New Blood-Collection System Performs Selective Recovery

Promising to "revolutionize" whole blood collection methods, the new Trima Automated Blood Collection System awaits FDA approval for sale in the United States. Blood collection with the Trima system will be driven by demand rather than donor availability, says Bill Mercer, vice president of sales at COBE BCT (Lakewood, Colo.).

"Today, whole blood is obtained from a donor, then taken to a central facility for separation into various components. With our system, a donor might donate platelets only," explains Mercer. "The machine can collect any of the constituents of blood, in a final transfusable format, without secondary processing. Only HIV or HCV testing must be done separately."

The Trima system, based on COBE's successful Spectra apheresis (cell separation) technology, allows whole blood to be withdrawn from a donor, segregated into its various parts using centrifugal cell separation by density and weight, then returned to the donor with all but the desired component. While the technology is similar to Spectra apheresis, Trima employs different channels that allow more acute separation of components.

Trima's efficiency is enhanced by a multi-functional information system. Donor histories, for example, are maintained on a host system and downloaded as needed to determine machine settings. The information system also fosters a more statistical approach to quality assurance, with access to quality data that generally doesn't exist in conventional processes.

"The FDA is very stringent about quality compliance, so the goal in blood centers is to reduce process variability," states Mercer. While existing equipment allows blood collectors considerable flexibility—and the opportunity to diverge from process standards—the Trima machine completely controls the collection, offering built-in quality safeguards. The center administrator determines the process, and the collector carries out the process without any opportunity to make changes. In addition to reducing process variations, this reduces the skill level required of the collectors.

With safety and efficacy studies complete, COBE is moving into operational engineering studies to demonstrate how the Trima system effects the broader processes in a blood center. While the eventual price of the system is unknown, the real cost savings will come from utilization of products. States Mercer, "Today if you donate a unit of red cells, you'll get maybe 1.4 products that theoretically can be used in the community. By contrast, with the Trima system blood centers should get 2.3 - 2.5 transfusable products, targeted to specific needs, without compromising the donor." And, since more transfusable products per donor will decrease the number of donors needed, COBE foresees direct savings in lower recruitment costs and fewer donor tests. Indirect benefits include tighter process control and a more hybrid—therefore safer—donor panel.

By Laurie McCarthy