FDA Approves Freeze-Dried Blood Plasma for US Troops on the Battlefield

Orange County, CA - August 15th, 2018 -  The U.S Food and Drug Administration (FDA) granted the U.S. Department of Defense (DoD) an emergency use authorization (EUA) approval of freeze-dried plasma (FDP) for use to treat injuries from combat. The EUA was given after a dispute over whether access would be allowed.

The United States is working on receiving approval for a new type of plasma. They currently use a substance known as Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma, which is manufactured by the Centre de Transfusion Sanguine des Armées (Blood Transfusion Center of the Armies). The use of the French plasma product is authorized under the EUA, for the treatment of hemorrhage or coagulopathy of U.S. military personnel. The FDA stated it should be used only during an emergency that involves agents of military combat such as projectiles, firearms, and explosive devices, when plasma is not available for use or when the use of plasma is not practical.

The FDA and the DoD’s Office of Health Affairs launched a joint program to prioritize the efficient development of the medical plasma product in January. “Through our collaborative program with the DoD, they’ve made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma. Granting this authorization will support access to this important product in the event it’s needed,” stated Dr. Scott Gottlieb, the FDA’s commissioner in the press release.

The French plasma product is primarily used where refrigeration is not available. The product is powdered, freeze-dried, and then stored in glass bottles. Medical personnel and physicians reconstitute the plasma with a vacuum pressure system. The FDA has been slow to approve the French product due to the glass bottles being heavy and damage-prone if not handled correctly, and the vacuum system requires a spiking process that can cause problems, if not performed precisely.

FDA Approves Freeze-Dried Blood Plasma for US Troops on the Battlefield

The U.S. Army Medical Materiel Development Activity (USAMMDA) is working with Vascular Solutions, Inc. to develop a more advanced, lighter plastic bag that uses a standard fluid transfer set to mix the product with sterile water for injection.“The plastic bag storage container that Vascular Solutions uses is made of polyvinyl chloride and has undergone extractable and leachable testing to ensure that the bag is biocompatible and safe. The product will also be put on stability studies to detect any changes in the FDP over time,” said Andrew Atkinson, product manager for the Pharmaceutical Systems Project Management Office at USAMMDA.

There are several proteins in plasma that are used as medicines that are extremely important. It’s used to help clot blood and stop bleeding and usually needs to be refrigerated. Freeze-dried plasma does not need to be refrigerated or go through a long thawing process the way normal frozen plasma does.  The final clinical study report is currently pending. The Army is hoping for approval and shipment to the troops in early 2019.

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FDA Approves Freeze-Dried Blood Plasma for US Troops on the Battlefield Orange County, CA – August 15th, 2018 –  The U.S Food and Drug Administration (FDA) granted the U.S. Department of Defense (DoD) an emergency use authorization (EUA) approval of freeze-dried plasma (FDP) for use to treat injuries from combat. The EUA was given after a dispute […]