Incidence and root cause analysis of near-miss events in medical device use errors in intensive care units using Ishikawa diagram

Abstract

Aim: This study aimed to investigate the incidence of near-miss events related to medical device use errors (MUEs) in intensive care units (ICUs) and to identify their root causes using the Ishikawa diagram. Methods: This observational study was conducted in a referral hospital ICU in South Korea between August and September 2023, involving 60 nurses (29 MICU, 31 SICU) who completed anonymized questionnaires on near-miss events related to five commonly used medical devices. Root causes were analyzed with a modified Ishikawa diagram. Data were processed using SPSS software. Independent t-tests, ANOVA, and Pearson correlation were used for continuous variables, while chi-square and Fisher's exact tests were applied to categorical data. One-way ANOVA identified major contributing factors. Results: Each participant experienced an average of 2.11 ± 12.53 near-miss events per device per year, with the highest incidence in IV line sets. A positive correlation was found between near-miss frequency and years of work experience. Root cause analysis (RCA) showed that the most common contributing factors were work environment factors, especially high patient load. The main contributing factors included chronic fatigue (personal factors), frequent device malfunctions (medical device usability factors), and insufficient education programs (unit communication and culture/education factors). Conclusions: The study highlights the importance of improving working conditions, updating outdated equipment, and strengthening educational programs to reduce MUEs and improve patient safety in ICUs. © 2025 Elsevier B.V., All rights reserved.