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Improving Patient Safety Related to Medication Infusion Pump Technology using Sys

使用 Sys 提高与药物输注泵技术相关的患者安全

基本信息

批准号：
8461989
负责人：
Alan D Ravitz
金额：
$ 34.95万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-05-01 至 2014-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8461989
关键词：
Improving Patient Safety Related Medication

项目摘要

Abstract Clinicians, engineers, and medical care providers cite medication infusion pumps among the most problematic medical devices used today in the clinical setting. According to the US Food and Drug Administration (FDA), the problems with these devices stem from poor software design/implementation and human factor considerations, among others. "From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. During this time period, 87 infusion pump recalls were conducted by firms to address identified safety concerns."(1) A key shortcoming of current infusion pumps, based upon device error reports, is the poor human-machine interface. Clinicians often find themselves adapting their workflow to the designs of the infusion pump, as opposed to having the machines designed to clinician needs/workflow. This is largely due to the limited pre- production usability testing and human/systems factors engineering in the design of infusion pumps. In response to this, The Johns Hopkins University Applied Physics Laboratory (JHU/APL) and the Johns Hopkins Medicine (JHM) are collaborating to use simulation environments as a forum to explore innovative technical solutions to improve the safety associated with medication infusion pumps used in clinical settings. Our specific aims are to: (1) Define clinician requirements in use of medication infusion pumps and develop measures of effectiveness (MOE) and performance (MOP), (2) Develop a rapid prototype environment to test the safety/usability of simulated infusion pumps and develop medication infusion pump prototypes based upon clinician requirements, using systems engineering best practices, and (3) Measure the safety/usability profile of infusion pumps, using high-fidelity simulation. Our method and approach follows systems engineering best practices to accomplish these aims with an objective of producing performance-driven requirements for improved medical device safety. This approach will yield rapid prototyping test tools (hardware and software in the form of flexible, working pump mockups) that may be re- used by any organization seeking to improve pump design.

抽象的临床医生、工程师和医疗保健提供者将药物输液泵列为最有问题的问题之一今天在临床环境中使用的医疗设备。根据美国食品和药物管理局（FDA）的数据，这些设备的问题源于糟糕的软件设计/实施和人为因素考虑因素等。 “从 2005 年到 2009 年，FDA 收到了大约 56,000 份关于与使用输液泵相关的不良事件，包括许多伤害和死亡。在此期间在此期间，公司进行了 87 次输液泵召回，以解决已发现的安全问题。”(1) 根据设备错误报告，当前输液泵的一个主要缺点是人机界面不佳界面。临床医生经常发现自己需要调整工作流程以适应输液泵的设计，例如反对根据临床医生的需求/工作流程设计机器。这主要是由于前期准备有限输液泵设计中的生产可用性测试和人体/系统因素工程。在对此，约翰·霍普金斯大学应用物理实验室 (JHU/APL) 和约翰·霍普金斯大学 Medicine (JHM) 正在合作使用模拟环境作为探索创新技术的论坛提高临床环境中使用的药物输注泵的安全性的解决方案。我们的具体目标是： (1) 明确临床医生使用药物输液泵的要求和制定有效性 (MOE) 和绩效 (MOP) 衡量标准，(2) 开发快速原型测试模拟输液泵的安全性/可用性并开发药物输液的环境根据临床医生的要求，使用系统工程最佳实践制作泵原型，以及 (3) 使用高保真模拟测量输液泵的安全性/可用性概况。我们的方法方法遵循系统工程最佳实践来实现这些目标，其目标是制定性能驱动的要求以提高医疗器械的安全性。这种方法将快速产生原型测试工具（灵活的工作泵模型形式的硬件和软件）可以重新设计任何寻求改进泵设计的组织都可以使用。