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 and separated into major components prior to transfusion, automated collections have become common practice whereby the components that are needed for transfusion are the only ones collected.
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.
CareFusion provides a letter announcing FDA approval to update the ChloraPrep arm prep label to a thirty second dry time.
The AABB Interorganizational Task Force on Quarantine Release Errors released a white paper that addresses the issues of common terminology for discussing QREs, including a consensus definition for a QRE. The paper also explores work environment issues and human factors contributing to QREs.
FDA published the guidance for industry titled “An Acceptable Circular of Information for the Use of Human Blood and Blood Components.” The guidance recognizes the April 2013 Circular of Information as acceptable for use by manufacturers of blood and blood components intended for transfusion.
FDA announced a draft guidance for industry titled "Changes to an Approved Application: Biological Products — Human Blood and Blood Components Intended for Transfusion or for Further Manufacture." The guidance is issued to manufacturers of licensed whole blood and blood components intended for transfusion or further manufacture as well as source plasma. It provides recommendations to assist with determining the most appropriate reporting mechanism through which changes may be submitted to an approved biologics license application. The document also addresses applicability and content of comparability protocols as well as labeling changes. Once the guidance has been finalized, it will replace the document of the same title dated July 2001.
FDA announced its approval of the Hemerus Leukosep HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and Solx Additive Solution.
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.
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.
FDA issues draft guidance on pre-storage leukocyte reduction of whole blood and blood components intended for transfusion.