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:

自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。

其他：

FDA's Current Publications for Manufacturers of Medical Devices

FDA目前发布的医疗器械生产文件

In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. In the following, you will find a selection of the last 4 months.

ECA不定期地会公布FDA关于医疗器械的新指南或指南草案、培训、通用策略说明和检查结果的概览。在以下，你会看到最近4个月的情况。

In a detailed report made of 34 pages, the FDA explains its role in ensuring American patients have access to safe and effective medical devices. The report considers changes over the past five years.

在一份34页的详细报告里，FDA解释了其在确保美国患者使用安全有效医疗器械的方面的职责。报告考虑了在过去5年中发生的变化。

The FDA presents in 143 pages very extensively its recommendations for a national assessment system for medical devices. Among other things, it aims to build a bridge between research and clinical application.

FDA在143页中大量说明了其对医疗器械的合理评估系统建议。在其它内容中，其目的是在研究和临床应用中建立起一座桥梁。

We have already informed about the CDRHLearn in our News. Here again, new modules have been added to the respective webpage where presentations and slides of FDA representatives can be seen. Modules on post-market activities and on workshops about "Purchasing Controls", process validation as well as on CAPA have been newly added.

我们已经从我们的新闻中知道了CDERHLearn。这里，又将新的模块添加进了相应的网页中，其中可以看到FDA代表的演讲和幻灯。关于上市后销售行为和“采购控制”培训、工艺验证、以CAPA的模块被新增加了进去。

A very specific guideline draft entitled "General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff" deals with the topic of animal testing in the course of the development of medical devices.

特定指南草案题为“医疗器械的动物研究中通常考虑”是关于医疗器械研发中动物测试的主题。

Within 34 pages, the very comprehensive guideline "eCopy Program for Medical Device Submissions" explains the handling of raw data in the course of electronic authorisations of medical devices.

在34页中，综合性指南“医疗器械申报的电子拷贝程序”解释了医疗器械电子批准中原始数据的处理。

【来源】Julia博客&GMP行业新闻

【整理】TACRO