Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database.

Objective: This study aimed to assess the factors associated with medical device incidents.

Methods: In this mixed-methods study, we used incident reporting data from the Japan Council for Quality Health Care. Of the 232 medical device-related reports that were downloaded, 34 (14.7%) were ventilator-associated incidents. Data related to patients, situations, and incidents were collected and coded.

Results: The frequencies of ventilator-associated accidents were 20 (58.8%) during the daytime and 14 (41.2%) during the night/early morning. Ventilator-associated accidents occurred more frequently in the hospital room (n = 22 [64.7%]) than in the intensive care unit (n = 4 [11.8%]). Problems with ventilators occurred in only 4 cases (11.8%); in most cases, medical professionals experienced difficulty with the use or management of ventilators (n = 30 [88.2%]), and 50% of them were due to misuse/misapplication of ventilators (n = 17 [50.0%]). Ventilator-associated accidents were caused by an entanglement of complex factors-hardware, software, environment, liveware, and liveware-liveware interaction. Communication and alarm-related errors were reported to be related, as were intuitiveness or complicated specifications of the device.

Conclusions: Our study revealed that ventilator-associated accidents were caused by an entanglement of complex factors and were related to inadequate communication among caregivers and families. Moreover, alarms were overlooked owing to inattentiveness. Mistakes were generally caused by a lack of experience, insufficient training, or outright negligence. To reduce the occurrence of ventilator-associated accidents, hospital administrators should develop protocols for employment of new devices. Medical devices should be developed from the perspective of human engineering, which could be one of the systems approaches.