医疗设备的风险管理与控制

Medical Devices Risk Management and Control

医疗器械的风险管理涵盖采买管理、实施过程的管理以及使用过程的维护管理。长期以来医院一直偏重医疗器械的采买以及应用,但却忽视维修和保养,致使医疗器械不正常的使用,品质安全有很大的风险。要想让医疗器正常运行,合理地为患者治疗,都应执行医疗器械维修、维护的风险管理和控制,最大程度地让器械设备实现自身的价值。

Risk management on medical devices includes acquisition management,implementation process management,and maintenance management during normal operation hours.Hospitals have been focusing on acquisition and applications parts in the past.However,minimal effort has been made in the device maintenance and service part.This can lead to abnormal usage of the devices which in turn can cause significant device quality and safety risks.As a result,risk management and control in device maintenance should be implemented to keep the medical devices operational.Such that they can serve patients well and their values can also be maximized.