Quality Metrics - Required for Medical Devices too?
質(zhì)量量度---醫(yī)療器械也需要？
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，F(xiàn)DA公布了一個關(guān)于質(zhì)量量度測量的指南。對于醫(yī)療器械，F(xiàn)DA現(xiàn)在想要采用類似的方式。在題為“質(zhì)量案例”（CfQ）的文中，F(xiàn)DA想要改善醫(yī)療器械的質(zhì)量。在與行業(yè)對醫(yī)療器械進行了詳細的質(zhì)量量度分析后，F(xiàn)DA開始了2011質(zhì)量案例。在那時，分析結(jié)果之一指出具有全公司范圍的質(zhì)量組織的公司收到的投訴更少，包括內(nèi)部和外部的，相比于其業(yè)務(wù)競爭對手，耗費的質(zhì)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年以來，F(xiàn)DA在檢查中發(fā)現(xiàn)的缺陷保持數(shù)年穩(wěn)定。警告信統(tǒng)計數(shù)據(jù)顯示出相同的結(jié)果。這就是為什么FDA現(xiàn)在想要在CfQ的框架中采取不同的手段來提升醫(yī)療器械的質(zhì)量。為達到此目標(biāo)，F(xiàn)DA計劃采取3項措施：
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.
關(guān)注質(zhì)量----關(guān)于此點，有一些需要識別的與醫(yī)療器械相關(guān)的質(zhì)量量度類似物。在中期，這些值應(yīng)被用來確定檢查頻次的合理性。讀者可以參閱“醫(yī)療器械質(zhì)量量度倡議”。
2. Involvement of stakeholders: Informative and meaningful feedback should be achieved through a close collaboration between the industry, hospitals, patients, etc.
干系人參與：通過醫(yī)療器械生產(chǎn)行業(yè)、醫(yī)院、患者等之間的緊密協(xié)作，獲得具有參考意義的反饋。
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.
數(shù)據(jù)透明度：質(zhì)量相關(guān)數(shù)據(jù)---如可以公布召回和檢查結(jié)果---也應(yīng)以可評估的方式進行公布。
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.
這些分析可以促進醫(yī)療器械生產(chǎn)行業(yè)集中精力在其對產(chǎn)品質(zhì)量具有強大影響的領(lǐng)域，從而保證藥品安全。因此，可度量的成功的質(zhì)量規(guī)范應(yīng)結(jié)合起來確保質(zhì)量改進措施，保證患者利益。
其他：
FDA's Current Publications for Manufacturers of Medical Devices
FDA目前發(fā)布的醫(yī)療器械生產(chǎn)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不定期地會公布FDA關(guān)于醫(yī)療器械的新指南或指南草案、培訓(xùn)、通用策略說明和檢查結(jié)果的概覽。在以下，你會看到最近4個月的情況。
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頁的詳細報告里，F(xiàn)DA解釋了其在確保美國患者使用安全有效醫(yī)療器械的方面的職責(zé)。報告考慮了在過去5年中發(fā)生的變化。
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頁中大量說明了其對醫(yī)療器械的合理評估系統(tǒng)建議。在其它內(nèi)容中，其目的是在研究和臨床應(yīng)用中建立起一座橋梁。
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.
我們已經(jīng)從我們的新聞中知道了CDERHLearn。這里，又將新的模塊添加進了相應(yīng)的網(wǎng)頁中，其中可以看到FDA代表的演講和幻燈。關(guān)于上市后銷售行為和“采購控制”培訓(xùn)、工藝驗證、以CAPA的模塊被新增加了進去。
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.
特定指南草案題為“醫(yī)療器械的動物研究中通常考慮”是關(guān)于醫(yī)療器械研發(fā)中動物測試的主題。
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頁中，綜合性指南“醫(yī)療器械申報的電子拷貝程序”解釋了醫(yī)療器械電子批準(zhǔn)中原始數(shù)據(jù)的處理。
【來源】Julia博客&GMP行業(yè)新聞
【整理】TACRO
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