Vascular Solutions, LLC, has been given U.S. Food and Drug Authority authorization for its Ezplaz Freeze Dried Plasma for transfusion in adults. Beginning in 2017, Public Law 115-92 made it possible due to lowering bureaucracy for products that could saves in emergency situations or countries where hospital infrastructure may not be developed enough.
In larger domestic hospitals, plasma is readily available but in combat zones or during disasters in remote areas, availability of it could be life or death. To help, FDA has given the green light to Ezplaz technology. It is freeze-dried plasma collected from FDA-licensed blood establishments and can be stored at room temperature. It is stable even after temperature fluctuations and is packaged in a plastic bag containing a foil pouch, a 250 mL bag of sterile water for injection, a sterile fluid transfer set, and a sterile blood transfusion set. Plastic reduced the risk of breakage.
FDA determined Ezplaz is as safe and effective as other plasma transfusion products, which means the benefit greatly outweighs the risk.
It is currently available in AB, A with low-titer anti-B blood types, chosen to reduce risk of emergencies transfusion before the blood type is known.
