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首页> 外文期刊>International journal of design engineering >Quantitative reliability assessment based design of a medical fluid management system
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Quantitative reliability assessment based design of a medical fluid management system

机译：基于定量可靠性评估的药液管理系统设计

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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.
机译：医疗设备制造商通过考虑确定性的“安全因素”来建立支持系统设计的限制，从而采用传统的设备设计方法。然而，这种方法对于复杂且不确定的工程系统可能效率不高，并且随着医疗系统复杂性的增加，对用于量化设计不确定性的实用工具的需求也随之增加。随机可靠性工程评估在医疗设备行业中还没有很好地建立起来，制造商倾向于采用包括各种定性可靠性方法的可靠性程序。本文提出了一种基于概率的定量随机方法，该方法使用蒙特卡罗模拟（MCS）和一阶可靠性方法（FORM）对内窥镜设置的医用管道流量系统进行不确定性量化分析。通过将结果与成本和基于风险的约束进行镜像，并从系统可靠性，用户滥用风险和设备故障成本方面进行解释，本文的结论强调了对医疗设备制造商采用随机方法的好处。

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