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Expeditionary Medical Refrigeration Unit

Description:

 
 

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: MARCORSYSCOM, Program Manager Combat Support Systems, Battalion Aid Station (BAS) – AMAL 635

OBJECTIVE: The objective is to develop an innovative, energy efficient, small human transportable field refrigeration unit for field medical operations. The unit will be used to keep temperature sensitive human blood products, vaccines, and reagents within an optimum temperature range to ensure long term viability.

DESCRIPTION: Navy Medical Corpsmen, Nurses, and Doctors make frequent use of human blood products for resuscitative medical interventions, administer vaccines to Marines or civilians, and conduct medical assays for detection of illness or other medical conditions. All of these medically important consumable products must be kept within an optimum range of temperatures to prevent spoilage or damage to the active proteins within them. Vaccines and assays in particular are subject to irreversible damage from freezing and must be protected from subfreezing temperatures as well as well as from high temperatures. Currently the Navy fields a medical refrigeration system that is energy inefficient and has only two settings: a Refrigerator mode of +4°C (39.2°F) and a Freezer mode of -22°C (-7.6°F), making it difficult to maintain the specific temperature ranges required for certain vaccines and reagents and doing little to protect frost-sensitive products. To achieve this capability, the Expeditionary Medical Refrigeration Unit shall be able to maintain a user defined internal temperature to within -0, +2°C (-0, +3°F) of set point throughout an ambient operating temperature range of -32 – 52°C (-25 – 125°F) in a tactical environment (Role 1 to Role 2, primarily the Battalion Aid Station (BAS), Shock Trauma Platoon (STP), Forward Resuscitative Surgical Suite (FRSS) and Laboratory Equipment AMALs). The range of selectable internal temperatures shall be between -35°C and 25°C (-31°F – 77°F) Threshold; between -65°C and 25°C (-80°F – 77°F) Objective. The unit shall have minimum net capacity (output) of 30 watts thermal (102 Btu/hr) at a thermostat setting of 8°C and 40 watts thermal (136 Btu/hr) at a thermostat setting of 2°C (at 25°C ambient temperature). To protect frost-sensitive medical products such as vaccines from extreme cold the unit shall include an auxiliary heating capacity of not less than 30 watts thermal (102 Btu/hr). The unit shall have an internal payload volume of no less than 56.6 liters (2 ft3) with no internal payload dimension less than 33.0 cm (13 in), external dimensions not to exceed 100 cm (39.5 in) in any dimension, and a tare weight not to exceed 66 kg (145 lb). The device must support USMC energy efficiency goals by operating from a self-contained power source (such as batteries) for up to 24 hours Threshold; 48 hours Objective and shall utilize standard USMC field power for both direct power and battery recharging (110/220 VAC and 12-32 VDC). Designing for energy efficiency and minimal power consumption will be a primary objective of this program. The device must conform to MIL-STD-810G for environmental readiness, including storage at temperatures of -25 to 160 degrees F and operation at temperatures of -25 to 130 degrees F, the ability to withstand transport shock and vibration, ability to withstand operational drop of 36 inches and storage drop of 48 inches, ability to withstand settling sand and dust and blowing rain, and ability to operate at altitudes of up to 10,000 feet. The device shall be capable of achieving FDA 510(k) clearance for medical devices with submission for 510(k) being a key performance parameter of this device. Devices must be fully self-contained and designed for organic supportability by qualified active duty biomedical engineering technicians.

PHASE I: The small business will develop concepts for an Expeditionary Medical Refrigeration Unit that meets the requirements discussed in the Description section. The small business will demonstrate the feasibility of the concepts in meeting Marine Corps needs and will establish that the concepts can be developed into a useful product for the Marine Corps. Feasibility will be established by material testing, as appropriate. The small business will provide a Phase II development plan with performance goals and key technical milestones, and that will address technical risk reduction.

PHASE II: Based on the results of Phase I and the Phase II development plan, the small business will develop an initial Expeditionary Medical Refrigeration Unit prototype for evaluation. The prototype will be evaluated to determine its capability in meeting the performance goals defined in the Phase II development plan and the Marine Corps requirements for the Expeditionary Medical Refrigeration Unit. System performance will be demonstrated through prototype evaluation over the required range of parameters including numerous deployment cycles. Evaluation results will be used to refine the prototype into an initial design that will meet Marine Corps requirements. The small business will prepare a submission package for FDA 510(k) clearance with the assistance of and sponsorship by the Marine Corps. The small business will prepare a Phase III development plan to transition the technology for commercial and Marine Corps use.

PHASE III DUAL USE APPLICATIONS: If Phase II is successful, the company will be expected to support the Marine Corps in transitioning the technology for Marine Corps use. The company will deliver the Expeditionary Medical Refrigeration Unit for evaluation to determine its effectiveness in an operationally relevant environment. The company will achieve FDA 510(k) clearance for the device and will support the Marine Corps for verification testing and validation to certify and qualify the system for Marine Corps use. The company will support the Marine Corps in the training of users and maintainers and the development of commercial users’ and maintainers’ manuals. Private Sector Commercial Potential: The Expeditionary Medical Refrigeration Unit will be an FDA 510(k) certified commercial medical device that can be used in civil and industrial medical use. Potential private sector users include hospitals, clinics, paramedics/EMTs, search and rescue teams, disaster relief organizations, and other industries where medical grade products must be kept at a precise temperature.

REFERENCES:

  • UL 471, Standard for Commercial Refrigerators and Freezers. http://ulstandards.ul.com/standard/?id=471_10
  • Solar-Powered Refrigeration System, NASA Johnson Space Center. https://www.nasa.gov/centers/johnson/techtransfer/technology/MSC-22970-1_Solar-Refrigerator-TOP.html
  • Operating Instruction Two-Temperature Hemacool, Advanced Technology Blood Product Storage and Transport Refrigerator/Freezer Model HMC-MIL-1 of May 2005. http://www.steelsoldiers.com/upload/misc/HemaCool_Operations_5_13_05.pdf
  • Code of Federal Regulations Title 21, Part 640, of 1 Apr 2015. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=640
  • Department of Defense. MIL-STD-810G, Department of Defense Test Method Standard: Environmental Engineering Considerations and Laboratory Tests. 31 Oct 2008. http://www.atec.army.mil/publications/Mil-Std-810G/Mil-std-810G.pdf

KEYWORDS: Medical refrigeration, medical devices, blood products, vaccines, immunizations, medical

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