Monitoring of adverse events and incidents: the AMP Vigilance system.
In France, the surveillance system for assisted reproductive technology (ART surveillance) was recently established to monitor incidents involving gametes, embryos, and germline tissue used for therapeutic purposes or for fertility preservation, as well as adverse effects observed in gamete donors or in individuals undergoing ART. Launched in February 2007 with a pilot phase, the system was fully implemented following the publication of the June 2008 decree after the transposition of European directives. The Bioethics Act of August 2004 entrusted its implementation to the Biomedicine Agency. From February 2007 to the end of December 2010, 855 reports were submitted to the Biomedicine Agency: 70% were adverse events and 30% were incidents. In 78% of the reports, the events were serious adverse effects or incidents. Based on these results, the Biomedicine Agency recommended corrective and preventive measures and implemented specific initiatives to inform healthcare professionals and patients. Future challenges include raising awareness of the system, facilitating reporting, and providing feedback to healthcare professionals. (R.A.)
Author(s): Pariente Khayat A, Lemardeley G, Creusvaux H
Publishing year: 2011
Pages: 266-9
Weekly Epidemiological Bulletin, 2011, n° 23-24, p. 266-9
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