Abstract: Objective Monitoring of adverse events related to medical devices is an important means of post-marketing risk management of medical devices. The purpose of this study is to analyze the correlation of adverse events related to medical devices in Shandong Province in 2012 based on the Apriori algorithm. Methods A descriptive analysis was conducted on 63 041 adverse injury events reported by monitoring institutions in Shandong Province in 2021, which were classified into three categories based on the classification of generalized medical devices, including passive medical devices, active medical devices and in vitro diagnostic reagents. The Apriori model for association rule mining was used to investigate the risks associated with adverse events related to medical devices by mining the device category, department of use, hospital category, use of expired devices, and the region to which the reported hospital belonged. Results Of the 63 041 adverse events, 20 564 were related to active medical devices, 42 181 to passive medical devices, and 296 to in vitro diagnostic reagents. As for the adverse events related to passive medical devices, the city, department and hospital which had the most adverse events were Yantai(n=5 711), operating room(n=835), and secondary general hospitals(n=5 320). As for the adverse events related to active medical devices, the city, department and hospital which had the most adverse events were Jinan(n=2 271), operating room(n=196), and tertiary general hospitals(n=1 108). As for the adverse events related to in vitro diagnostic reagents, the city, department and hospital which had the most adverse events were Yantai(n=42), the pediatric department(n=6), and primary hospitals(n=42). According to the association rule, the use of unexpired passive devices in health centers among primary hospitals received the most support, while for the use of expired devices, the most support was found in the use of active devices in the intensive care units of tertiary general hospitals in Rizhao. Conclusion The occurrence of adverse events is strongly associated with hospitals and departments at all levels, and similar problems also exist in the use of expired products. Our findings provide references for monitoring units and medical institutions to impprove the management of medical devices.

Key words: Data mining, Association analysis, Apriori rule, Medical device adverse events, Association rule mining