FDA Expands Indication for Blood Collection System from Terumo BCT

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.

According to the company, 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 storage bag for up to seven days post-collection in 100 percent plasma and up to five days in Isoplate Solution. 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.

“Collaborating with customers inspires our passion, innovation and quest to deliver higher levels of quality, safety and efficiency,” said Ballish. “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.”

Lakewood, Col.-based Terumo BCT, a division of Tokyo-based cardiovascular firm Terumo Medical Corp., makes blood component, therapeutic apheresis and cellular technologies.

Reference:
1. Hubbard B and B Fulmer, “Increasing Donor Satisfaction Through the Use of Single-Needle Procedures.” Transfusion 2009; 49 (Suppl.): 250A.