Capturing Essential Information to Achieve Safe Interoperability.
Capturing Essential Information to Achieve Safe Interoperability.
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DOI：
10.1213/ane.0000000000001351
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发表时间：
2017-01
影响因子：
5.7
通讯作者：
Goldman JM
中科院分区：
文献类型：
--
作者：
Weininger S;Jaffe MB;Rausch T;Goldman JM
在本文中，我们描述了“临床场景”信息在确保互操作系统安全方面的作用，以及系统提供必要的临床功能以改善临床护理的能力。描述了捕获临床环境中的临床需求、工作流程、危险和设备交互的方法和基本原理。可以从这些信息中得出关键用户（临床医生和临床工程师）的需求和系统要求，从而改善临床医生与医疗设备和信息技术系统开发人员的沟通。该方法旨在通过提供临床定义来支持系统工程过程中的要求，特别是那些专注于标准 ASTM F2761 中描述的集成临床环境开发的要求，从而帮助医疗保健界（包括研究人员、标准开发人员、监管机构和制造商）。我们的重点是使用称为医疗设备接口数据表 (MDIDSa) 的文档工具来识别和记录系统内的相关交互和医疗设备功能，并减轻与工作流程、产品可用性、数据集成以及缺乏有效的医疗设备-健康信息技术系统集成相关的危险情况，以实现安全的互操作性。提供了“患者自控镇痛安全联锁”临床场景的部分分析来说明该方法。收集更好的临床不良事件信息和建议的解决方案可以帮助确定提高当前设备功能和互操作性的机会，并支持学习健康系统以改善医疗保健服务。开发和分析临床场景是创建解决方案以解决棘手的患者安全问题并实现临床创新的第一步。描述了一种基于网络的研究工具，用于实现获取和管理此信息的方法，即临床场景存储库™。
In this article we describe the role of “clinical scenario” information to assure the safety of interoperable systems, as well as the system’s ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets (MDIDSa) and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a “Patient-controlled analgesia safety interlock” are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a Learning Health System to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™, is described.