[Reaction surveillance: organization in public care/hospitals in Marseille].
For the French Drug Agency (AFSSAPS), the aim of the reactovigilance is to monitor the adverse effects resulting from the use of IVD-MD. More precisely, the goal is to evaluate all incidents and risks that can result in inadequate results or negative effects to the user and therefore for the patient. According to the French Law and before the transposition in the French Law of the European Guideline 98/79/CE, the University Hospital of Marseille has decided to organize its own reactovigilance network. Since 2001, an institutional organization has been set up. For each of the 33 labs of the University hospital one reactovigilant has been nominated as well as one coordinating reactovigilant. Specialized structures have been created: one central committee and one experts group. Standardized operating procedures have been established. The reactovigilance system is also integrated to the vigilance coordination network of the Marseille University Hospital. This organization allows to achieve tracability of all alerts, as well as information and training for the professionals. Four missions are defined: collection and management of all incidents IVD-MD-related; diffusion of AFFSAPS and industrials alerts to all labs in order to take appropriate measures; Tracability of alerts and incidents in all labs and in central committee, tracability of reactives according to French guidelines (GBEA). For the first 10 months of 2002, 46 alerts have been forwarded to all lab's correspondants. In the same period, one real adverse event has been locally notified and after analyse will be forwarded to the AFSSAPS. All these factors should contribute to the health professionals interest and participation in reactovigilance activities.
Tardieu
S
S
Cellule évaluation médicale, Assistance publique-Hôpitaux de Marseille, 80 rue brochier, 13385 Marseille cedex 05. Sophie.tardieu@ap-hm.fr
Oddoze
C
C
Fuentes
A-M
AM
Gentile
S
S
Mendizabal
H
H
Pedrant
S
S
Sambuc
R
R
D003257:Consumer Product Safety / Q000592:standards*; D005602:France; D006761:Hospitals; D006801:Humans; D011634:Public Health