[Postmarketing surveillance in patients with cardiac pace-makers or automatic implantable defibrillators].
This article includes an overview of the actual French control and regulation system of the safety alerts involving pacemakers and implantable cardioverter-defibrillator and an evaluation of the general information and trends about the characteristics of the reported incidents obtained in the last years in that field. The national security agencies have the mission to collect the data on safety and efficacy of medical devices but manufacturers, physicians and patients also have a role to play. The technical appreciation of the necessity of a notification is not easy in some cases but the lack of notification of a severe incident may lead to heavy penal consequences. If doubtful cases, one should keep in mind the spirit of these safety systems: a collective insurance against the risks related to the use of medical devices. In the 10 last years, the annual advisory rate was increased. The pacemakers were recalled more frequently than implantable cardioverter-defibrillators in absolute value but less frequently in relative value (advisories per 100 person-years). This increase may be related to the growing number of device implants and expanding indications for device therapy, to the increasing sophistication of the devices and to the modifications in the regulation aspects of these problems with a closer attention of users and physicians to the several types of malfunctions.
Fauchier
L
L
Service de cardiologie B et laboratoire d'électrophysiologie cardiaque, centre hospitalier universitaire Trousseau, 37044 Tours cedex, France. lfau@med.univ-tours.fr
de Bouët du Portal
H
H
Giraudeau
C
C
Froger
S
S
Cosnay
P
P
Babuty
D
D
D003257:Consumer Product Safety; D017147:Defibrillators, Implantable; D005602:France; D006801:Humans; D010138:Pacemaker, Artificial; D011358:Product Surveillance, Postmarketing