Research On Evaluation Index System Of Manufacture Quality Safety For Aseptic Medical Device

This article, based on the characteristics of aseptic medical device manufacture process,aims to develop an index system, which can be used to evaluate the quality safety of the productsof the aseptic medical device manufacturing enterprises in our country. According to theevaluation results, the administration department could take different ways to supervise asepticmedical device manufacturing enterprises, distribute resources scientifically and reasonably, andwin the maximum effect during the supervision.Combining with experts consultation method and hierarchical analysis method, throughthe two rounds of the expert consultation, this paper will finalize index weight and the index at alllevels. Through the content analysis and depth interview method to make system preliminary draft,through the experts consultation method to screening and determine all levels of indexes. UsingEpidata3.1respectively by double to input survey data, through the SPSS16.0to analyse the datafrom consulting the experts.According to the principle and method of analytic hierarchy process, and the resultscomparing the importance of the same level relative to an index, to structure the judgment matrix.After that, by calculating the characteristic root of the matrix, make sure the relative weightbetween the same level index. Finally make sure the combination weights of the overall targetindex at all levels. As the authority coefficient of experts for the weight, with weighted averagemethod to calculate the combination weight, get the weights at all levels. Based on the indexessystem,construct comprehensive evaluation model for evaluating the aseptic medical devicesquality safety in the process.In this paper, the study shows the sterile medical device manufacturing enterprisequality management situation directly relates to the aseptic medical devices quality safety. So it attracts high attention both at home and abroad, and people make the various research.Constructing the production quality safety evaluation index system to evaluate the aseptic medicalequipment production quality safety conditions, is the effective method to promote enterprise theproduction quality management level and guarantee the quality and safety of aseptic medicaldevices. In the two rounds of expert consultation, the recovery of questionnaires both were100%,the mean differences of the authority coefficient of being consulted experts is0.82, and expertswho were selected have high enthusiasm and authority. According to the second round ofconsultation, index of the coefficients of variation of less than0.25reach88.5%, the index scorewere greater than0.7, the degree of concentration of the expert opinion on index is better, indexeshave been consistent approval. According to the results of the experts comparison of twoimportance, to calculate the weights of the index at all levels, see the text table4-11~table4-13.The result shows that combination of Delphi Method and AHP can be used to build upevaluation index system of manufacture quality for aseptic medical device. The index systemincludes four first-level indexes, namely Quality Management Requirements, ProductionEnvironment, Equipment&Facilities, Quality Control, and Quality Evaluation;23second-levelindexes and86third-level indexes. The index system, which covers the whole process elements ofthe quality management, can be used to evaluate the manufacture quality safety of aseptic medicaldevice.