Viewing Risk Management and Control from the Retrieval and Analysis of Adverse Events of Medical Devices

With the continuous improvement of medical standards, medical devices have been widely used in the fields of disease diagnosis, prevention, monitoring, treatment and rehabilitation. Any medical device that has been approved for marketing is not absolutely safe. Only through continuous monitoring of medical device adverse events can adverse events be detected in a timely and effective manner and provide a scientific basis for regulatory authorities to take corresponding administrative measures for products with potential safety hazards. Avoid or reduce the recurrence of similar adverse events. At present, many countries and regions have established medical device adverse event monitoring systems, and regularly publish the collected adverse events for public retrieval (see the table for the retrieval sources of medical device adverse events in some countries). Knowing how to retrieve information on medical device adverse events in various countries and regions, and mastering the method of aggregate analysis of retrieved medical device adverse events is of great significance to improving the safety and effectiveness of medical devices.

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