风险管理在医院医疗器械管理中的应用效果及对管理质量的影响研究
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摘要
目的:探讨风险管理在医院医疗器械管理中的应用效果及对管理质量的影响。方法:选取医院在用的26个品种9800件医疗器械,根据管理方法的不同,将其分为常规管理组和风险管理组,每组4900件,常规管理组为2014-2015年使用的医疗器械,风险管理组为2015-2016年使用的医疗器械。记录并统计两组器械排列和摆放、器械规格和数量、附加物品放置和器件小部件完好情况,采用自拟问卷调查表对医疗器械管理过程中分类错误、功能不全、器械遗失、供应不足及器械损坏、供给及时度、收回及时度及包装质量等进行评估,比较两组管理效果和对治疗的影响。结果:风险管理组医疗器械排列和摆放、器械不同规格数量、附加物品放置和器件小部件完好率均高于常规管理组,其差异有统计学意义(x~2=5.993,x~2=6.036,x~2=7.931,x~2=6.025;P<0.05);医疗器械管理缺陷率低于常规管理组,其差异有统计学意义(x~2=6.936,P<0.05);管理后供给及时度、收回及时度及包装质量评分,均高于常规管理组,其差异有统计学意义(t=20.394,t=21.847t=16.481;P<0.05)。结论:风险管理方法用于医院医疗器械管理中效果显著,有助于提高医疗器械管理质量,降低器械差错率,确保医院医疗器械的安全使用。
Objective: To discuss application effect of risk management in medical device management of hospital and its impact on management quality. Methods: 9800 medical devices of hospital were selected and divided into routine management group(the corresponding medical devices came from the term of 2014 year to 2015 year, n=4900) and risk management group(the corresponding medical devices came from the term of 2014 year to 2015 year, n=4900) according to different management method. The arrangement and placement of device, the specification and quantity of device, the placement of accessories and the intact situation of widgets of the two groups were recorded and calculated as statistics method. A self-designed questionnaire was adopted to assess these situations included classification error, incompetence, loss of device, undersupply, instrument damage, the timeliness degree of supply, the timeliness degree of withdrawing and quality of packaging in the management process for medical devices. And the management effects of two groups and the corresponding influences of them for curative effect were further compared. Results: The arrangement and placement of medical device, the different specification and quantity of device, the placement of accessories, intact rate of widgets of risk management group were significantly higher than those of routine group(x~2=5.993, x~2=6.036, x~2=7.931, x~2=6.025, P<0.05). And the management defect rate of medical device of risk management group was significantly lower than that of routine group(x~2=6.936, P<0.05). And the scores of timeliness degree of supply, the timeliness degree of withdrawing and quality of packaging of risk management group post management were significantly higher than those of routine group(t=20.394, t=21.847, t=16.481, P<0.05). Conclusion: The effect of risk management that is used in medical equipment management of hospital is significant, and it contribute to improve the management quality for medical apparatus and instruments and reduce the error rate of instruments, and it can ensure the safety usage of them in hospital.
Objective: To discuss application effect of risk management in medical device management of hospital and its impact on management quality. Methods: 9800 medical devices of hospital were selected and divided into routine management group(the corresponding medical devices came from the term of 2014 year to 2015 year, n=4900) and risk management group(the corresponding medical devices came from the term of 2014 year to 2015 year, n=4900) according to different management method. The arrangement and placement of device, the specification and quantity of device, the placement of accessories and the intact situation of widgets of the two groups were recorded and calculated as statistics method. A self-designed questionnaire was adopted to assess these situations included classification error, incompetence, loss of device, undersupply, instrument damage, the timeliness degree of supply, the timeliness degree of withdrawing and quality of packaging in the management process for medical devices. And the management effects of two groups and the corresponding influences of them for curative effect were further compared. Results: The arrangement and placement of medical device, the different specification and quantity of device, the placement of accessories, intact rate of widgets of risk management group were significantly higher than those of routine group(x~2=5.993, x~2=6.036, x~2=7.931, x~2=6.025, P<0.05). And the management defect rate of medical device of risk management group was significantly lower than that of routine group(x~2=6.936, P<0.05). And the scores of timeliness degree of supply, the timeliness degree of withdrawing and quality of packaging of risk management group post management were significantly higher than those of routine group(t=20.394, t=21.847, t=16.481, P<0.05). Conclusion: The effect of risk management that is used in medical equipment management of hospital is significant, and it contribute to improve the management quality for medical apparatus and instruments and reduce the error rate of instruments, and it can ensure the safety usage of them in hospital.
