4/4FDA公布醫(yī)療器械質(zhì)量量度測(cè)量指南的必要性QualityMetrics-RequiredforMedicalDevicestoo?質(zhì)量量度醫(yī)療器械也需要？Recently,theFDAhaspublishedadraftguidelineonthedeterminationofQualityMetrics.Withregardtomedicaldevices,theFDAisnowpursuingasimilarpath.Undertheheading"CaseforQuality"(CfQ),theFDAwouldliketoimprovethequalityofmedicaldevices.Afterhavingconductedtogetherwiththeindustryadetailedanalysisofqualitymetricswithregardtomedicaldevices,theFDAstarted2011CfQ.Atthattime,oneoftheoutcomesoftheanalysispointedoutthatcompanieswithacompany-widequalityorganisationreceivedfewercomplaints-bothinternalandexternal-andhadfewerqualitycostscomparedtotheirbusinessrivals.最近，F(xiàn)DA公布了一個(gè)關(guān)于質(zhì)量量度測(cè)量的指南。對(duì)于醫(yī)療器械，F(xiàn)DA現(xiàn)在想要采用類(lèi)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(duì)醫(yī)療器械進(jìn)行了詳細(xì)的質(zhì)量量度分析后，F(xiàn)DA開(kāi)始了2011質(zhì)量案例。在那時(shí)，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(jìng)爭(zhēng)對(duì)手，耗費(fèi)的質(zhì)量成本更少。Since2011thedeficienciesobservedbytheFDAduringinspectionshavebeenremainingconstantyearafteryear.TheWarningLettersstatisticsshowthesameoutcome.ThisisthereasonwhytheFDAnowwantstotakeadifferentpathwithintheframeworkofCfQinordertotakequalityenhancingmeasuresregardingmedicaldevices.Toachievethisgoal,theFDAplans3measures:自2011年以來(lái)，F(xiàn)DA在檢查中發(fā)現(xiàn)的缺陷保持?jǐn)?shù)年穩(wěn)定。警告信統(tǒng)計(jì)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(lái)提升醫(yī)療器械的質(zhì)量。為達(dá)到此目標(biāo)，F(xiàn)DA計(jì)劃采取3項(xiàng)措施：1.Focusonquality-concerningthispoint,thereareparallelstomedicinalproducts.(Quality)metrics-relevantformedicaldevices-shouldbeidentified.Inthemediumterm,thesevaluesshouldbeusedasrationalesinthecontextoffrequencyofinspection.OnecanseehereparallelstotheQualityMetricsInitiativeformedicinalproducts.關(guān)注質(zhì)量關(guān)于此點(diǎn)，有一些需要識(shí)別的與醫(yī)療器械相關(guān)的質(zhì)量量度類(lèi)似物。在中期，這些值應(yīng)被用來(lái)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.Involvementofstakeholders:Informativeandmeaningfulfeedbackshouldbeachievedthroughaclosecollaborationbetweentheindustry,hospitals,patients,etc.

干系人參與：通過(guò)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.Datatransparency:qualityrelevantdata-likee.g.recallsandinspectionoutcomeswhichmaybepublished-shouldalsobereleasedinanevaluableway.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(píng)估的方式進(jìn)行公布。Theseanalysesshouldenabletheindustrytoconcentrateontheareaswhichhavethestrongestinfluenceonproductqualityandthusonproductsafety.Thereby,metricsandsuccessfulqualitypracticesshouldbebroughttogethertoensurequalityenhancingmeasuresinthepatients'interest.這些分析可以促進(jìn)醫(yī)療器械生產(chǎn)行業(yè)集中精力在其對(duì)產(chǎn)品質(zhì)量具有強(qiáng)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(lái)確保質(zhì)量改進(jìn)措施，保證患者利益。

其他：FDA'sCurrentPublicationsforManufacturersofMedicalDevicesFDA目前發(fā)布的醫(yī)療器械生產(chǎn)文件Inirregularintervals,theECApublishesoverviewsovernewguidancesordraftguidances,webinars,generalstrategypapersandinspectionoutcomesoftheFDAwithregardtomedicaldevices.Inthefollowing,youwillfindaselectionofthelast4months.ECA不定期地會(huì)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(shuō)明和檢查結(jié)果的概覽。在以下，你會(huì)看到最近4個(gè)月的情況。Inadetailedreportmadeof34pages,theFDAexplainsitsroleinensuringAmericanpatientshaveaccesstosafeandeffectivemedicaldevices.Thereportconsiderschangesoverthepastfiveyears.在一份34頁(yè)的詳細(xì)報(bào)告里，F(xiàn)DA解釋了其在確保美國(guó)患者使用安全有效醫(yī)療器械的方面的職責(zé)。報(bào)告考慮了在過(guò)去5年中發(fā)生的變化。TheFDApresentsin143pagesveryextensivelyitsrecommendationsforanationalassessmentsystemformedicaldevices.Amongotherthings,itaimstobuildabridgebetweenresearchandclinicalapplication.FDA在143頁(yè)中大量說(shuō)明了其對(duì)醫(yī)療器械的合理評(píng)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。WehavealreadyinformedabouttheCDRHLearninourNews.Hereagain,newmoduleshavebeenaddedtotherespectivewebpagewherepresentationsandslidesofFDArepresentativescanbeseen.Modulesonpost-marketactivitiesandonworkshopsabout"PurchasingControls",processvalidationaswellasonCAPAhavebeennewlyadded.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(jìn)了相應(yīng)的網(wǎng)頁(yè)中，其中可以看到FDA代表的演講和幻燈。關(guān)于上市后銷(xiāo)售行為和“采購(gòu)控制”培訓(xùn)、工藝驗(yàn)證、以CAPA的模塊被新增加了進(jìn)去。Averyspecificguidelinedraftentitled"GeneralConsiderationsforAnimalStudiesforMedicalDevices;DraftGuidanceforIndustryandFoodandDrugAdministrationStaff"dealswiththetopicofanimaltestinginthecourseofthedevelopmentofmedicaldevices.特定指南草案題為“醫(yī)療器械的動(dòng)物研究中通常考慮”是關(guān)于醫(yī)療器械研發(fā)中動(dòng)物測(cè)試的主題。Within34page