The Construction And Empirical Research On The Using Quality Evaluation Index System Of Medical Device In Guangxi Medical Institutions

ObjectiveThe aim of the research is to make the Measures for Supervision and Administration of the Using Quality of Medical Devices which issued by the China Food and Drug Administration implement better,and build the using quality evaluation index system of medical devices.In order to verify the scientificity and feasibility of the evaluation index system,author conducted the empirical research.The research can provide a uniform standard for the examination of the using quality of medical devices in Guangxi,and provide a reference for other regions in China.MethodsThrough the literature research and focus group discussion method established preliminary evaluation index system of the using quality of medical device in Guangxi medical institutions,and curb the index system with the Delphi method.After the initial screening the index definite the weight coefficient of index with the expert grading method.Finally,we use the comprehensive scoring method to establish the using quality evaluation model of medical devices,and conduct an empirical study on 18 medical institutions.ResultsLiterature research method,focus group discussion method and Delphi method were used to set up the using quality evaluation index system of medical device in Guangxi,which includes 12 level-one indexes,including organization setting,management system,procure,check acceptance and other segments;32 level-two indexes,including training and learning on relevant laws and regulations,quality management staffs,procurement department,enterprise qualification material of the company and so on;44 level-three indexes,including the training content of laws,job responsibilities of staffs,procurement records,using records and so on.In the two rounds of expert consultation,the first round had 16 experts while the second round had 15 experts.The positiveness coefficient of the experts were respectively 93.75% and 100%,indicating that the experts had a relatively high positiveness.The authority degree of Delphi consultation expert was 0.824,displaying the high degree in expert authority.The weights of 12 level-one indexes were respectively: learning and training(0.0998),institution setting(0.0972),management system(0.0951),procurement(0.0979),check acceptance(0.0778),storage(0.0771),usage(0.0891),maintenance(0.0862),transfer and donation(0.0591),report of bad events(0.0982),spot check(0.0612),self-inspection(0.0771).Synthetical scored method was utilized to construct the evaluation model,which was used to score and rank the results of nine municipal-level and nine county-level hospitals in Guangxi.The empirical research shows that the using quality scores of medical device in the municipal-level hospitals were ranked as follows in codes successively : A4?A1?A7?A3?A6?A8?A5?A9?A2,while the county-level hospitals were ranked as B6?B2?B4?B7?B1?B5?B8?B3?B9.According to the overall result of the comprehensive evaluation model,it was visible that there were two excellent municipal-level hospitals and one excellent county-level hospital in the 18 hospitals,which were respectively A4,A1 and B6.There were five good municipal-level hospitals and five good county-level hospitals,which were respectively A7,A3,A6,A8,A5,B2,B4,B7,B1,B5.There was one medium municipal-level hospital and two medium county-level hospitals,which were respectively A9,B6 and B2.There was one poor municipal-level hospital and one poor county-level hospital,which are respectively A2 and B9.ConclusionThis research explored and constructed a scientific,rational and convenient using quality evaluation index system for medical device in Guangxi through theoretical analysis and statistical analysis of data.In the level-one indexes,the top three with highest weights were respectively: “training and learning”,“report of bad events”,and “procurement”,in which,“training and learning” had the highest weight,reflecting that the training and learning of relevant laws and regulations on medical device were the key in the using quality of medical device.On-the-spot investigation results showed that the evaluation indexes are good,and can distinguish basically county as evaluation index of the using quality of medical device in Guangxi medical institutions.