医疗器械在临床整形治疗中的系统风险管理对策研究

Systematic risk management countermeasures of medical devices in clinical plastic therapy

目的:探讨医疗器械系统风险管理对策在临床整形治疗中的应用价值。方法:采用系统风险管理理论,从团队建设、平台监督、对象协同及数据管理等方面分析医疗器械风险因素,制定安全管理对策。选取医院烧伤整形科临床在用和前期试验的127台(件)医疗设备、手术器械和医用耗材,根据系统风险管理方法不同分为对照组和观察组,对照组采用非系统风险管理方法,观察组采用系统风险管理对策,每组各随机选取使用医疗器械的100例受试者或患者,自制满意度调查问卷对受试者或患者进行满意度测评,对比两组参与使用的管理团队业务水平考核成绩、使用数据管理效果、系统风险控制质量和整形受试及患者临床满意度。结果:观察组使用操作、技术保障、研究组织和管理辅助人员的业务能力考核成绩分别为(94.93±4.51)分、(89.54±4.75)分、(95.22±4.36)分和(87.53±3.96)分,均高于对照组,差异有统计学意义(t=6.079,t=4.862,t=4.258,t=5.424;P<0.05);观察组基础管理、整形治疗和临床试验数据的有效率分别为(97.52±1.89)%、(95.93±2.25)%和(98.53±1.04)%,均高于对照组,差异有统计学意义(t=5.276,t=4.409,t=3.952;P<0.05);观察组医疗设备、手术器械和医用耗材的系统风险发生频次分别为(1.58±0.27)次/月、(2.09±0.74)次/月和(0.53±0.31)次/月,均低于对照组,差异有统计学意义(t=4.784,t=5.127,t=6.275;P<0.05);观察组使用对象满意度为95%,高于对照组,差异有统计学意义(x^(2)=7.354,P<0.05)。结论:医疗器械系统风险管理方法可提升使用及管理人员业务水平,规范医疗器械临床使用数据质量,降低医疗器械系统风险,提高医疗器械临床服务质量。

Objective:To explore the application value of risk management countermeasures of medical device system in clinical plastic treatment.Methods:The risk factors of medical devices were analyzed from the aspects of team building,platform supervision,object collaboration and data management by using the theory of systematic risk management,and the safety management countermeasures were formulated.A total of 127 pieces of medical equipment,surgical instruments and medical consumables in clinical use and experiment in the department of burn and plastic surgery of the hospital were selected and divided into control group and observation group according to different systematic risk management methods.The control group mainly adopted non-systematic risk management,and the observation group was adopted systematic risk management countermeasures.Self-made satisfaction questionnaire was used to evaluate the satisfaction of subjects and patients.The professional level of the management team,the effect of data management,the quality of system risk control and the clinical satisfaction of plastic surgery subjects and treatment subjects were compared between the two groups.Results:The professional ability assessment scores of operational ability test scores of the staff of the operation,technical support,research organization and management support in the observation group were(94.93±4.51)points,(89.54±4.75)points,(95.22±4.36)points and(87.53±3.96)points,respectively,which were higher than those in the control group,the difference was statistically significant(t=6.079,t=4.862,t=4.258,t=5.424;P<0.05).The effective rates of basic management data,plastic treatment data and clinical trial data in the observation group were(97.52±1.89)%,(95.93±2.25)%and(98.53±1.04)%,respectively,which were better than those in the control group,the difference was statistically significant(t=5.276,t=4.409,t=3.952;P<0.05).The occurrence frequencies of systematic risk of medical equipment,surgical instruments and medical consumables in the observation group was(1.58±0.27)times/month,(2.09±0.74)times/month and(0.53±0.31)times/month,respectively,which were lower than those in the control group,the difference was statistically significant(t=4.784,t=5.127,t=6.275;P<0.05).The satisfaction of subjects in the observation group was 95%,which was higher than that in the control group,the difference was statistically significant(x^(2)=7.354,P<0.05).Conclusion:The systematic risk management method of medical devices can improve the professional level of personnel using and managing medical devices,standardize the quality of clinical use data of medical devices,reduce the systematic risk of medical devices,and improve the clinical service quality of medical devices.