A consensus model-based risk matrix for human error factors risk analysis in medical devices by considering risk acceptability

Medical devices related event caused by potential human error factors has been one of the leading life -threatening factors. These factors may emerge in multi-hierarchy because of the multi-dimensional organiza-tional structure in the healthcare system. The Human Factor Analysis and Classification System (HFACS), a systematic human error analysis tool, can be integrated with the risk matrix to identify human error factors and prioritize risk in medical devices. Meanwhile, integrating the consensus model into the risk matrix can yield highly recognized risk analysis results. Nevertheless, most consensus models did not consider the heterogenous risk acceptability of experts. Therefore, this paper first proposed a consensus model-based risk matrix to address the HFACS-based human error factor risk analysis problem considering the experts' risk acceptability. In the proposed method, a novel feedback mechanism considering risk acceptability is constructed to guide experts to modify their risk evaluation information and reach a consensus, where experts' risk acceptability model is established to reflect their willingness to adjust risk evaluation information. Especially, a novel consensus measurement is constructed based on the risk rating results yielded by the risk matrix. Finally, a case of risk analysis of human error factors of ventilators is studied to validate the proposed method.

Automated summary

In this study, a consensus model-based risk matrix method is proposed to address the risk analysis of human error factors in medical devices, considering experts' risk acceptability. The Human Factor Analysis and Classification System (HFACS) is integrated with the risk matrix to identify and prioritize human error factors. A novel feedback mechanism and consensus measurement are constructed to guide experts and reach a consensus on risk evaluation information.