引文
[1]郑骏,王吉鸣,吴韬,等.风险管理在医院医疗器械管理中的应用[J].中华医院管理杂志,2014,30(5):365-367.
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[6]Kotecha A.Risk management:how does patient management in ophthalmology compare with those of other medical disciplines?[J].Acta Ophthalmologica,2015,93(S255).
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[9]饶冬霞,庞明月,段闵,等.某医院复用医疗器械再处理中质量追溯系统的应用研究[J].中国消毒学杂志,2015,32(9):879-881.
[10]李学文,国鹏,孟令伶,等.失效模式与效应分析法在护理安全管理中的应用[J].中国医院管理,2016,36(12):83-85.
[11]李非,毕开顺.基于市场准入的《医疗器械监督管理条例》系统分析与评价[J].中国药学杂志,2015,50(24):2166-2169.
[12]周晶,叶祥,蒋学华.四川省医疗器械生产企业无菌和植入性医疗器械生产现况:31家企业调查分析[J].中国组织工程研究,2017,21(6):928-933.
[13]张会平,史广鸿,田真,等.风险管理在重症监护病房导管相关感染防控中的应用[J].中国感染控制杂志,2016,15(8):618-620.
[14]罗小芳,李柏洲,白旭.FMEA方法改进及其在技术创新风险管理中的应用[J].运筹与管理,2015,24(4):264-271.
[15]金磊,王新,吕晓玉,等.基于Java服务器的医疗设备风险管理系统的设计与实现[J].中国医学装备,2017,14(12):108-112.
[16]张萃鳌,任雪松,王亚新,等.PDCA循环管理联合根本原因分析法在Ⅰ类切口手术抗菌药物预防使用中的应用[J].中国药房,2015,26(17):2420-2422.
[2]姚利,左爱芳.风险管理在手术室医疗器械质量管控中的应用[J].中国医学装备,2017,14(9):40-42.
[3]Vandael E,Vandenberk B,Vandenberghe J,et al.Risk management of QTc-prolongation in patients receiving haloperidol:an epidemiological study in a University hospital in Belgium[J].Int J Clin Pharmacy,2016,38(2):310-320.
[4]Casiraghi A,FranzèS,Rocco P,et al.Risk management of in-hospital administration of anticancer drugs:impact of Raccomandazione14 from the Italian Ministry of Health[J].Tumori,2016,102(Suppl 1):2-6.
[5]李昱萱,唐昊,张和华,等.目标管理在医院医疗器械监管中的应用研究[J].中国医学装备,2016,13(3):120-122.
[6]Kotecha A.Risk management:how does patient management in ophthalmology compare with those of other medical disciplines?[J].Acta Ophthalmologica,2015,93(S255).
[7]张楠,索继江.加强医疗器械管理预防与控制医院感染[J].中华医院感染学杂志,2014,24(18):4645-4647.
[8]姚敏,谢甜芳.持续质量改进在外来器械管理中的应用[J].中华医院感染学杂志,2014,24(14):3622-3624.
[9]饶冬霞,庞明月,段闵,等.某医院复用医疗器械再处理中质量追溯系统的应用研究[J].中国消毒学杂志,2015,32(9):879-881.
[10]李学文,国鹏,孟令伶,等.失效模式与效应分析法在护理安全管理中的应用[J].中国医院管理,2016,36(12):83-85.
[11]李非,毕开顺.基于市场准入的《医疗器械监督管理条例》系统分析与评价[J].中国药学杂志,2015,50(24):2166-2169.
[12]周晶,叶祥,蒋学华.四川省医疗器械生产企业无菌和植入性医疗器械生产现况:31家企业调查分析[J].中国组织工程研究,2017,21(6):928-933.
[13]张会平,史广鸿,田真,等.风险管理在重症监护病房导管相关感染防控中的应用[J].中国感染控制杂志,2016,15(8):618-620.
[14]罗小芳,李柏洲,白旭.FMEA方法改进及其在技术创新风险管理中的应用[J].运筹与管理,2015,24(4):264-271.
[15]金磊,王新,吕晓玉,等.基于Java服务器的医疗设备风险管理系统的设计与实现[J].中国医学装备,2017,14(12):108-112.
[16]张萃鳌,任雪松,王亚新,等.PDCA循环管理联合根本原因分析法在Ⅰ类切口手术抗菌药物预防使用中的应用[J].中国药房,2015,26(17):2420-2422.