LAKEWOOD, Colo.--(BUSINESS WIRE)--Terumo BCT has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a labeling change, extending the storage of platelets in plasma from five days to seven days, as well as offering wireless capability for the software applications used with the Terumo BCT Trima Accel® Automated Blood Collection System. Both capabilities are designed to improve operational efficiencies and streamline workflows for blood centers.
“The seven-day platelet storage and wireless option designed for the Trima Accel system demonstrates our ongoing commitment to provide customers with a flexible platform, delivering the most blood component collection options to maximize a blood center’s operations and realize greater productivity—whether in fixed or mobile sites,” said Greg Ballish, Vice President, Blood Centers Segment at Terumo BCT.
The extended storage for platelets in plasma collected with the Trima Accel system will help blood centers better meet changing patient needs at hospitals, improving the ability of blood centers to provide the right product at the right time. This clearance adds to the flexibility and productivity of the Trima Accel system, a device that offers single-needle procedures for a more comfortable donation experience.1
The platelet storage conditions have been verified for the standard Terumo BCT extended life platelet (ELP) storage bag for up to seven days post-collection in 100 percent plasma and up to five days in Isoplate Solution (PAS-F). This is a two-day extension from previous standards for storage of platelets in plasma. For platelet storage up to seven days, the clearance requires that every product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”
The wireless feature connects the Trima Accel system to key software applications such as the Cadence® Data Collection System and the Vista® Information System through the blood center’s or hospital’s existing wireless network. This enables access to electronic donor information and reporting capabilities—streamlining collections, simplifying data management and allowing operators to focus on donor care, even when a wired connection is unavailable.
- The FDA gave 510(k) clearance to Terumo BCT for a labeling change, extending the storage of platelets in plasma to up to seven days and adding a wireless feature that enhances the mobility and flexibility of the Trima Accel system
- The Trima Accel system expands the global product portfolio of Terumo BCT, the only company with the unique combination of apheresis collections along with manual and automated whole blood processing
- The clearance offers more flexibility to blood centers for platelet storage and distribution and enhances reporting capabilities in a mobile environment
- The wireless feature enables blood centers to either purchase a compatible wireless appliance from Terumo BCT or choose an appliance of their own for attachment to the Trima Accel system using a mounting bracket on the back of the system
- The submission cleared by the FDA is 510(k) BK150269
The Cadence Data Collection System collects and transfers information
Terumo BCT devices to a team of support professionals who can then provide comprehensive reports, so customers can reduce technical interruptions in a timely manner
- The Vista system aids operators with donor records, automated blood loss tracking, optimized component combinations and more, providing advanced donor management information and handling administrative tasks so blood centers can focus more on patient care
Greg Ballish, Vice President, Blood Centers Segment Product Marketing
“Collaborating with customers inspires our passion, innovation and quest to deliver higher levels of quality, safety and efficiency. This clearance from the FDA shows our commitment to continuous product improvement for our customers. The seven-day storage option and wireless capability provide blood centers enhanced capabilities for donor and inventory management while improving operational efficiencies, which help control operating costs. We are pleased with these FDA clearances and look forward to future opportunities to better serve our customers, the donors and the patients we all ultimately serve.”
About Terumo BCT:
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
1Hubbard B and B Fulmer, "Increasing Donor Satisfaction Through the Use of Single-Needle Procedures." Transfusion 2009; 49 (Suppl.): 250A.