医疗器械使用错误的风险评估方法研究

当前医疗器械不良事件监测已成为上市后医疗器械风险管理的重要研究方向。使用错误是与医疗器械使用相关的潜在风险,其研究具有重要意义。本文针对医疗器械使用错误及其风险评估方法进行了一些探讨和研究,以期对医疗器械不良事件监测与评价工作有所帮助。

Study on the Risk Assessment Approach for Use Error of Medical Device

The research on medical device adverse events （MDAE） monitoring has become an important aspect of the post-marketing medical device risk management. Use error is a potential risk related to the use of medical devices, it is significant to study. The article analyzed the use error of medical devices and the approach for risk assessment, in order to be helpful to the medical device adverse event monitoring and evaluation.