Statement to the Food and Drug Administration's Blood Products Advisory Committee
03 December 2014
Blood Establishment Computer Software (BECS) and BECS Accessories
M. Allene Carr-Greer, Director, Regulatory Affairs
AABB is pleased to have this opportunity to provide comment to the FDA on the classification process for BECS and BECS accessories and agrees that the proposal made by the FDA to classify BECS as Class II is reasonable.
The difficulty today is determining “What is a BECS Accessory?” The FDA Executive Summary does not specifically define BECS accessories and frequently uses the phrase BECS/BECS accessory making it difficult to interpret what is a BECS, and what is a BECS accessory. Without a specific definition the combination of “identifying unsuitable donors” and “evaluate, determine, and track donor screening information and component history,” found in the Device Description portion of the Executive Summary Introduction (pages 6-7), potentially makes all equipment/devices that could have results electronically transferred/uploaded to the BECS, a BECS accessory.
AABB strongly recommends that the FDA provide more clarity around the definition of a BECS accessory before proceeding to rulemaking.
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.