Risk Management Of Adverse Events Of Medical Institutions In Medical Devices

The hospitals focus on risk management of medical devices adverse event because of the high risk of medical devices. There were over1000patients dying from the "Bjork-Shiley" medical devices adverse event in American from1979to1986. Moreover,53women patients were badly injured in the "polyarcylamide hydrogel" medical devices adverse event in China from2000to2006. Therefore, how to discover timely and dispose effectively these risks in the process of medical service and improve the quality of medical service ceaselessly has become an important subject in hospital.This paper discussed on risk management of medical devices adverse event from the perspective of medical institutions. It based on the risk management of medical devices adverse event in hospitals as the research object, combining with the basic theory and analysis method of enterprise risk management. The paper used the research methods of literature research, questionnaire investigation, field research, comparative method and statistical method. Combining with the actual situation on risk management of medical devices adverse event in hospitals, according to process of the risk identification, risk assessment and risk control, this paper designed management process and management system of medical devices adverse event and provided useful reference for the risk management of medical devices adverse event in hospitals.Perfect management system and strict management process could improve the level of medical devices adverse event risk management in the hospital. Medical devices risk management could protect the patients. The risk management was significant for hospital to ease the tension between doctors and patients.