Make Your Own IV Fluid

THE 77TH AERONAUTICAL SYSTEM GROUP IS CURRENTLY INVESTIGATING SYSTEMS THAT CAN CREATE FLUIDS FOR MEDICAL USE IN FAR FORWARD LOCATIONS.

Intravenous resuscitation is a critical therapeutic treatment capability that medical personnel must have to administer intravenous fluid (IV) solutions throughout military battle operations. Currently, the military services meet this requirement by transporting prepackaged IV solutions to forward-deployed medical elements and locations, using valuable airlift capacity to haul what is largely water. The climactic conditions in forward-deployed locations often expose IV fluids to temperatures outside recommended limits for extended periods of time. Extreme weather conditions combined with limited environmentally controlled storage increases shelf-life and transport risks, frequently resulting in IV fluid disposal and logistical re-supply operations.

Field intravenous reconstitution (FIVR) is envisioned to be an integrated medical component system capable of producing a variety of packaged IV fluids in quantities large enough to support field medical treatment facilities (MTF) that provide emergency resuscitative surgery and critical care. Military surge operations could result in mass casualty scenarios, potentially exhausting a deployed medical element or MTF’s entire stock of IV solutions, severely impacting patient recovery and survivability.

The 77th Aeronautical System Group, Brooks Base, Texas, is currently investigating technology solutions to meet this requirement. Successfully developing FIVR would provide the Air Force an inherent expeditionary medical advantage by reducing the amount of lift, storage and waste for needed IV solutions. The local production of fluids mitigates the danger of not having enough fluids for sustained operations.

The objective of FIVR is to design and develop an FDA-approved Environmental Protection Agency-quality water-source processing device consisting of integrated medical grade components. The device must be capable of producing packaged IV fluids for use by medical personnel in forward-deployed environments supporting initial and sustained military operations. It must be employable in medical care level II (or higher) deployed MTFs to provide resuscitative and surgical medical care to stabilize patients for evacuation.

Starting with an EPA-quality water source, a stand-alone FIVR device will produce a variety of FDA-approved IV solutions to include normal saline, half saline, dextrose and lactated Ringers. With this the device must be operable by a single person.

BREADBOARD MODEL
 
The current plan is for interested companies to submit a breadboard (also referred to as a proof-of-concept) model. For the system development and demonstration phase of the program, the preliminary device must still meet all threshold requirements.

A breadboard model consists of integrated components that provide a representation of a device or system that can be used to determine concept feasibility and to develop technical data. Typically, a breadboard is configured for laboratory use and testing to demonstrate the technical principles of immediate interest and may resemble the final system in function only.

KPPS

At this point, the breadboard device must meet four key performance parameters.

The first is that the system must interface with systems to use EPA-quality source water as the input to produce sterilized water for injection (SWFI), lactated Ringers, normal saline, half normal saline and dextrose 5 percent normal saline (D5NS) as intravenous fluids. The temperature range for the source water and system is between 33 and 140 degrees Fahrenheit.

Second, the produced fluids must meet USP Standard 29 for sterile water and IV fluid mixtures.

Third, the system must produce FDA standards compliant IV fluids to include sterile water, normal saline, half saline, dextrose and lactated Ringers.

Last, it must be able to full IV bags with SWFI to produce FDA-compliant packaged, sterile IV fluid solution, meeting all stipulations in USP and FDA.

NEXT STEP—SDD

The SDD device must meet only two but similar KPPs. It must produce FDAapproved fluids in deployed locations and the source water must meet EPA standards (STANAG 2136). As with the breadboard, the SDD device must produce EPA-quality source water as the input to produce SWFI, lactated Ringers, normal saline, half normal saline and D5NS as intravenous fluids. There are several additional parameters that the 77th is looking for.

For production rates, the FIVR will have to be able to produce the fluids at 10 liters in 60 minutes at a minimum. The preferred rate would be 20 liters in 60 minutes. The minimum shelf life capability is 72 hours but four weeks is preferred. As far as waste effluent, the system can produce no more than 20 percent at the top end with a preference to only 5 percent waste.

Physically, the device is expected to have a total empty weight of not more than 200 pounds. Less than 100 pounds is preferred. Retractable and lockable wheels are anticipated to ease transport, movement and maneuverability. Dimensionally, the device should take up less than 27 cubic feet although the preferred size would be no larger than six cubic feet.

Power consumption is based on 110/220 volts alternating current (50/60 hertz) and requires no more than 6 kW as the threshold with a preference for no more than 2 kW.

The storage temperature range has also been tightened for the SDD phase. The anticipated range at this point would be between 59 degrees and 86 Fahrenheit. The preferred range would be between 45 and 100 degrees Fahrenheit.

To keep watch over the system, the device is expected to have a fail-safe monitoring system to verify and validate the operating parameters like the filter performance, specific gravity and packaging. Tied to this would be an audible or visual alarm capability to alert operators to significant system performance malfunctions.

From time of being removed from the shipping container, or long term storage, the system should be operational within 45 minutes with a preferred goal of 20 minutes.

PUSHING FORWARD

Every time a consumable item can be either acquired or manufactured in far forward locations, that lessens the burden on the supply chain. Items like IV fluids and oxygen are perfect requirements that technological solutions can fulfill. ♦

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