Quantitative reliability assessment based design of a medical fluid management system

Abstract

Medical device manufacturers adopt a traditional approach to device design by considering a deterministic 'factor of safety' to establish limits to support system design. However, this method can be inefficient for complex and uncertain engineering systems and as complexity of medical systems increases, the demand for pragmatic tools to quantify design uncertainty also increases. Stochastic reliability engineering assessment is not very well established in the medical device industry and manufacturers tend to employ reliability programs comprising various qualitative reliability methods. This paper presents a probabilistic-based quantitative stochastic method using Monte Carlo simulation (MCS) and the first order reliability method (FORM) to conduct an uncertainty quantification analysis of a medical pipe flow system for an endoscopic setup. By mirroring the results against cost and risk-based constraints and interpreting them in terms of system reliability, risk of user misuse and cost of device failure, the conclusions to this paper emphasise the benefits of employing stochastic methods to medical device manufacturers.