systems in its areas of intervention, and for coordinating the national biovigilance system and the national MPA vigilance system, with a view to improving practices and controlling healthcare-related risks. Consolidated data, published in a dedicated medical and scientific report, are used to analyze the occurrence of undesirable events, improve practices and ensure patient safety.

Consolidated data on vigilance, quality and health safety

The medical and scientific report compiles data relating to incidents and adverse events occurring in the chain from harvesting and transplantation (organs, tissues, hematopoietic stem cells), to the collection and administration of breast milk for therapeutic use, as well as in medically assisted procreation and pre-implantation diagnosis activities.

These data, derived from declarations, vigilance measures and quality audits carried out by the agency, enable an in-depth analysis of undesirable events and risks associated with these activities. The medical and scientific report also contains vigilance, quality and health safety indicators developed by the agency to reduce risks, reinforce donor and patient safety, and improve practices.

The Agency analyzes these data and shares the information with healthcare professionals and the competent authorities concerned, the ARS and ANSM.

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