[Research on the Whole-process Cloud Monitoring Mode of in Vitro Diagnostic Medical Devices Adverse Events].

ABSTRACT

OBJECTIVE: To improve the monitoring mode of in vitro diagnostic medical devices adverse events. METHODS: By discussing the objective laws of the characteristics, performances and causes of in vitro diagnostic medical devices adverse events, the key points of monitoring work were clarified. RESULTS: The whole-process cloud monitoring mode for adverse events of in vitro diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated. CONCLUSIONS: The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of in vitro diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.