JOINT BASE LEWIS-MCCHORD, WA–The U.S. Army Medical Test and Evaluation Activity (MTEAC), in collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA) Program Executive Office (PEO) Soldier, Soldier Medical Devices (SMD), conducted a significant operational test of advanced blood storage technologies from August 16 to 19, 2024. This test was carried out with the support of the 153rd Medical Detachment, Blood Support (MDBS), and the 551st Medical Company-Logistics of the 62nd Medical Brigade.

The operational test aimed to determine the suitability, survivability, and reliability of several new blood management systems, including the Freezer Ultra Low Temperature (FULT), the Blood Plasma Freezer, the Platelet Agitator and Incubator (PIA), and the Dry Block Heat Incubator. These systems are potential replacements for the aging equipment currently used by the 153rd MDBS, which is approaching the end of its lifecycle.

To support the Army’s modernization efforts, these new systems feature advanced capabilities such as modern interactive displays and improved system performance. The goal is to address capability gaps in Army laboratories and blood centers, ensuring more effective storage, maintenance, and delivery of blood products to Soldiers in the field.

The operational test was strategically designed to coincide with the 153rd MDBS and the 551st Medical Company-Logistics’ scheduled Field Training Exercise, ensuring that the evaluation of the new systems aligned with their Mission Essential Task List (METL) and MOS Individual Critical Task Lists (ICTLs) requirements. This integration allowed the test scenarios to not only assess the new technologies’ performance but also enhance the units’ readiness through realistic training exercises.

Prior to the record test, personnel from both units underwent training on the new systems, preparing them to deploy and operate the equipment effectively during the exercise. The operational test included various scenarios designed to stress the MDBS’s capabilities in receiving, storing, and transporting blood products. These scenarios were crucial in assessing the systems’ performance and ensuring they meet operational requirements.

Following the test, participants convened to review and discuss the performance of the new devices. Feedback from test players, and their command teams, emphasized the importance of thorough testing and user involvement to refine and enhance the systems before potential fielding. The command team also highlighted the value of this comprehensive testing in improving the efficiency of blood banks and ensuring that life-saving medical care is readily available to support Soldiers in combat.

By advancing these blood management systems, the Army aims to improve the readiness and effectiveness of its medical support units, ultimately ensuring that warfighters receive timely and critical care in dynamic operational environments.

Aligned under the U.S. Army Medical Center of Excellence, MTEAC is the only independent operational test and evaluation agency of medical and medical-related materiel and information technology products, supporting of the Army and DOD acquisition process. To learn more about the U.S. Army Test and Evaluation Activity and their mission visit medcoe.army.mil/usamteac.

By Mr. Eitter Rodriguez, U.S. Army Test and Evaluation Activity

FORT DETRICK, Md. — A U.S. Army Medical Materiel Development Activity commercial partner received Emergency Use Authorization from the U.S. Food and Drug Administration for the Department of Defense to use octaplasLG Powder — a potentially lifesaving treatment option for blood replacement therapies in certain operational circumstances. Notice of the EUA for this product was received by the company, Octapharma USA, on Aug. 8, 2024.

USAMMDA’s Warfighter Protection and Acute Care Project Management Office, which has a Cooperative Research and Development Agreement with Octapharma USA, manages research and development efforts for several blood products, including Freeze-Dried Plasma, for the DoD. The EUA for octaplasLG Powder is a significant milestone in WPAC’s development mission, which includes blood replacement therapies for emergent care use during military operations and training.

“The WPAC team played a vital role in assisting our commercial partner under the CRADA, helping them navigate the EUA approval request and process to give our Warfighters another tool in their aid bag in far-forward environments,” said Kendra Lawrence, Ph.D., WPAC’s program manager. “While the octaplasLG Powder is not intended to replace current FDA-approved blood replacement therapies during emergency treatment, it does give medical commands and frontline providers added capabilities when facing possible shortages of traditional blood plasma in austere locations across the world.”

The EUA authorizes U.S. military medical commands to begin procuring octaplasLG Powder (blood types A and AB) and allows military medical personnel and other authorized providers to administer the lifesaving therapy to treat hemorrhage or coagulopathy when no other FDA-approved treatments, like fresh frozen plasma, are available — or when the use of traditional plasma is not practical in a compressed time continuum during military operations.

Blood loss is a significant threat to U.S. service members during combat operations and training, and treating hemorrhage or coagulopathy is imperative to saving the lives of the wounded and injured until medevac to higher echelons of care is arranged. Logistical and supply lines during future conflicts may stretch hundreds or thousands of miles, possibly causing shortages of FDA-approved blood products at and near the point of injury. Therapies like octaplasLG Powder are designed to serve as a stopgap when whole blood, fresh frozen plasma, or liquid plasma are in short supply, according to U.S. Army Maj. Andrea Mountney, WPAC’s military deputy project manager.

“During combat operations, whether in the Arctic, the Indo-Pacific, or other regions of interest, we will be facing the dual challenges of time and distance due to the austerity of those operating environments,” said Mountney. “Each passing second after a Service member is wounded or injured increases the complications caused by combat trauma. The longer it takes to begin blood replacement therapy, the higher the chances of mortality.

The WPAC team provides solutions for capability gaps, working with stakeholders across the DoD, academia, and industry to develop treatments that are affordable, reliable, and expeditionary,” she added. “Our goal is to meet the needs of the customer—the Joint Service end-user who may one day need these life-saving treatments. Solutions like octaplasLG Powder go a long way to equip our medical providers with the tools needed to treat the Warfighter during future operations.”

USAMMDA develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA Project Managers guide the development of medical products for the U.S. Army Medical Department, other U.S. military services, the Joint Staff, the Defense Health Agency, and the U.S. Special Forces community. The process takes promising technology from the Department of Defense, industry, and academia to U.S. Forces, from the testing required for U.S. Food and Drug Administration approval or licensing to fielding and sustainment of the finished product. USAMMDA Project Management Offices will transition to a Program Executive Office under the Defense Health Agency, Deputy Assistant Director for Acquisition and Sustainment.

No official endorsement of third parties or their products is made or inferred.

Read the FDA’s announcement

By T.T. Parish