Model-Based Risk Analysis for an Open-Source PCA Pump Using AADL Error Modeling

Abstract

Risk management is a key part of the development of medical devices to achieve acceptable product safety and pass regulatory scrutiny. As model-based development (MBD) techniques gain ground in the medical device industry, the medical device industry needs guidelines on the best practices of integrating risk management principles and activities in MBD-driven product development. In this paper, we demonstrate how the SAE standard Architecture, Analysis, and Definition Language (AADL) and its Error Modeling (EM) annex can be applied in the development of an open-source patient-controlled analgesic (PCA) pump to support the risk management tasks of ISO 14971 - the primary risk management standard in the medical device domain. While AADL EM has been applied in other domains, our work provides the first mapping of AADL EM to ISO 14971 concepts. It not only represents one of the largest applications to-date of AADL’s EM framework, but also provides the industry and academia an example with considerable complexity to investigate methodologies and methods of integrating MBD and risk management. This work is part of the Open PCA Pump project, which presents a variety of open source integrated development artifacts for a realistic medical device.