Safety, quality and vigilance

The Agence de la biomédecine's mission is to promote the quality and health safety of activities within its remit. To this end, it implements two specific vigilance systems:

• Biovigilance concerns the monitoring of risks from harvesting to collection and therapeutic use of the following human body products: organs and tissues, hematopoietic stem cells and breast milk for therapeutic use.
• AMP vigilance covers the monitoring of risks associated with the collection and use of gametes (oocytes and spermatozoa) and embryos, as part of medically assisted procreation activities.

These measures require healthcare professionals to report systematically and without delay any serious incidents or unexpected adverse reactions linked to the various stages of the processes concerned: collection, preparation, transport, grafting, conservation, administration, etc. This reporting system is supplemented by active monitoring of expected adverse events, in order to measure their frequency and identify any worrying developments.

To carry out its vigilance mission, the Agence de la biomédecine :

• collects, evaluates and analyzes reports of incidents and adverse events submitted by local vigilance correspondents appointed in healthcare establishments and specialized centers, in order to identify potential risks associated with these activities and reduce their frequency and severity;
• produces regular reports and analysis tools for professionals, and conducts national or local surveys to enhance the quality and safety of practices;
• provides support for local vigilance correspondents, including appropriate training;
• supports healthcare establishments in their quality and risk management initiatives, through initiatives such as quality audits, or the development of tools such as professional recommendations, guidelines and best practice guides;
• works closely with European bodies, and actively participates in European projects to harmonize health vigilance practices on an international scale.

The Agence de la biomédecine has developed CARTOSAN, an interactive cartography of health alerts concerning the qualification of donors of human body products in its areas of intervention. This tool gives healthcare professionals quick and easy access to the recommendations issued by the Haut Conseil de la Santé Publique (French High Council for Public Health) and disseminated by the Agency on the pathologies at risk in the context of a donation, as well as the steps to take to ensure their safety. Accessible to all, professionals and patients alike, CARTOSAN contributes to greater transparency and information on these health issues.