ABSTRACT
This chapter examines the role of local operators and clinicians responsible for implementing the medical device system on local level. It focuses on the obstacles and constraints local vigilance officers faced in their efforts to implement the medical device vigilance system in France under the auspices of French and European Union law. Hospitals appointed a local medical vigilance correspondent in consultation with the Medical Commission in public hospitals and the Medical Conference in private hospitals. The reconstruction of local operations is based on the information provided by medical vigilance officers in four hospitals grouped under the Assistance Publique-Hopitaux de Paris, the largest hospital group in Europe. For local officials, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS') silence was counterproductive and undermined efforts to motivate providers and hospitals to report incidents, which in turn encouraged underreporting. Vigilance work offered few rewards for local hospital staff and the whole process of medical device vigilance in their view was counterproductive.
