Description:
OBJECTIVE: Develop a stand-alone device for the remote triage of wounded soldiers on the battlefield to rapidly assess vital signs from a distance. DESCRIPTION: When a soldier is injured on the battlefield, medical personnel, as well as non-medical first responders, must physically reach the soldier to determine whether or not the soldier needs immediate medical attention (triage). Triage sorts casualties based on the severity of their injuries with the aim to treat, monitor, and evacuate casualties to the appropriate level of care. In an effort to reduce the need to put first responders in harm"s way, a device is needed in order to accurately assess the vital signs of injured soldiers from a distance. Per the Theater Combat Casualty Care (TC3) Initial Capabilities Document (ICD), a level one (1) priority is the ability to locate and evaluate casualties. First response capability requires improved material solutions to recognize, locate, assess, treat, monitor, and evacuate casualties without degradation to their condition. A remote triage solution provides rapid identification of casualties and enhances the skill level of all without placing them in further danger. This device would also provide medical personnel, as well as non-medical first responders, the ability to operate safely in a chemical, biological, radiological, nuclear (CBRN) environment. Remote triage, integrated with telemedicine capabilities and the Theater Medical Information Program (TMIP) will allow increased capabilities for first responders by providing access to clinicians at higher levels of health care. PHASE I: Conceptualize and design an innovative materiel solution for a remote triage device. 1) Develop an initial concept design and model key elements of the remote triage device for all the following requirements: a. Detect and assess heart rate, blood pressure, and oxygen (O2) saturation with an minimum accuracy of 95%. b. Assess vital signs through obstacles and debris made of materials such as wood, plaster, rock, metal, and concrete. c. Assess vital signs at a minimum distance of 15 meters (Threshold [T]) with an unobstructed view; 50 meters (Objective [O]). d. Must be stand-alone with no remote sensors required. e. Must weigh no more than 10 pounds (T); 5 pounds (O). f. Must be no larger than 2 cubic feet (ft3); 1 ft3 (O). g. Continuously operate on standard disposable batteries for 6 hours (T); 12 hours (O). 2) Identify regulatory requirements and develop a plan detailing how they will be achieved. The required Phase I deliverables are a technical feasibility report, the initial concept design, models of the key elements, and the regulatory requirements report and action plan. PHASE II: Use the results from Phase I to develop, test, and demonstrate working prototypes based on the initial concept design adhering to any regulatory action plan developed. In addition, monitor market research, literature updates, and military doctrine to conceptualize additional features and enhancements, such as the following: Measuring body temperature Circulating blood volume status Algorithms to assess status and determine severity Open architecture and integration into telemedicine and information networks Security, privacy, and confidentiality of patient data on the device and during transmission. The required Phase II deliverables are the following: 1) Monthly progress report(s) 2) Annual report(s) 3) At least three working prototypes 4) Feasibility report regarding the additional Phase II considerations 5) Provide a detailed plan for life-cycle analysis and validation of the proposed design 6) Commercialization transition plan. PHASE III: Focus on commercialization and continued development into a production ready device that meets all regulatory and user requirements. Explore tailoring to user needs (fit and form), additional vital signs, open architecture and system integration. Address and assess additional requirements, such as MIL-STD-810 testing. This device has potential commercial applications in first responder, emergency assistance, or mass casualty scenarios in which finding wounded or trapped persons is essential and must be rapid. Organizations such as the Red Cross and the Federal Emergency Management Agency (FEMA), as well as emergency medical technicians and firefighters could utilize this technology for search and rescue of wounded in rubble, rescue victim location, and disaster recovery. Additional use could be realized for medical monitoring in fixed facilities at all levels of military and civilian care. Tactical scenarios, such as through-wall identification of targets and remote surveillance, are practical using this technology, benefitting special operations, federal investigators, and police SWAT teams. REFERENCES: 1. Poropatich, COL Ronald, USAMRMC,"TATRC"s Strategy for the Research and Development of Mobile Health Applications,"Presented to the FCC, 12 July 2010. http://www.tatrc.org/conferences/ata_2010/ppt/13_Poropatich_ATA2010_May.pdf 2. Manemeit, Carl and G.R. Gilbert,"Joint Medical Distance Support and Evacuation JCTD, Joint Combat Casualty Care System Concept of Employment,"NATO HFM-182-33 paper, 21 April 2010. http://ftp.rta.nato.int/public/PubFullText/RTO/MP/RTO-MP-HFM-182/MP-HFM-182-33.doc 3. S. M. Wendelken, S. P. McGrath and G. T. Blike,"A Medical Assessment Algorithm for Automated Remote Triage."In Proceedings of the 25th Annual Engineering in Medicine and Biology Conference, 2003. http://www.ists.dartmouth.edu/library/83.pdf 4. Initial Capabilities Document for Theater Combat Casualty Care (TC3), October 2007. 5. Ryan KL, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Cain J, Convertino VA."Advanced technology development for remote triage applications in bleeding combat casualties."US Army Med Dep J. 2011 Apr-Jun: 61-72.
