Problems And Countermeasures Of The Application Of Risk Management To Medical Devices In Hospitals

Object: Make people pay more attention to the application of risk management to medical devices in hospitals. Provide recommendations on administrative supervision of medical devices in use, and hospitals risk management for the government's and hospitals' considerations.Methods: Taking the advance character of this research into account, the collections of data in this paper mainly use methods like in-depth interviews with important insiders, literature collection etc. The mainly data analysis methods are comparative analysis and comprehensive analysis.Content: Introduce risk management, and risk analysis methods of medical device. Collect data on the medical devices management experiences of the United States, the EU, Japan, Canada, Australia and other countries. Do some research and come up with some common aspects of those countries.Implement system analysis to summarize the comprehensive situation of administrative supervision of medical devices in use, and hospitals risk management in China. Then come up with associated risk factors of medical equipments in use. In connection with the existing problems and risk factors of post marketed medical devices in China, make recommendations on how to strengthen the administrative supervision and hospitals risk management, for guarantee the safety use of medical devices. Finally, the further studies of the subject are presented.Conclusion: Although the postmarked medical devices management of the United States, the EU, Japan, Canada and Australia are just started. Those countries' experience has something in common on administrative supervision, implement way, government measures to monitor the use safety, and the regulatory system. The problems of safety use of post marketed medical devices of China are: the administrative supervision system need to be improved; hospitals have not pay enough attention the importance of medical device risk management; the maintenance of medical devices in hospitals need to be improved; there many problems exists in the detection of medical devices; the skills levels of clinical technical staff have big differences; because the lack of standard operative steps, mis-operations are not rare; lake of an information system to collect and manage the technical data of medical devices in use; because of the deficiencies of equipment insurance system, the medical risks to hospitals are real heavy burden. The risk factors of post marketed medical devices in China are: government monitoring system, hospital management, environment of equipment located, clinical technical personnel, the quality of equipments, patients and so on.Proposal: Strengthen the post marketed supervision of medical devices; make practice guidance of medical devices risk management for hospitals; strengthen the management functions of medical devices management department in hospital, and promote the implement of risk management; use risk analysis methods to identify the risk factors of medical devices in use; focus on essential security protective steps; build medical devices insurance system and develop third party companies to provide medical devices maintenance service; develop equipment evaluation index system, and make the detection be a process; improve the quality of personnel, to reduce the rate of human error; establish medical devices technology archives, it will be a base of quantitative management of medical devices in use.