SOLICITATION NOTICE
A -- Autonomous Critical Care System - Full Announcement
- Notice Date
- 4/1/2011
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Navy, Office of Naval Research, ONR, CODE ONR-02, 875 North Randolph St., Suite 1425, Arlington, Virginia, 22203-1995
- ZIP Code
- 22203-1995
- Solicitation Number
- ONRBAA11-012
- Archive Date
- 5/31/2011
- Point of Contact
- Patrick Sisk, Phone: 703-696-6804, Michael I Given, Phone: (703) 696-0455
- E-Mail Address
-
Patrick.Sisk@navy.mil, michael.given@navy.mil
(Patrick.Sisk@navy.mil, michael.given@navy.mil)
- Small Business Set-Aside
- N/A
- Description
- Full Announcement 01 APR 2011 The Office of Naval Research (ONR) is interested in receiving proposals for development of an Autonomous Critical Care System. Background: The ONR Force Health Protection program has been researching use of autonomous (closed-loop-control) systems for fluid resuscitation and mechanical ventilation since 2005 which demonstrated improved medical situational awareness and safety while reducing logistical requirements for fluids and oxygen. As a continuation of these studies ONR approved a Science and Technology (S&T) research program to develop a prototype Autonomous Critical Care System (ACCS). Need Statement: To support naval combat and humanitarian assistance/disaster relief missions there is a need for a modular, automated, critical care system for close management of hemodynamically unstable patients. The system may be employed in both land-based and shipboard medical treatment facilities and during medical evacuation to a sea-base, as a means to increase survivability and improve patient outcomes. Minimally-supervised patient transport may be accomplished by ground vehicle, rotary or fixed wing aircraft, or by high-speed vessel, and the system will need to provide continuous monitoring and medical management of patients to prevent any degradation in clinical status. It is also anticipated that unmanned ground or air vehicles may be used in the future for patient transport and the system will validate effective patient monitoring and control in an unmanned vehicle during transport. Objective: Advances in machine learning and associated development of computer-based automated control algorithms, device integration, and wireless communications enable improved pre-hospital and hospital patient care capabilities. The goal of this program is to develop a prototype system that will provide complete medical management of a critically injured casualty for a period ≥ 6 hrs without human intervention and to demonstrate the ability of the system to correctly diagnose and manage a series of scripted, medically complex, life-threatening clinical events. The prototype system will have both decision-assist and fully-autonomous (i.e. closed-loop-control) capabilities, or mixed modes selected by the caregiver. Decision-assist algorithms provide treatment recommendations based on the real-time assessment of the physiology of the patient which can either be accepted or rejected by the caregiver; closed-loop-control algorithms manage the patient without caregiver input. The development and implementation of closed-loop algorithms must be done in accordance with 21 CFR 820.30 Design Controls. The ACCS can be thought as "system of systems" which contains both hardware and software components and requires near infallibility and redundancy to prevent loss of life. Selection of components must be based on performance, reliability, usability and maintainability. The ACCS should be scalable, i.e. modular in design to allow addition/removal of components to meet mission requirements; components should be plug-and-play to the greatest extent possible. Software will be assessed as to efficiency, integrity, reliability, survivability, usability, correctness, maintainability, verifiability, expandability, flexibility, and interoperability. A spiral development process is desired to incorporate changes resulting from experimentation as well as technology opportunities. Table 1: Key Performance Parameters Key Performance Parameters (KPPs) Development Objectives System Performance: 1. Successful demonstration of ACCS ability to manage a large animal poly-trauma model (hemorrhagic shock, bone fracture, muscle damage and moderate/severe traumatic brain injury) under controlled (laboratory) and operational conditions for a minimum of six (6) hours. As part of the evaluation process the system must be able to demonstrate ability to successfully manage induced clinical events to insure survival of the patient. 2. Demonstrate remote monitoring and control of the ACCS. 3. Demonstrate remote monitoring and control of the ACCS in an unmanned ground or air vehicle using combatant communication network. Table 2: Key System Attributes Attribute Development Objectives Weight: < 30 lbs; The objective is to make the system as small and as light as possible. Size: Must be able to fit in all current naval air platforms (CH46 & CH53, and MV22). Attachment: Integral attachment to NATO litter; allows 80% accessibility to patient. Low Heat Transmission: Can be safely touched with bare skin. Power: The system: (1) must operate from 110/220 VAC, 60 Hz, or 8-48 VDC; (2) will have a rechargeable battery capable of operating for 8 hours; (3) will have a recharge time < 3 hrs; (4) allow renewing or change of power sources without interrupting operations; (5) will display total power received, time to full charge, time to full discharge, useable power life; (6) must have back-up power source capable of 8-hr autonomous operation. Alternate Monitor Display: The system will have redundant monitor capability. System Notification: The system will have manually adjustable audible and visual alarms over an intensity range of 0-100% with 99% effectiveness and accuracy while operating. Patient Data and Documentation: The system will: (1) use industry standard data storage and data transfer technology; (2) capture, store, and display both patient and system information at a minimum of 48 hours; (3) have an open architecture to log and store patient clinical parameters and waveforms at a minimum of 48 hours; (4) provide for data transferable between device and remote medical treatment