Assurance Cases for a Physiologically Closed-Loop PCA Systems

由于软件比硬件更容易配置、修改和重复使用，医疗设备中越来越大的一部分-S功能现在正以代码实现。这对设备监管机构和制造商在确保所部署软件的安全性和有效性方面都提出了相当大的工程挑战。这个NSF-FDA学者驻留项目专注于使用医疗器械的通用软件架构规范，作为降低工程医疗器械软件复杂性的一种途径。对于制造商来说，通用设备规范可以作为构建具体实现的基础构件。对于监管者来说，它们代表了一个构件，可以对实现进行建模并用于评估实现是否符合基本的安全要求集。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别，同时以可信、可验证的方式保持必要的安全属性。该项目探讨了开发可用的通用设备软件体系结构规范和应用这些规范所面临的挑战：生成具体的设备实例，从通用体系结构构造扩展的子类，同时验证属性是否被保留，以及支持监管机构和制造商评估设备软件与安全体系结构的一致性。这项研究使用模型检查、基于断言的验证、静态分析和逆向工程来支持安全关键设备的保证，例如患者自控止痛泵(PCA)。这项研究的目的是为在设备制造工作流程和监管制度中采用这种技术提供一个信息丰富的试点研究。该项目的主要目标之一是创建使患者(通过提高设备安全性)、设备制造商(通过帮助他们降低开发成本)和监管机构(通过使他们能够自动化和正规化其监管活动)受益的技术和方法。

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).