Understanding Barriers to Medical理解医学的障碍

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1、UnderstandingBarrierstoMedicalDeviceQualityOct.31,2011ContentspageEXECUTIVESUMMARY3INTRODUCTION6METHODOLOGY7MACROTRENDSINTHEMEDICALDEVICEINDUSTRY9TRENDSINMEDICALDEVICEADVERSEEVENTREPORTSANDRECALLS11HOTSPOTSFORPATIENTRISK14QUALITYRISKEXTENTANDROOTCAUSEVARYBYDEVICETYPE17OPPORT

2、UNITIESFORIMPROVINGQUALITYWITHINTHEINDUSTRY22Operatingsystems23Managementinfrastructure25Mindsetsandbehaviors26PERSPECTIVESONCHALLENGESTOADDRESSINGQUALITYGAPS28IMPLICATIONSANDPOTENTIALAVENUESTOADDRESSCHALLENGES37CONCLUSION44EXECUTIVESUMMARYThisreportistheresultofaninitiative

3、launchedbytheUnitedStatesFoodandDrugAdministration(FDA),CenterforDevicesandRadiologicalHealth(CDRH),aspartofanefforttoassessandunderstandgapsinmedicaldevicequality.Theworkfocusesonmarketedproductqualityassurance,ratherthanpre-marketactivities.Itspurposeistoprovideaperspectiv

4、eonthestateofmedicaldevicequality,aswellasthechallengesandopportunitiesforimprovement.Theworkwasconductedwithinputfromseveralsources:interviewswithinternalandexternalqualityexperts;asetofblindedindustryinterviews,ascanofdatabases,relevantarticles,andconferences;andanoutsidep

5、resssearch.Theseinputsuncoveredseveralkeyfactsaboutmarketedmedicaldevicesaswellaspotentialcatalystsforqualityimprovement.1.Themedicaldeviceindustryhasenjoyedtremendousgrowthinbothrevenuesandthetechnicalcomplexityoftheproductsthatitproducesoverthepast10-20years.2.Seriousadver

6、seeventreportsrelatedtomedicaldeviceusehaveoutpacedindustrygrowthby8%perannumsince2001.13.Qualityriskisnotevenlydistributedacrosstheindustry.Thisreflectstheheterogeneityandcomplexityofthedevices,manufacturers,anduseenvironments.Cardiovascular,invitrodiagnostic(IVD),andgenera

7、lhospital/surgicaldevicesaccountfornearly60%ofadverseeventsreports.Only20ofthe1189activeproductcodesaccountfor65%ofallseriousadverseeventsreportsbetween2005and2009.4.Ananalysisofrootcausedatarevealsthatfailuresinproductdesignandmanufacturingprocesscontrolcausedmorethanhalfof

8、allproductrecalls.Therootcausesofqualityissuesaretiedcloselytodevicetype.Th