Overview
Blood, a living tissue circulating throughout the human body, is comprised of red blood cells, white blood cells, platelets and plasma. Although often collected as whole blood, donations typically are separated into these major components prior to transfusion. Facilities that collect and transfuse blood for specific treatment needs must follow individualized protocols for each component to help ensure that it remains viable for patient care.
In the U.S., the collection, testing, preparation, storage and transport of blood and blood components is governed by FDA regulations and guidance documents. On behalf of the transfusion medicine community and as part of ongoing collaborative efforts, AABB works directly with FDA and through government advisory committees to ensure the safe and effective collection and transfusion of blood products. In addition, AABB works with other federal agencies, including the Center for Medicare and Medicaid Services, to achieve adequate reimbursement for blood and blood products.
Recent Actions
9/25/12
FDA finalizes recommendations in a guidance document for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte-reduction process.
9/13/11
The Quarantine Release Errors in Blood Establishments Workshop provided a forum for discussion on quarantine release errors (QREs) and provided FDA and industry with information that indicated QREs are most frequently the result of human error and defects in process control.
1/31/11
FDA issues draft guidance on pre-storage leukocyte reduction of whole blood and blood components intended for transfusion.
2/8/08
The FDA issues a technical amendment responding to comments received on the direct final rule that revised the requirements for blood, blood components and source plasma.
1/11/08
The FDA announces the extension of the comment period to Aug. 4 for a proposed rule on the requirements for human blood and blood components intended for transfusion or for further manufacture.