Assurance Cases for a Physiologically Closed-Loop PCA Systems

生理闭环 PCA 系统的保证案例

• 批准号: 1042829
• 负责人: Insup Lee
• 金额: $ 2.5万
• 依托单位: University of Pennsylvania
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-11-01 至 2013-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1042829&HistoricalAwards=false
• 关键词: Assurance; Cases; Physiologically; Closed; Loop; Assurance; Cases; Physiologically; Closed; Loop

Since software is easier to configure, modify and re-use than hardware, an increasingly large portion of a medical device?s functionality is now being implemented in code. This presents considerable engineering challenges for both device regulators and manufacturers in terms of ensuring the safety and effectiveness of the deployed software. This NSF-FDA Scholar in Residence project focuses on the use of generic software architecture specifications for medical devices as a path to reducing the complexity of engineering medical device software. For manufacturers, generic device specifications can serve as a base artifact from which concrete implementations may be constructed. For regulators, they represent an artifact that can be modeled and used in evaluating implementations for adherence to a base set of safety requirements. The primary goals of this project are to explore a generic infusion pump architecture that can be extended to different infusion pump classes while preserving the requisite safety properties in a trustable, verifiable manner. The project explores challenges for developing usable generic device software architecture specifications and for applying them: producing concrete device instances, constructing extended subclasses from the generic architecture while verifying that properties are preserved, and supporting regulators and manufacturers as they evaluate device software conformance to safety architectures. The research employs model-checking, assertion-based verification, static analysis and reverse engineering to support assurance of safety-critical devices such as the Patient-Controlled Analgesia (PCA) infusion pump. The aim of the research is to provide an informative pilot study towards adoption of such techniques in device manufacturing workflows and regulatory regimes. One of the driving goals of this project is to create techniques and approaches that will benefit patients (by increasing device safety), device manufacturers (by helping them cut development costs) and regulators (by enabling them to automate and formalize their regulatory activities).

由于软件比硬件更易于配置，修改和重复使用，因此现在在代码中实现了医疗设备的功能越来越大。这在确保已部署软件的安全性和有效性方面为设备调节器和制造商带来了巨大的工程挑战。 这个NSF-FDA居住项目的NSF-FDA学者着重于将通用软件体系结构规范用于医疗设备，以减少工程医疗设备软件的复杂性。对于制造商而言，通用设备规格可以用作可以从中构建具体实现的基础工件。对于监管机构，它们代表了一个可以建模和用于评估实现的工件，以遵守一系列安全要求。 该项目的主要目标是探索一种通用的输液泵体系结构，该体系结构可以扩展到不同的输液泵类，同时以可信赖的可靠性方式保留必要的安全性。该项目探讨了开发可用的通用设备软件体系结构规范的挑战并应用它们：生产具体设备实例，从通用体系结构中构建扩展的子类，同时验证保留属性的属性，并在对安全体系中评估设备软件的构造时，并支持监管机构和制造商。 该研究采用模型检查，基于断言的验证，静态分析和反向工程来支持对安全关键设备（例如患者控制的镇痛）（PCA）输液泵的保证。 该研究的目的是提供一项丰富的试点研究，以在设备制造工作流和监管制度中采用此类技术。 该项目的驱动目标之一是创建将使患者（通过提高设备安全），设备制造商（通过帮助他们削减开发成本）和监管机构（通过使他们自动化并正式化监管活动）受益的技术和方法。