Performance Qualification of the ACP 215: Blood Bank of Hawaii's Validation Experience/Cobe 2991 Sunsetting

Course overview

This presentation outlines the Blood Bank of Hawaii's experience with validating the Haemonetics ACP 215. We will review our validation criteria for each FDA-approved protocol, as well as discuss some potential off-label applications. This presentation provides an overview of the COBE 2991 cell processor and its proven legacy in transfusion medicine and cellular therapy laboratories. It examines the implications of its discontinuation, including the operational, and patient care impact on blood banks, blood centers, and cellular therapy programs. Finally, it provides an overview of available alternative devices, including their FDA clearance status, capabilities, and limitations.