FDA SIR: Compositional Approaches to Safety and Risk Management for Medical Application Platforms

FDA SIR：医疗应用平台安全和风险管理的组合方法

• 批准号: 1446544
• 负责人: John Hatcliff
• 金额: $ 8万
• 依托单位: Kansas State University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2016-02-29
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1446544&HistoricalAwards=false
• 关键词: FDA; SIR; Compositional; Approaches; Safety

Modern medical devices increasingly incorporate connectivity mechanisms that offer the potentialto integrate devices via network/middleware technology into larger systems of cooperatingdevices. Initial integration efforts in the industry are focused on streaming device datainto electronic health records and integrating information from multiple devices into single customizable displays. This proposal provides a research foundation for engineering and verificationof these safety critical systems through creating an open source Medical Device Coordination Framework (MDCF) which includes: 1)middleware for integrating medical devices and electronic health records, and 2) a model-based development environment that implements medical device coordinationapplications (apps for short), enabling a systems of systems paradigm for medical devices. The project has substantial broader impact via tools and techniques for verifying the integration of medical systems that are compatible with the Integrated Clinical Environment standard. In addition, the proposer includes extensive interaction with FDA specialists who are looking to transition these methods into their validation and verification processes for their regulatory mission.

现代医疗设备越来越多地采用连接机制，提供了通过网络/中间件技术将设备集成到更大的合作设备系统中的潜力。行业中最初的集成工作集中在将设备数据流式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。本提案通过创建开源医疗设备协调框架（MDCF）为这些安全关键系统的工程和验证提供了研究基础，该框架包括：1)集成医疗设备和电子健康记录的中间件，以及2)实现医疗设备协调应用程序（简称应用程序）的基于模型的开发环境，使医疗设备的系统范例成为系统的系统。通过验证与综合临床环境标准兼容的医疗系统集成的工具和技术，该项目具有实质性的广泛影响。此外，申请人还包括与FDA专家的广泛互动，这些专家正在寻求将这些方法转化为其监管任务的验证和验证流程。