facility; (5) have simulation and training software to familiarize medical personnel with operation and maintenance of device. Telemedicine and Wireless Capability: The system will: (1) provide for physician monitoring of patient status and system override capability from a remote medical treatment facility; (2) have wireless patient monitoring capability. Central Control Processing Unit: Has interface point and unified control/integrated display. Internet Accessibility: Must be Net Ready as defined in CJCSI 6212.01; 15-Dec-08. Peripheral Hardware Interface: The system will capture, store, and display both patient and system information from attached clinical components with 99% accuracy. Patient Warming: Closed-loop-control maintenance of body temperature +/-1 degree F. Physiological and Hemodynamic Monitoring The system will: (1) monitor, record and display heart rate (derived from ECG, NIBP, or other); (2) have wireless 3-12 lead ECG monitoring capability; (3) have arrhythmia detection and alarm capability; (4) capture and record respiratory rate, pulse-oximetry, and non-invasive cardiac output, total peripheral resistance, stroke volume; (5) have four separate channels for intravascular catheters.; (6) have clinical parameters and waveforms that are parameters and waveforms that are visualized with 99% accuracy during movement; (7) have wireless patient monitoring capability to include SPO2. Fluid and Drug Therapy: The system will: (1) be decision-assist and closed-loop control capable; (2) record (date and time stamp) patient measurements and interventions, and cumulative total fluid received (infused and net volumes); (2) have decision-assist and closed-loop control algorithms control rate and volume of multiple fluids (crystalloids, colloids, blood/blood products); (3) have fluid warming to 40oF capability; (4) be rapid fluid infuser capable (6L/hr) with free-flow protection and vented bubble detection/removal; (5) have industry standard alarms (audio and visual), including low battery alarm; (6) provide a library of medications of commonly used drugs to treat trauma patients (e.g. epinephrine, phenylephrine, dopamine, vasopressin, paralytics, etc), and a system to allow drug calculations. Oxygen Generating: The system will: (1) provide 6L/min of 93% United States Pharmacopeia (USP) oxygen (+/-) 5%; (2) provide inspired oxygen (FiO2) range of 21% to 100%; (3) control low flow oxygen source to maintain stable FiO2. Ventilation: The system will: (1) have decision-assist and closed-loop algorithms for delivery of FiO2 (21-100%) and positive end-expiratory pressure (PEEP) (0-25 +/- 1 cm H2O); (2) have a flow capable ventilator (100L/min at 40 cm H2O); (2) control low flow oxygen source to maintain stable FiO2 +/- 5% and alarm; (3) have pressure- and volume-controlled ventilation modes for pediatric and adults; (4) accept oxygen input pressure of 35-70 psi; (5) display and monitor inspired oxygen concentration (FiO2) and end tidal CO2; (6) provide humidified oxygen (100% saturation); (7) allow administration of aerosolized medications; (8) have programmable standard of care alarms: low pressure, high pressure, apnea, low source gas pressure, power supply low, low minute ventilation, high respiratory rate; Decision-assist algorithms for all alarm conditions; (9) automatically restarts after unexpected loss of power with user approved settings before reinitiating; (10) create exportable records of ventilator performance; (11) displays operational time remaining for battery life; (12) have time stamp, capture and playback capability for waveforms and significant events. Suction: The system will: (1) be capable of suctioning with variable digital control and intermittent and constant suction capable of high/low endotracheal tube, gastic, and chest tube; (2) have controlled suction capability (10-300 mm Hg); (3) have pop-off valves. Analgesia/Anesthesia: System will have (1) standard of care and total intravenous anesthesia (TIVA) capability; BIS monitoring capable. Documentation: Manuals and simulation and training software to familiarize medical personnel with operation and maintenance of system. Environmental: Must meet MIL-STD 810F; MIL-STD 202G for environment exposure. CBRN Filtration: The device will have a filter system for ventilation that is 100% CBRN effective. Airworthiness release (AWR) for rotary and fixed wing evacuation aircraft: Function of Navy Advanced Development Program Offerors are encouraged to submit proposals for the entire system, or for the development of decision-assist and closed-loop algorithm-controlled component devices for: • Mechanical ventilation • Fluid and drug therapy • Anesthesia/analgesia • Patient warming • Suction (endotracheal, gastric and chest tubes) • Oxygen production Offerors are also encouraged to submit proposals for: • Communication/telemedicine capabilities • System integration Validation\integration of decision-assist and closed-loop algorithms for the control of mechanical ventilation, suction, oxygen production, fluid and drug therapy, anesthesia and analgesia, and management of core temperature may be the responsibility of a Prime contractor or of a lead System Integrator; the approach is TBD. Exit Criteria: Successful completion of the tasks as described in Table 1 resulting in the development of the ACCS to Technology Readiness Level (TRL) 6, "System tested with interfaces and support systems in relevant or simulated operational environment. Configuration Management Approach developed". It is anticipated that further development, clinical evaluation, and regulatory approval of the entire system will be supported by the Navy Advanced Medical Development Program through subsequent awards outside of this BAA. As the device must ultimately be approved by the FDA records must be kept in compliance with GLP/GMP guidelines to support an FDA IDE application per regulations under 21 CFR 812 and Pre-Market Approval (PMA) as a Class III medical device under 21 CFR 814.3.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/ONR/ONR/ONRBAA11-012/listing.html)
- Record
- SN02415758-W 20110403/110401235129-6f73d2007ddb3fa4e139daff3a3577d3 (fbodaily.com)
- Source
-
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