移动医疗器械终端产品质控技术研究

Study on the Quality Control Technology of the Terminal Products of Mobile Medical Device

移动医疗器械是有源医疗器械与移动互联网技术深度融合的产物,是医疗器械异军突起的新方向,是助推移动医疗服务、构建医疗健康大数据体系的重要基础。移动医疗器械的有效性和安全性的评价存在很多新的问题和挑战。如何解决这些质控技术问题,关系到新产品能否快速注册上市。本文讨论了目前移动医疗器械质控领域面临的几个突出的技术问题,包括反射式血氧、无创血糖、手机光辐射、柔性电池、柔性传感器等,对监管部门加强相关领域的质控工作给出了建议。

Mobile medical device originates from the integration between active medical device and mobile internet, and becomes a blooming branch of medical device industry. It is important basis to promote mobile health and construct medical big data system. The evaluation of effectiveness and safety of terminal products of mobile medical device is facing various challenges, which affects the registration period of these products. In this paper, several important technical issues on the testing of mobile medical device were discussed, including reflective oximetry, noninvasive glucose monitor, mobile optical radiation, fexible batteries and fexible sensors. Advice for corresponding departments to enhance related quality control was proposed.