Research And Design Of The Medical Devices Adverse Events Monitoring And Management System

As important tools of disease diagnosis and treatment,medical devices play an irreplaceable role in modern medical system.With the development of the medical device industry and science and technology in China,more and more leading technologies have been applied to medical devices.However,this brings new opportunities and challenges to medical device quality supervision in China.Monitoring of adverse events is an important component of medical devices quality supervision after the listing,and concerns the quality level of the devices and the devices using safety of people.In recent years,more and more government,industry and scientific research have been attached to the research on adverse event monitoring,guided by China Food and Drug Administration,regulators of all levels have set dedicated organs and information platform for medical device related adverse event monitoring,the gradual standardization of the monitoring,monitoring reported quantity increasing year by year,the increasing continuously research findings achieved some progress,but there are still some problems to be improved.This paper mainly focuses on some problems existing in the monitoring of adverse events,reviews the history and development of adverse event monitoring at home and abroad,analyzes the system flow of adverse event monitoring,discusses the relationship of adverse event monitoring,reevaluation and recall under the macro background of post-marketing supervision,analyzes the gaps and shortages of the current adverse event monitoring workflow in the new post-marketing supervision demand.In order to solve the problem of the lack of cross-domain workflow integration and coordination in the post-marketing supervision,based on the standards of YY/T0316 and YY/T1474,the author proposes an improved approach to the existing monitoring process,integrates risk management and usability engineering into the monitoring process so that it can be more fully dapted to the current adverse event monitoring.For the problems of data structurization,business and data standardization,the key risk analysis Pre-warning,the authors try to extend the existing monitoring process and include the requirements on recall and traceability of medical devices,use the standardized adverse event classification code,establishes a a special type of medical device risks analysis model and a general monitoring process oriented the whole life cycle of the product,and provides a further customizable basic process model for all kinds of monitoring staff and institutions other than using party.Taking the work flows of monitoring of adverse events established as the target requirement,the author designed and developed the corresponding monitoring information system and completed the corresponding testing work.During the development,MYSQL database is used as background database,and JSP technology is used to develop the front-end part of the system.User types of the system include medical device users,manufacturers and regulators,and the system modules include adverse event reporting,adverse event monitoring,adverse event reevaluation,recall,and so on.The above results are used as an open general tool or help to assist various monitoring workers to further enhance their monitoring capabilities and to jointly improve monitoring levels.