The conference site.
In order to comprehensively evaluate the quality of medical device adverse event reports in Xiangtan City, and to detect and control medical device safety risks in a timely manner, on February 22, Xiangtan City Market Supervision and Administration Bureau held a special work on the quality evaluation of medical device adverse event reports in the city Can. 14 medical device safety monitoring and evaluation experts from the Central Hospital, Xiangtan County People’s Hospital and other units participated in the evaluation.
This assessment has passed the National Medical Device Adverse Event Monitoring Information System. From the 1026 report forms received by the city in 2021, 30% of the serious reports and 7% of the general reports will be selected. 158 reports were randomly selected for evaluation. Evaluation experts strictly follow the “Suspected Medical Device Adverse Event Report Form Quality Evaluation Scoring Standards”, and mainly evaluate the authenticity, accuracy, completeness and standardization of the report. Finally, the Municipal Adverse Drug Reaction Monitoring Center will conduct random checks. Reports are re-scored to ensure the accuracy of the assessment results. Judging from the evaluation results, the highest score is 100 points, the lowest score is 85.5 points, and the city’s average score is 96.31 points, reflecting that the overall quality of Xiangtan’s report is good.
In the risk discussion session, evaluation experts pointed out that the report has common problems such as lack of important information and incomplete process description. The application of the results puts forward positive and effective suggestions. At the same time, it is pointed out that it is necessary to focus on strengthening the attention and monitoring of high-value medical consumables, implantable medical devices, and centralized procurement of medical devices. (Correspondent Zhao Zheng)
Source: Hongwang Xiangtan Station
Author: Zhao Zheng
Editor: Chu Huang-Xiangtan Station