Safety analysis of adverse events associated with high-flow nasal cannula therapy: A retrospective study using Japan’s national adverse event database

Objective This study aimed to extract incident and accident reports associated with high-flow nasal cannula (HFNC) therapy from the publicly available database maintained by the Japan Council for Quality Health Care (JCQHC) and to identify contributing factors using the P-mSHEL model (Patient–management–Software–Hardware–Environment–Liveware), with the goal of providing insights for improving HFNC safety. Methods Among 94,069 incident reports (defined as cases without patient harm) and 56,783 accident reports (cases with patient harm) submitted between 2010 and 2023, a total of 170 HFNC-related cases (131 incidents and 39 accidents) were identified. Quantitative variables included the time of occurrence, patient demographics, and involvement of healthcare professionals. Qualitative data were classified into six categories (P, m, S, H, E, L) using the P-mSHEL model. For accident cases, the presence or absence of sequelae was analyzed using logistic regression. Results In accident cases, the Patient (P) factor (odds ratio = 2.65, p = 0.006) and the Management (m) factor (odds ratio = 2.46, p = 0.033) were significantly associated with the occurrence of sequelae. In incident cases, the Liveware (L) factor (i.e., human error) was involved in 80.2% of reports, and the Hardware (H) factor (i.e., medical devices) in 52.7%, highlighting the critical roles of human and device-related factors. Conclusion To ensure the safe use of HFNC, it is essential to implement risk mitigation strategies targeting the Patient and Management factors, such as comprehensive patient screening and strengthened organizational systems. Furthermore, given the high involvement of the Liveware and Hardware factors, structured educational programs and practical interventions for medical device operation are warranted.