Toward patient safety in closed-loop medical device systems

TLDR

Few medical systems support closed‑loop control of interconnected devices, and regulatory approval mechanisms are lacking. The study presents a model‑driven design and validation of closed‑loop medical device systems aimed at reducing human error and improving patient safety in a clinical scenario. The authors implemented a clinical scenario, evaluated safety with a simple literature‑based controller, and then introduced a more complex controller that maintains safety under failure conditions. They found that patient safety is not guaranteed under certain failures, but the more complex controller ensures safety even when failures occur.

Abstract

A model-driven design and validation of closed-loop medical device systems is presented. Currently, few if any medical systems on the market support closed-loop control of interconnected medical devices, and mechanisms for regulatory approval of such systems are lacking. We present a system implementing a clinical scenario where closed-loop control may reduce the possibility of human error and improve safety of the patient. The safety of the system is studied with a simple controller proposed in the literature. We demonstrate that, under certain failure conditions, safety of the patient is not guaranteed. Finally, a more complex controller is described and ensures safety even when failures are possible. This investigation is an early attempt to introduce automatic control in clinical scenarios and to delineate a methodology to validate such patient-in-the-loop systems for safe and correct operation.