Improving Patient Safety Related to Medication Infusion Pump Technology using Sys

摘要 临床医生、工程师和医疗保健提供者指出，药物输液泵是最有问题的 当今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)的说法， 这些设备的问题源于糟糕的软件设计/实现和人为因素 除了其他方面的考虑。从2005到2009年，FDA收到了大约56,000份关于 与使用输液泵有关的不良事件，包括许多伤亡。在此期间 在此期间，各公司进行了87次输液泵召回，以解决已确定的安全问题。 根据设备错误报告，目前输液泵的一个主要缺点是人机交互能力差 界面。临床医生经常发现他们自己的工作流程适应输液泵的设计，因为 而不是让机器根据临床医生的需求/工作流程进行设计。这在很大程度上是由于有限的预 输液泵设计中的产品可用性测试和人/系统因素工程。在……里面 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 医学(JHM)正在合作，将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液泵的安全性的解决方案。 我们的具体目标是：(1)确定临床医生使用药物输液泵的要求和 开发有效性测量(MOE)和性能测量(MOP)，(2)开发快速原型 测试模拟输液泵的安全性/可用性和开发药物输液的环境 基于临床医生要求的泵原型，使用系统工程最佳实践，以及 (3)采用高保真模拟技术，测量输液泵的安全性/可用性。我们的方法 和方法遵循系统工程的最佳实践来实现这些目标，目标是 产生性能驱动的要求，以提高医疗器械的安全性。这一方法将迅速产生 原型测试工具(以灵活、可工作的泵模型形式的硬件和软件)，可重新- 供任何寻求改进泵设计的组织使用。

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.