Contributing factors of sentinel events involving medical devices: A cross-sectional retrospective human factors analysis

Abstract

Background and objective

Although most medical device applications in hospitals are safe and effective, in a small number of cases devices are involved in patient safety events causing serious unintended patient harm. These so-called sentinel events are thoroughly investigated by hospitals, with detailed event descriptions filed in reports. Studying these reports may help fill the knowledge gap on the latent contributing factors of sentinel events involving medical devices. This study aims to identify the contributing factors of sentinel events involving medical devices and how these factors lead to unintended patient harm.

Design

A cross-sectional retrospective analysis of 20 sentinel event reports involving medical devices from Dutch general hospitals, using a human factors approach and specific classification system for medical device related events.

Results

A total of 105 contributing factors were identified. For most events, factors relating to the operator (e.g., flaws in setting up and checking devices before use), device (e.g., design issues), infrastructure (e.g., poor environmental ergonomics) and patient (e.g., complicating anatomy) mutually contributed and interacted. Jointly these factors triggered events causing unintended patient harm.

Conclusions

In-depth analysis of reports of sentinel events using a human factors approach, showed the underlying patterns of interacting contributing factors leading to unintended patient harm. Sentinel events involving medical devices are triggered by an interplay of factors related to the operator, device, infrastructure, and patient. To prevent future patient harm, an integral approach addressing all these elements is needed.

Public Interest Summary

Medical devices can be involved in events leading to unintended patient harm in hospitals. We know little about the underlying factors contributing to such events. Therefore, 20 reports of events involving a medical device that led to serious patient harm were analysed in depth. In most events, the patient harm was triggered by factors relating to the operator of the device, the device itself, the organisation and environment in which the device was applied, and the patient to whom the device was applied. Jointly, these factors prompted the events and led to patient harm. The insights from this study can be used to further improve the safe application of medical devices in hospitals.