Analysis of Medical Device–related Incident and Accident Cases by Clinical Engineering Technologist Using Open Data

In this study, we analyzed numerous incident and accident reports with medical devices involving clinical engineering technologists. The reports were collected from the Project to Collect Medical Near-Miss/Adverse Event Information conducted by the Japan Council for Quality Health Care. We analyzed 180 accidents and 1,321 incidents reported between 2010 and 2024 using text mining. Many common words, such as check, circuit, ventilator, and connection, appeared in the incident and accident case reports. The results of the cross-tabulation analysis revealed that the factors that led to cases were not related to the case outcomes. However, the frequency of cases in which intensive medical treatment was required owing to medical accidents involving circulatory assist devices and cardiac pacemakers was higher than for other medical devices. In addition, in incident cases, circulatory system medical devices were more likely to pose a higher risk of death or residual damage than other devices. Moreover, certain trends were observed in the situations and times when accidents or incidents occurred, depending on the type of medical device.