文章基本信息

标题：Pacemakers are not vacuum cleaners. Towards new guidelines for the introduction of novel medical devices in pelvic floor surgery
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作者：J. DEPREST ; D. DE RIDDER
期刊名称：Facts, Views & Vision in ObGyn
印刷版ISSN：2032-0418
出版年度：2011
卷号：3
期号：3
出版社：Universa Press
摘要：Our Belgian lay press recently became aware of the trend amongst medical professionals that the introduction of novel medical devices may need some more formal over- sight. For making that point, they were quoting from a de- bate during a cardiologist's meeting, with a one liner that the "requirements for bringing a new pacemaker or stent onto the market is from a regulatory viewpoint as simple as marketing a new vacuum cleaner" (Een pacemaker is geen stofzuiger. De Standaard, 1/9/2011, Figure 1). Patients would get scared for less !