Understanding Barriers to Medical

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1、UnderstandingBarrierstoMedicalDeviceQualityOct.31,2011ContentspageEXECUTIVESUMMARY3INTRODUCTION6METHODOLOGY7MACROTRENDSINTHEMEDICALDEVICEINDUSTRY9TRENDSINMEDICALDEVICEADVERSEEVENTREPORTSANDRECALLS11HOTSPOTSFORPATIENTRISK14QUALITYRISKEXTENTANDROOTCAUSEVARYBYDEVICETYPE17OPPORTUNITIESFORIMPROVING

2、QUALITYWITHINTHEINDUSTRY22Operatingsystems23Managementinfrastructure25Mindsetsandbehaviors26PERSPECTIVESONCHALLENGESTOADDRESSINGQUALITYGAPS28IMPLICATIONSANDPOTENTIALAVENUESTOADDRESSCHALLENGES37CONCLUSION44EXECUTIVESUMMARYThisreportistheresultofaninitiativelaunchedbytheUnitedStatesFoodandDrugAd

3、ministration(FDA),CenterforDevicesandRadiologicalHealth(CDRH),aspartofanefforttoassessandunderstandgapsinmedicaldevicequality.Theworkfocusesonmarketedproductqualityassurance,ratherthanpre-marketactivities.Itspurposeistoprovideaperspectiveonthestateofmedicaldevicequality,aswellasthechallengesan

4、dopportunitiesforimprovement.Theworkwasconductedwithinputfromseveralsources:interviewswithinternalandexternalqualityexperts;asetofblindedindustryinterviews,ascanofdatabases,relevantarticles,andconferences;andanoutsidepresssearch.Theseinputsuncoveredseveralkeyfactsaboutmarketedmedicaldevicesasw

5、ellaspotentialcatalystsforqualityimprovement.1.Themedicaldeviceindustryhasenjoyedtremendousgrowthinbothrevenuesandthetechnicalcomplexityoftheproductsthatitproducesoverthepast10-20years.2.Seriousadverseeventreportsrelatedtomedicaldeviceusehaveoutpacedindustrygrowthby8%perannumsince2001.13.Quali

6、tyriskisnotevenlydistributedacrosstheindustry.Thisreflectstheheterogeneityandcomplexityofthedevices,manufacturers,anduseenvironments.Cardiovascular,invitrodiagnostic(IVD),andgeneralhospital/surgicaldevicesaccountfornearly60%ofadverseeventsreports.Only20ofthe1189activeproductcodesaccountfor65%o

7、fallseriousadverseeventsreportsbetween2005and2009.4.Ananalysisofrootcausedatarevealsthatfailuresinproductdesignandmanufacturingprocesscontrolcausedmorethanhalfofallproductrecalls.Therootcausesofqualityissuesaretiedcloselytodevicetype.Th