An Integrated Development and Certification Environment for a Medical Device Coordination Framework

医疗器械在历史上一直是整体单元-作为独立实体由监管机构开发、验证和批准。然而，现代医疗设备越来越多地结合连接机制，这些连接机制提供了通过网络/中间件技术将设备集成到协作设备的更大系统中的潜力。这个NSF-FDA驻校学者研究项目支持这个由NSF支持的学术研究团队与FDA器械和放射卫生中心（CDRH）以及医学和技术整合中心的一个团队和宾夕法尼亚大学的一个团队就这个问题进行互动。 我们的目标是超越早期的工业医疗设备集成工作，专注于将设备数据流传输到电子健康记录中，并将来自多个设备的信息集成到单个可定制的显示器中。 该项目的目标是支持协调协作设备组的行动的框架，以潜在地实现“闭环”场景。 这项工作预计将通过控制网络设备来自动化临床工作流程，因为它们执行协作任务。 该项目建立在一个开源的医疗器械协调框架（MDCF）上，该框架是在先前的NSF资助下开发的。MDCF包括（a）用于集成医疗设备和EHR的中间件，以及（B）基于模型的开发环境，该开发环境可用于快速实现医疗设备协调应用，从而实现上述医疗设备的“系统的系统”范例。 MDCF已经支持医疗设备、显示器、协调逻辑和临床决策支持模块的组件接口的快速开发。这项研究扩展了MDCF的快速发展的需求文件，危害分析，并与质量保证技术，包括测试，静态分析和正式验证的协调应用程序及其组件的正确性索赔。 FDA目前根据其关键性对传统医疗器械进行分类，但对于器械协调应用程序不存在此类计划。本研究正在为器械协调应用开发关键性分类方案，该方案将为监管监督提供结构。 这项研究还提供了基础设施，为快速发展的协调应用程序的保证情况下，使用安全的情况下，一种方法，使用半正式符号的结构化参数文件和提供证据，安全索赔的系统得到满足。

Medical devices historically have been monolithic units -- developed, validated, and approved by regulatory authorities as stand-alone entities. Yet modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to integrate devices via network/middleware technology into larger systems of cooperating devices. This NSF-FDA Scholar In Residence research project supports interaction by this NSF-supported academic research team with the FDA Center for Device and Radiological Health (CDRH), as well as with a team from the Center for Integration of Medicine and Technology and a team from the University of Pennsylvania on this problem. The goal is to move beyond early industrial medical device integration efforts that focus on streaming device data into electronic health records and integrating information from multiple devices into single customizable displays. The objective of the project is to support frameworks that coordinate the actions of groups of cooperating devices to potentially realize "closed loop" scenarios. This work is expected to automate clinical workflows by controlling networked devices as they perform cooperative tasks. The project builds on an open source Medical Device Coordination Framework (MDCF) that has been developed under prior NSF funding. The MDCF includes (a) middleware for integrating medical devices and EHRs and (b) a model-based development environment that could be used to quickly implement medical device coordination applications enabling a "systems of systems" paradigm for medical devices as described above. The MDCF already includes support for rapid development of component interfaces for medical devices, displays, coordination logic, and clinical decision support modules. This study extends the MDCF for rapid development of requirements documents, hazard analysis, and correctness claims associated with quality assurance techniques including testing, static analysis, and formal verification of coordination applications and their components. The FDA currently classifies conventional medical devices according to their criticality, but no such scheme exists for device coordination applications. This study is developing a criticality classification scheme for device coordination applications that will provide a structure for regulatory oversight. The study also is providing infrastructure for rapid development of coordination application assurance cases using safety cases an approach that uses semi-formal notations for structured arguments to document and provide evidence that safety claims for a system are satisfied.