Title: Quantitative reliability assessment based design of a medical fluid management system

Authors: Andrè Lupi; Athanasios Kolios; Konstantinos Salonitis

Addresses: Olympus KeyMed, KeyMed House, Stock Road, Southend-on-Sea, Essex, SS2 5QH, UK ' Cranfield Energy, Cranfield University, Cranfield Bedfordshire MK43 0AL, UK ' Sustainable Manufacturing Systems Centre, Cranfield University, Cranfield Bedfordshire MK43 0AL, UK

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.

Keywords: Monte Carlo simulation; MCS; first order reliability method; FORM; medical device reliability; probabilistic assessment; design factor of safety; medical device design; medical devices; fluid management systems; uncertainty; design engineering; medical pipe flow; endoscopy; user misuse; device failure costs; stochastic methods.

DOI: 10.1504/IJDE.2015.076375

International Journal of Design Engineering, 2015 Vol.6 No.2, pp.91 - 115

Received: 13 Sep 2014
Accepted: 24 Sep 2015
Published online: 05 May 2016 *

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