The Design And Implementation Of Tracebility System For Medical Instruments

The quality and safety of medical device products which are related to human life and health has caused wide public concern.But its high risk determines the necessity of establishing traceability system.At present,more and more strict supervision at home and abroad market industry has put forward higher requirements for high risk medical devices,which means that if there is no traceability mechanism,medical equipment enterprises in the future is likely to face market access barriers,lose the competitive qualification.The perfect medical device traceability system improve the enterprise brand reputation,control the quality and safety of medical devices,and facilitate the rapid and accurate recall of the problem products which has important theoretical meaning and application value.In this paper,traceability system for medical products which is designed and implemented based on radio frequency identification technology(RFID)not only provide the whole life cycle of product tracking and tracing function for enterprise users,but also support regulators' public traceability inquiry service.This paper mainly launches from the following four aspects:First of all,in order to fully understand the traceability requirements of medical device products,the whole lifecycle process,business process,traceability data and system functional requirements of medical devices are analyzed,and the traceability subjects and key traceability nodes are defined.Furthermore,as the medical device traceability criteria are not uniform,the unified traceability code rules of medical device products are designed,the relationship between product batches is analyzed,and the traceability information and content are determined,thus the formal definition of traceability model is given,and the forward tracing methods and reverse tracking methods are proposed to realize the traceability of medical device products.To solve the problem of heterogeneous traceability data collection,the lightweight RFID data collection middleware which can analyze,filter and deal with massive data collection is designed and developed.Additionally,based on the above analysis of traceability business and traceability models,the overall structure and software architecture of medical device product s traceability system are designed.In order to realize the acquisition and integration of business order data and RFID data,the function module of the traceability information collection subsystem is designed.And the function module of the traceability inquiry subsystem is designed to realize the traceability inquiry of the medical device products.In addition,the database is designed from three aspects in this paper,including the data interface,the entity relationship and the database table.Finally,based on the above analysis and design of traceability businesses and model,the traceability information collection subsystem and the traceability inquiry subsystem are realized,the function and performance of traceability system are tested.