Accelerating a Disposable-free Blood Warmer Prototype through FDA Clearance

With support from MTEC, Delta Development Team advanced the development of a Single Unit Blood Warmer (SUBW) device to a point that is now ready for 510(k) clearance by the U.S. Food and Drug Administration (FDA).

Over the last two decades, the United States has been challenged with military conflicts in Iraq and Afghanistan as well as domestic events that have raised concerns regarding the blood supply and blood products. Prior to this, the field of blood transfusion medicine witnessed significant advancements during the 20th century, including the discovery and classification of human blood groups, development of long-term anticoagulants, and initiation of the first blood collection program by the U.S. Government. Storage and use of whole blood far forward remains one of the best lifesaving methods available during traumatic injury. The product is a battery powered, portable, blood warming device designed specifically for military use. Different from other IV warming devices, this unit requires no water for thawing and no disposable tubes for warming. The only sterile component is a standard infusion kit. The SUBW will warm as many bags of blood as long as it is powered, versus other devices that are limited by expensive disposable electronics. The SUBW also has a built-in infuser. Future work includes the extension of regulatory clearance for warming bags of plasma.

In addition to the regulatory progress made during the award, Delta Development has made substantial headway into the civilian market. Delta has deployed their Autonomous Portable Refrigeration Unit (APRU) with local EMS programs who use this mini blood refrigerator in emergency vehicles to treat car crash victims that experienced extreme blood loss. They have also fielded their APRU in both Ukraine and Israel to deliver whole blood for transfusion to the front lines.

The research project award recipients were selected from the respondents to MTEC’s Request for Project Proposals soliciting medical technological solutions for prototype acceleration (Solicitation #MTEC-E22-05-PA).