Research On Modeling Of Medical Device Adverse Event Emergency System

As a product of modern science and technology, medical devices have been widely used in the prevention, diagnosis, treatment and rehabilitation of the disease. Any medical device is not zero risk or absolutely safe, it brings us the intended use as well as there are some potential risks. Medical devices are licensed only after pre-market research and evaluation which state that the proportion of the known benefits and known risks is acceptable, but as to the overall product life cycle and scope of use, the assessment only draws the interim conclusion of the risk evaluation. Some of the long-term effects of low incidence or the actual frequency or extent of the actual risk, which can be found by a number of people after the product into the market a long period of time, therefore it is significant that to establish medical device adverse event emergency system, for the control and disposal of sudden, serious consequences of medical device adverse event. This paper has built up one framework, three systems by analyzing the background and characteristics of the medical apparatus and instruments adverse events,(one framework is refers to the "medical device adverse event emergency system framework, three system is “Emergency preparedness and early warning system”, “Emergency response system”, “Emergency recovery and inspection and evaluation system”, “Emergency preparedness and early warning system” is mainly referred to any preparation work done before the occurrence of adverse events in order to effectively deal with the adverse events of medical devices.”“Emergency response system” is through command and dispatch system feel free to communicate instructions and work deployment, to listen to the work report; t realization of grading, sub regional command scheduling relative strength and resources, provide fast,efficient and accurate information for decision-making; and through summarizing the working status information of the emergency teams to understand the work schedule and work progress of the various groups and the implementation of the instruction, the emergency plan and the implementation of the plan. " Emergency recovery and examination evaluation system” is through the analysis of the summary of the experiences and lessons of emergency treatment, the revised plan, as the crisis treatment to establish the integrity offiles; so as to provide references for the emergency plan evaluation and revision, emergency capability assessment; and the medical device adverse events caused by the loss, emergency resource depletion of timely and accurate field notes and post hoc analysis, so as to carry out after the compensation and make precautions work.This paper take "one framework,three systems" as a design principle, and also develop a set of practical medical device adverse event emergency. The operation result of the platform is shown the system can realize filing, evaluation, revising and summary and analysis of the emergency to deal with the whole process management of medical device adverse events, so as to effectively prevent and response to medical device adverse events.