Investigation On The Current Situation Of Medical Device Quality Management In Guangxi Public General Hospital

Objective:with the deepening of China’s health and medical system reform,the continuous establishment and improvement of modern hospital management system has put forward more refined requirements for the management of medical devices in public hospitals.Purpose of this study is to investigate the domestic public hospital medical device management status and the new progress of medical device regulatory,understanding the difficulties facing the public hospitals in the medical equipment management,through visit and questionnaire survey,comprehensive analysis of the current guangxi secondary,tertiary public general hospital medical equipment used in the quality and the management of the status quo,Referred to the 《Regulations on the Supervision and Administration of Medical Devices》and 《Measures for the Supervision and Administration of the Quality of the Use of Medical Devices》,the existing problems were analyzed.In order to improve the implementation of the system in hospitals,scientific,forward-looking and operable suggestions for the continuous improvement of the quality of the management of medical devices were put forward.It provides a scientific basis for accelerating the working mechanism of implementing medical device management regulations at the hospital level,improving the overall level of medical device use quality management in public general hospitals in our district,and promoting the development of legal supervision of medical devices in our district.Method:(1)Literature research: through Chinese and English literature retrieval,searched relevant medical equipment management literature,fully understood the domestic and foreign policy,the direction of the supervision and administration of medical devices and the status quo of the use and management of medical equipment in Europe and the us,defined the concept of medical device quality management,and found that the domestic medical equipment use quality management problems.(2)SWOT-PEST analysis: From the political,economic,social and technical aspects,this paper explored the internal advantages and disadvantages,external opportunities and external threats of medical device management of public general hospitals in China,and constructed a SWOT-PEST medical device management model,which provided reference for the study of the use quality and management status of medical devices in public general hospitals in Guangxi.(3)Questionnaire: to establish the medical equipment use quality inspection table ",questionnaire,survey,guangxi in public hospitals in the medical equipment use and management of quality,combined with the medical equipment management quality assessment interview schedule,in-depth excavation of guangxi public hospital using the present situation of the quality management of medical equipment.(4)The mathematical analysis method: by using the method of descriptive statistics to collect public comprehensive hospitals of guangxi medical devices using descriptive analysis quality management status,combined with the chi-square test,comparative analysis of guangxi secondary hospital and tertiary hospital,found that whether there is a statistically significant between the two,the guangxi region of quality management of medical equipment used for comprehensive analysis and evaluation.Results:(1)From the perspective of the overall implementation of the system in Guangxi public general hospitals,the establishment of the quality management system for the whole process of the use of medical devices accounted for a relatively low proportion,only 66.67% of the investigated hospitals had been established;Only 47.06% of hospitals had complete medical equipment maintenance records;94.12% of hospitals have established adverse event reporting system;However,only 44 hospitals,accounting for 68.75% of the total,were able to conduct regular self-examination of medical devices with high risk.(2)Comparative analysis of the differences between tertiary and secondary comprehensive public hospitals showed that the number of tertiary hospitals(19)carrying out relevant medical device management laws and regulations training was better than that of secondary hospitals(12);In the implementation of the whole-process quality management system for the use of medical devices,Grade III hospitals(24)were better than Grade II hospitals(17).In the storage of medical devices,tertiary hospitals were better than secondary hospitals(21)in terms of storage area and zoning to meet the needs of product type and quantity(27),environmental temperature and humidity conditions(28).In the establishment of the use link system,29 level-III hospitals have established the use records of implanted and interventional medical devices,while only 22level-II hospitals are inferior to level-III hospitals.In the system establishment of maintenance,adverse event reporting and sampling test of high-risk medical devices,the implementation situation of tertiary hospitals is better than that of secondary hospitals.(3)There are problems in the use and management of medical devices at home and abroad to varying degrees.The medical device adverse event reporting system is not perfect.There are omissions and concealment of medical device adverse event in the United States,Canada,Australia and other countries,while the reporting subject of domestic medical device adverse event is not clear.False positives,omissions,incomplete reporting information and other phenomena affect the reporting rate of adverse events.Some hospitals have not yet set up adverse event reporting institutions and related responsible persons.The medical device management personnel’s business level is low;The whole process of the medical device quality management system is not perfect,there are loopholes;The procurement process is not transparent and lacks oversight mechanisms;Medical device risk management system has not been implemented.(4)Based on the comprehensive analysis of SWOT-PEST,the hospital has many advantages in the management of medical devices,and the management of public hospitals is relatively standardized;The expansion of the medical device industry gives hospitals more choices.The development of "Internet +" has promoted the construction of hospital informatization.However,the internal disadvantages are still obvious,hospital managers have not yet caused enough attention to the management of medical devices;Lack of effective assessment and supervision;Information construction is difficult to meet the current management needs;Insufficient management talent team,lack of cost awareness,etcConclusion:The results of the survey were compared with《The Regulations on the Supervision and Administration of Medical Devices》 and《 the Measures for the Supervision and Administration of the Use of Medical Devices》.The quality management level of the use of medical devices in Guangxi public general hospitals still needs to be improved,tertiary hospital and secondary hospital there are gaps in the part of the system implementation,in order to better promote guangxi medical equipment management of continuous quality improvement,To ensure the safety of patients with machinery,suggest standardize laws and regulations training mechanism,promote the construction of medical equipment management personnel,to strengthen the consciousness of medical equipment management,ensure that every link of medical equipment management system implementation,improve the quality of medical equipment management,promote the fine management of medical equipment,we will continue to improve the medical device adverse event reporting system,to ensure the safety of medical apparatus and instruments,strengthening supervision of power,Effectively improve the supervision and execution,and comprehensively improve the management level of the use of medical devices in public general hospitals in our district.