Construction Of Evaluation Index System For The Applied Situation Of Spring Coils And Surgical Electrodes

BackgroundWith the progress of science and technology and the improvement of people’s living standards,various types of medical devices are widely used in clinical.It plays an active role in meeting people’s health needs,as well as in the prevention,diagnosis and treatment of diseases.The effective and rational use of medical devices is important to reduce patients’pain,improve surgical safety and reduce the incidence of clinical adverse events.Medical devices such as spring coils and surgical electrodes play important roles in the treatment of intracranial aneurysms.However,due to the wide variety and complexity of the models of these two types of medical devices,China still lacks relevant studies to evaluate the specific use of these two types of medical devices in terms of effectiveness,safety and the occurrence of adverse events.Therefore,there is an urgent need to build a set of medical device use effect evaluation index system with spring coils and surgical electrodes as examples in China,to conduct a comprehensive evaluation of the safety,effectiveness and economy of the clinical use of spring coils type and surgical electrodes type medical devices,and to identify their existence or potential problems in a timely manner.This helps to detect and report adverse events in a timely manner and reduce the resulting adverse effects.ObjectivesIn this study,based on the product information of spring coil and surgical electrode class medical devices in Shandong Province,combined with literature research method,Delphi method and other research methods,the evaluation index system of the use effect of spring coil class and surgical electrode class medical devices is constructed.And conducted empirical study to verify the usefulness and scientific validity of the indicators.To provide a reference and theoretical basis for future evaluation of these two types of medical devices and improve the science and timeliness of these two types of medical devices regulatory work.MethodsThis study used the literature research method to sort out the research progress of medical device use effect evaluation and constructing medical device evaluation index system,as well as the policy documents issued by the State Drug Administration and other related departments to screen the evaluation indexes.Applying the key informant interview method to understand the perceptions of clinical users and medical device managers on the evaluation of the effectiveness of medical device use.Constructing a library of indicators for this study’s evaluation system in conjunction with focus group discussions.Th en using the Delphi method and hierarchical analysis,carry out two rounds of expert correspondence to revise and improve the index system and determine the index weights,the consistency test results are good.In the course of the empirical study,according to the constructed index system,a questionnaire was designed to evaluate the practicality and rationality of the index system by conducting a questionnaire survey on the use of medical devices of spring coil type and surgical electrode type in 8 departments of a hospital in Shandong Province.Results(1)This study is based on the principles of constructing the evaluation index system,based on seven evaluation dimensions:technical characteristics,clinical use safety,clinical treatment effectiveness,clinical use satisfaction,economy,appropriateness,and innovation,established a set of spring coil type medical device use effect evaluation index system containing 16 secondary indicators and 46 tertiary indicators and a set of surgical electrode type medical device use effect evaluation index system containing 12 secondary indicators and 34 tertiary indicators.(2)The weights of each indicator in the first,second and third level indicators were calculated by applying the hierarchical analysis,and the consistency test results are good.The weight of the first level indicators clinical use safety and clinical treatment effectiveness is large.(3)The evaluation index system for the use of spring coils and surgical electrodes was applied to 7 clinical departments and 1 management department of a hospital in Shandong Province.The best combined use of all types of spring coils were produced by A4 and A5 company,with a combined score of 226;B company produced the LM-A3 model of surgical electrode class medical devices with the best comprehensive use effect and a comprehensive score of 128.5 points.(4)Feedback the newly constructed index system for evaluating the effectiveness of the use of these two types of medical devices and the application results to the person in charge of the clinical department and the person in charge of the medical device management department,they believe that they are in line with the actual situation and the index system is scientific and practical.ConclusionsThis study has constructed an index system for evaluating the effectiveness of the use of medical devices of the spring coil class and surgical electrode class by using a combination of research methods such as literature research method,expert consultation method and panel discussion method.Its index sources are reliable,its expert consultation results are more authoritative and the indicators were selected to be representative.The empirical results show that the evaluation index system of the use effect of spring coil class and surgical electrode class medical devices constructed in this study are practical and can be used as a reference evaluation index system for evaluating the use effect of these two types of medical devices in Shandong Province,which has certain significance for promotion.