应用品管圈对提升可疑医疗器械不良事件上报率的探究.pdfVIP

RESEARCHWORK研究论著

应用品管圈对提升可疑医疗器械不良事件

上报率的探究

谢杲

宁波市鄞州区第二医院设备科，浙江宁波315100

[摘要]目的探究在可疑医疗器械不良事件监测工作中应用品管圈（QualityControlCircle，QCC）活动对不良事件上报率的

影响。方法成立QCC小组，对可疑医疗器械不良事件上报监测工作进行现状调查、目标设定、原因分析、对策拟定、对策

实施、效果确认、分析改进等内容的探究。对比实施QCC方法前后可疑医疗器械不良事件的上报数量及上报质量。结果实

施品QCC理方法后，可疑医疗器械不良事件上报率提升40%，明显高于实施前。结论采用QCC的管理方法，明显提升可疑

医疗器械不良事件上报率，有效提升可疑医疗器械不良事件监测报告的上报质量。

[关键词]医疗器械不良事件；品管圈；上报率；目标值

ResearchonImprovingtheReportingRateofMedicalDeviceReactionBasedon

theApplicationofQualityControlCircle

XIEGao

DepartmentofEquipment,TheSecondHospitalofYinzhouDistrict,NingboZhejiang315100,China

Abstract:ObjectiveToexploretheinfluenceofthequalitycontrolcircle(QCC)activityonthereportingrateofadverseeventsin

themonitoringofadverseeventsofsuspectmedicaldevices.MethodsAQCCgroupwassetuptoresearchontheinvestigate,the

status,targetsetting,causeanalysis,countermeasureformulation,countermeasureimplementation,effectconfirmation,analysisand

improvementoftheMDRmonitoring.ThedatabeforeandaftertheapplicationofQCCinthemonitoringofMDRwerecompared.

ResultsThereportingrateofMDRincreasedby40%aftertheapplicationofQCCinthemonitoringofMDR,whichwasobviously

higherthanbefore.ConclusionTheapplicationofQCCcansignificantlyimprovethereportingrateofMDRandeffectivelypromote

thedevelopmentofthemonitoringofMDR.

Keywords:medicaldevicereaction;qualitycontrolcircle;reportingrate;desiredvalue

[中图分类号]R197.3[文献标识码]A

doi：10.3969/j.issn.1674-1633.2019.04.039[文章编号]1674-1633(2019)04-0149-04

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