The Tissue Fixation System: How obsolete and potentially dangerous technology continues to be ‘sold’

H. Dietz
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引用次数: 2

Abstract

Gynaecologists have been at the receiving end of much regulatory intervention in recent years, some of it inappropriate and heavy‐handed such as the recent ban on midurethral slings in the National Health Service, others appropriate and, if anything, occurring too late. Regulatory agencies have failed, and so have individual doctors and their organisations. An example of individual and systemic failure involves the Tissue Fixation System. It is an Australian story that is not yet widely known, which is why the author has decided to acquaint the readers of ANZJOG with the situation in this country, where the Tissue Fixation System was invented, manufactured and used on thousands of patients over a period of eight years before its manufacture, sale and export from Australia ended in 2014.
组织固定系统:过时和潜在危险的技术如何继续被“出售”
近年来,妇科医生一直处于许多监管干预的接收端,其中一些是不适当的和严厉的,例如最近在国家卫生服务中禁止尿道中吊带,其他适当的,如果有的话,发生得太晚了。监管机构失灵了,医生个人及其组织也失灵了。组织固定系统是个体和系统衰竭的一个例子。这是一个尚未广为人知的澳大利亚故事,这就是为什么作者决定让ANZJOG的读者了解这个国家的情况。在澳大利亚,组织固定系统在8年的时间里被发明、制造和使用在数千名患者身上,直到2014年澳大利亚停止生产、销售和出口。
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