Medical device industry: international investigation exposes lax regulation.
Medical device industry: international investigation exposes lax regulation.
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DOI：
10.1136/bmj.k4997
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发表时间：
2018-11-25
期刊：
影响因子：
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通讯作者：
Lenzer, Jeanne
中科院分区：
文献类型：
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作者：
Lenzer, Jeanne
今天发布了一项国际调查的结果，该调查追踪了未经充分测试或根本没有测试的医疗器械的危害。这项名为“植入档案”的调查由普利策奖得主国际调查记者联盟 (ICIJ) 牵头，由来自 36 个国家的 252 名记者进行，代表 59 个媒体合作伙伴，包括《英国医学杂志》和英国合作伙伴 BBC 和《卫报》。 这项调查受到荷兰调查记者兼广播公司 Jet Schouten 的启发，他领导了一次诱骗行动，说服了负责评估网状网络设备的被称为指定机构的私营公司。从一袋橘子中取出外科手术网。舒滕表示，这一结果让她希望对世界各地的设备审批情况进行调查。
The results of an international investigation tracking the harms of medical devices that have been tested inadequately or not at all are being released today. The investigation, called the Implant Files, was led by the Pulitzer prize winning International Consortium of Investigative Journalists (ICIJ) and conducted by 252 journalists from 36 countries representing 59 media partners, including The BMJ and UK partners BBC and the Guardian.The investigation was inspired by a Dutch investigative journalist and broadcaster, Jet Schouten, who led a sting operation by convincing the private companies called notified bodies that are responsible for assessing devices that mesh netting from a bag of mandarin oranges was surgical mesh. Schouten said that the results made her want an investigation into device approval around the world.