Dependability: a challenge for electrical medical implants

Abstract

Functional Electrical Stimulation (FES) is an attractive solution to restore some lost or failing physiological functions. Obviously, the FES system may be hazardous for patient and the reliability and dependability of the system must be maximal. Unfortunately, the present context, where the associated systems are more and more complex and their development needs very cross-disciplinary experts, is not favorable to safety. Moreover, the direct adaptation of the existing dependability techniques from domains such as space or automotive is not suitable. Firstly, this paper proposes a strategy for risk management at system level for FES medical implant. The idea is to give a uniform framework where all possible hazards are highlighted and associated consequences are minimized. Then, the paper focuses on critical parts of the FES system: analog micro-circuit which generates the electrical signal to electrode. As this micro-circuit is the closest to the human tissue, any failure might involve very critical consequences for the patient. We propose a concurrent top-down and bottom-up approach where the critical elements are highlighted and an extended risk analysis is performed.

Towards a Dependable Cardiovascular Surveillance System

“…The first step on the development of a dependable medical monitoring device is identifying the system's risks of not achieving acceptable levels of dependability. After this, fault detection and fault tolerance/reconfiguration techniques will be used to detect system malfunctions and correct them in order to achieve high levels of dependability [5], [6]. Data fusion techniques can also be utilized to improve the cardiovascular surveillance system in mainly two aspects.…”