浅谈基层医院医疗器械不良事件监测体系建立

摘要

目的：建立完善医院医疗器械质量安全控制及不良事件监测体系，做到有效监测并及时干预，保证医疗器械在临床使用过程中的安全性。方法医疗器械在使用过程中除了发挥其主要功能外，也可能会引发安全事故。确保医疗器械使用的安全性是医疗器械管理和使用者必须要考虑的因素。为了防止在临床诊疗过程中发生医疗器械不良事件，医疗机构必须重视医疗器械的质量安全控制。结果加强医疗器械质量安全控制和不良事件监测，有效降低了医疗器械临床使用过程中的安全风险。结论医疗器械质量安全控制及不良事件监测体系的建立完善，可有效保证临床使用中的安全性。%ObjectiveTo establish and improve the system of medical equipment quality and safety control and adverse events monitoring, so that effective monitoring and timely intervention can be realized to ensure the safety of medical devices in clinical use.MethodsApart from its main functions, medical devices may also lead to accidents during the operating process. Ensuring the safety of medical devices are the major concern of managers and users of medical devices. In order to prevent the medical device adverse events in the clinical diagnosis and treatment process, medical institutions must pay attention to the quality and safety control of medical devices.Results Enhancement of the safety and quality control of medical devices and adverse events monitoring effectively reduced the security risk of using medical devices.ConclusionThe system of quality and safety control and adverse event monitoring of medical device, can effectively ensure the safety in clinical use.