Improving Patient Safety Related to Medication Infusion Pump Technology using Sys

描述(由申请人提供)：临床医生、工程师和医疗保健提供者指出，药物输注泵是当今临床上使用的最有问题的医疗设备之一。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/实施和人为因素考虑等。从2005年到2009年，FDA收到了大约56,000份与使用输液泵有关的不良事件报告，包括许多伤亡。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。(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。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，而不是让机器设计成符合临床医生的需求/工作流程。这在很大程度上是由于输液泵设计中有限的生产前可用性测试和人/系统因素工程。针对这一问题，约翰霍普金斯大学应用物理实验室(JHU/APL)和约翰霍普金斯医学院(JHM)正在合作，利用模拟环境作为论坛，探索创新的技术解决方案，以提高临床环境中使用的药物输注泵的安全性。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，并制定有效性(MOE)和性能(MOP)措施；(2)开发快速原型环境，以测试模拟输液泵的安全性/可用性，并根据临床医生的要求，使用系统工程最佳实践开发药物输液泵原型；(3)使用高保真模拟，测量输液泵的安全性/可用性概况。我们的方法和方法遵循系统工程的最佳实践来实现这些目标，目的是产生性能驱动的要求，以提高医疗器械的安全性。这种方法将产生快速原型测试工具(以灵活、可工作的泵模型的形式存在的硬件和软件)，可供任何寻求改进泵设计的组织重复使用。 公共卫生相关性：为了提高药物输液泵的安全性，我们建议在医学模拟中心对原型泵设计进行基于软件的模拟的安全性和可用性测试。我们建议遵循系统工程的最佳实践，以引起临床医生的要求，以了解当今泵设计的可用性和安全性问题，并在模拟泵中设计和实施增强功能，以应对这些可用性和安全性挑战。在医学模拟中心的受控条件下进行测试，使我们能够探索在真实世界环境中无法实现的一系列模拟场景的安全性和可用性。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: To improve the safety of medication infusion pumps, we propose conducting safety and usability testing of software-based simulations of prototype pump designs in a medical simulation center. We propose following systems engineering best practices to elicit requirements from clinicians to understand usability and safety issues with today's pump designs and to design and to implement enhancements in simulated pumps to address these usability and safety challenges. Conducting testing under controlled conditions in a medical simulation center allows us to explore safety and usability over a range of simulated scenarios not possible to achieve in a real world setting.