Establishment of a medical device adverse event management system for hospitals.

BACKGROUND: The management of medical device adverse event (MDAE) is one of the most important aspects of improving medical quality and safety management. Nonetheless, hospitals still lack standardized and unified initiatives to improve MDAE management. METHODS: This study, thus, established a MDAE monitoring system on May 1 in 2011 for suspected adverse events and designed a hospital-based dynamic warning system, aiming to standardize the process of MDAE handling and provide real-time monitoring for MDAEs in a hospital. This system was used in the First Affiliated Hospital of Zhejiang University School of Medicine. Numbers and the compound growth rate of MDAE reports from 2010 to 2020 were compared to test the effectiveness of the MDAE monitoring system. Numbers of MDAE reported to the National Adverse Event Monitoring System were also compared over 2013 to 2020, due to the loss of data before 2013 after shutdown of the old system. Efficacy and usability of the hospital-based dynamic warning system was then verified by analyzing risk and warning levels of MDAEs in 2020. Descriptive statistics was used for data analysis in this study. RESULTS: Results showed that the compound annual growth rates of MDAE reports and those submitted to the National Adverse Event Monitoring System from 2013 to 2020 were 35.0% and 31.5%, respectively. A standardized management of MDAE with full participant, timely response and effective feedback was formed in the hospital by establishment of the MDAE system. CONCLUSIONS: This system effectively improved the monitoring level of MDAEs, helping to improve early detection, early warning, and early intervention of risk of medical device. This study may provide suggestions for medical institutions to establish a MDAE monitoring system, and may promote development of medical quality and safety management for hospitals to some extent.