Representative Zhang Haijun Proposes Optimizing Medical Device Adverse Event Management to Enhance Regulatory Efficiency

China Food and Drug News: During this year’s Two Sessions, Zhang Haijun, a deputy to the National People’s Congress and Chairman of Shandong Branden Medical Devices Co., Ltd., proposed optimizing the adverse event management mechanism for medical devices to further enhance the effectiveness of medical device regulation.

Representative Zhang Haijun stated that the “Administrative Measures for Monitoring and Re-evaluation of Adverse Events Involving Medical Devices” have further improved China’s adverse event management system for medical devices, effectively safeguarding public safety in the use of such devices. It is essential to further refine the adverse event management mechanism for medical devices and enhance regulatory effectiveness. Training should be strengthened to improve the awareness of relevant personnel regarding adverse events associated with medical devices. Training programs should be conducted for individuals and departments in healthcare institutions responsible for reporting adverse events, ensuring that reporters possess proficient knowledge of adverse events related to medical devices.

Deputy Zhang Haijun also recommended strengthening the performance evaluation of reporting personnel and operational departments. While ensuring that all adverse events involving medical devices are reported as required and that any suspicious cases are reported immediately, greater emphasis should be placed on report quality to improve accuracy. Furthermore, relevant institutions should be encouraged to regularly provide feedback on outcomes to reporters, thereby further enhancing the quality and efficiency of surveillance. This approach aims to shift the focus of adverse event monitoring from quantity to quality and tangible effectiveness. (By Feng Yuhao and reporter Man Xue)

《China MedicineCopyright of the Newspaper Office. Reproduction or use without permission is prohibited.

(Responsible Editor: Zhang Kexin)