New French forms for adverse incident reporting:
This article was originally published in Clinica
Executive Summary
The French healthcare products safety agency, AFSSAPS, has published on its website updated adverse incident forms to be used by manufacturers when reporting incidents or near incidents to the competent authority. There are four separate forms designed specifically for reporting incidents with: disposables; implantable equipment; other equipment in general; and, specifically, reports on the rupture of ceramic heads on total hip implants. AFSSAPS states on its website that these forms are modified over time and that it is therefore important that manufacturers ensure they have the latest versions. The forms are available at: http://afssaps.sante.fr.htm/10/mv/1054c3.htm