Pacemaker surveillance "à la francaise": an attempt to detect faulty series of permanent pacemakers at an early stage.
Until the present, implantable pacemakers have not been subject to government regulation in France, as it had been feared that unreasonable controls would interfere with the development of this new form of therapy. Physicians were left to choose what seemed the most reliable device, and patients benefitted immediately from every manufacturing and technological advance. Despite advantages, the absence of restriction and regulation had a serious drawback--there was no governmental agency to ensure that manufacturers would inform physicians of an unreliable pacemaker, and once a manufacturer recognized a problem, it could inform the physician at the most commercially opportune time rather than the earliest, safest time for the patient. For this reason, several physicians decided to share their experiences with pacemaker function. The number gradually increased until they were able to set up a system of pacemaker suveillance and reporting which has had the capability of detecting defective pacemaker models at an early date. The center of this pacemaker group is at Hopital Fernand-Widal in Paris and is sponsored by the A.R.E.C. (Association de Recherche et d'Entraide Cardiologiques) and by the pacemaker group of the French Society of Cardiology.
D005602:France; D006801:Humans; D008722:Methods; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000592:standards*; D011786:Quality Control