Factors associated with medical device-related sentinel events in Korea: A secondary analysis of the Korea Patient Safety Reporting & Learning System database

Purpose: This study aims to identify the factors associated with medical device-related sentinel events in Korean medical institutions and to provide information that can be used to support prevention strategies and institutional improvement.Methods: A secondary analysis was conducted using data reported to the Korea Patient Safety Reporting & Learning System from 2020 to 2024. Of the 84,263 reported safety incidents, 532 cases related to medical devices were analyzed. Descriptive statistics, the chi-square test, and binomial logistic regression analysis were performed to identify factors influencing sentinel events.Results: Of the 532 incidents, 46 (8.6%) were sentinel events. The results of the binomial logistic regression analysis showed that the odds of sentinel events were 5.43 times higher in patients in their 70s than in those in their 30s. General hospitals had 76% lower odds of serious medical device accidents compared to hospitals.Conclusion: Patient age and hospital type are factors influencing medical device-related sentinel events. To prevent such events, medical institutions should strengthen professional management and monitoring of elderly patient care, and government support for small hospitals should also be considered.