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法国式起搏器监测:早期检测永久性起搏器故障批次的尝试

Pacemaker surveillance "à la francaise": an attempt to detect faulty series of permanent pacemakers at an early stage.

作者信息

Welti J J

出版信息

Pacing Clin Electrophysiol. 1978 Jul;1(3):342-4. doi: 10.1111/j.1540-8159.1978.tb03489.x.

Abstract

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.

摘要

直到目前,法国的植入式心脏起搏器一直不受政府监管,因为人们担心不合理的管控会干扰这种新治疗方式的发展。医生只能自行选择看起来最可靠的设备,患者也能立刻从每一项制造工艺和技术进步中受益。尽管有这些优势,但缺乏限制和监管也有一个严重的弊端——没有政府机构来确保制造商将不可靠的心脏起搏器告知医生,而且一旦制造商发现问题,它可能会在最具商业时机的时候,而不是对患者来说最早、最安全的时间通知医生。出于这个原因,几位医生决定分享他们使用心脏起搏器的经验。这个人数逐渐增加,直到他们能够建立一个心脏起搏器监测和报告系统,该系统有能力尽早检测出有缺陷的心脏起搏器型号。这个心脏起搏器小组的中心位于巴黎的费尔南·维达尔医院,由法国心脏病学研究与互助协会(A.R.E.C.)以及法国心脏病学会的心脏起搏器小组赞助。

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