Lansdowne Krystal, Scully Christopher G, Galeotti Loriano, Schwartz Suzanne, Marcozzi David, Strauss David G
1Center for Devices and Radiological Health,US Food and Drug Administration,Silver Spring,Maryland,USA.
2Office of the Assistant Secretary for Preparedness and Response,US Department of Health and Human Services,Washington DC,USA.
Prehosp Disaster Med. 2015 Jun;30(3):320-3. doi: 10.1017/S1049023X15004641. Epub 2015 Apr 14.
In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.
2010年,美国食品药品监督管理局(美国马里兰州银泉)发起了医疗应对措施倡议,其使命是研发和推广保护美国免受已确定的、高优先级化学、生物、放射或核(CBRN)威胁以及新发传染病侵害所需的医疗应对措施。本综述的目的是促进医疗器械监管科学研究,并分析这些器械如何在不同的CBRN场景中应用。CBRN场景中的检伤分类给急救人员带来了独特挑战,因为CBRN制剂的影响以及每个检伤分类阶段伤亡人员的临床表现可能各不相同。CBRN事件的独特性可能导致标准的患者监测医疗器械和传统的检伤分类算法失效。尽管存在挑战,但CBRN检伤分类技术最近取得了进展,包括:新技术;用于CBRN灾难的移动医疗应用程序(“医疗应用”);电子检伤标签,如eTriage;诊断现场设备,如联合生物制剂识别系统;以及决策支持系统,如化学危害应急医疗管理智能综合征工具(CHEMM-IST)。进一步的研究和医疗器械验证有助于推动CBRN事件的院前检伤分类技术发展。