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FDA公布医疗器械质量量度测量指南的必要性

2016年02月01日

Quality Metrics - Required for Medical Devices too?

质量量度---医疗器械也需要?


Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices. After having conducted together with the industry a detailed analysis of quality metrics with regard to medical devices, the FDA started 2011 CfQ. At that time, one of the outcomes of the analysis pointed out that companies with a company-wide quality organisation received fewer complaints - both internal and external - and had fewer quality costs compared to their business rivals.

最近,FDA公布了一个关于质量量度测量的指南。对于医疗器械,FDA现在想要采用类似的方式。在题为“质量案例”(CfQ)的文中,FDA想要改善医疗器械的质量。在与行业对医疗器械进行了详细的质量量度分析后,FDA开始了2011质量案例。在那时,分析结果之一指出具有全公司范围的质量组织的公司收到的投诉更少,包括内部和外部的,相比于其业务竞争对手,耗费的质量成本更少。


Since 2011 the deficiencies observed by the FDA during inspections have been remaining constant year after year. The Warning Letters statistics show the same outcome. This is the reason why the FDA now wants to take a different path within the framework of CfQ in order to take quality enhancing measures regarding medical devices. To achieve this goal, the FDA plans 3 measures:

2011年以来,FDA在检查中发现的缺陷保持数年稳定。警告信统计数据显示出相同的结果。这就是为什么FDA现在想要在CfQ的框架中采取不同的手段来提升医疗器械的质量。为达到此目标,FDA计划采取3项措施:


1. Focus on quality - concerning this point, there are parallels to medicinal products. (Quality) metrics - relevant for medical devices - should be identified. In the medium term, these values should be used as rationales in the context of frequency of inspection. One can see here parallels to the Quality Metrics Initiative for medicinal products.

关注质量----关于此点,有一些需要识别的与医疗器械相关的质量量度类似物。在中期,这些值应被用来确定检查频次的合理性。读者可以参阅“医疗器械质量量度倡议”。


2. Involvement of stakeholders: Informative and meaningful feedback should be achieved through a close collaboration between the industry, hospitals, patients, etc. 

干系人参与:通过医疗器械生产行业、医院、患者等之间的紧密协作,获得具有参考意义的反馈。


3. Data transparency: quality relevant data - like e.g. recalls and inspection outcomes which may be published - should also be released in an evaluable way.

数据透明度:质量相关数据---如可以公布召回和检查结果---也应以可评估的方式进行公布。


These analyses should enable the industry to concentrate on the areas which have the strongest influence on product quality and thus on product safety. Thereby, metrics and successful quality practices should be brought together to ensure quality enhancing measures in the patients' interest.

这些分析可以促进医疗器械生产行业集中精力在其对产品质量具有强大影响的领域,从而保证药品安全。因此,可度量的成功的质量规范应结合起来确保质量改进措施,保证患者利益。


Quality Metrics - Required for Medical Devices too?质量量度---医疗器械也需要?Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, ...