Abstract
The field of blood banking and transfusion medicine incorporates elements of blood donation and collection, blood component manufacture, pretransfusion testing including serology and molecular methods, blood transfusion therapy, and clinical consultation. Blood and blood components are regulated by the FDA both as biological products and as drugs. Blood collection primarily occurs in blood centers, whereas most transfusions are performed by hospital transfusion services. The primary blood components used in transfusion include red blood cells, platelets, plasma, and cryoprecipitate. Less frequently, whole blood is transfused, particularly in military situations. Further processing of blood and blood components may include leukocyte reduction, irradiation, washing, volume reduction, and CMV-serology testing. Indications for transfusion vary based on the clinical situation and individual patient characteristics. Significant adverse events of transfusion can be categorized into immediate reactions (e.g., acute hemolytic transfusion reactions (AHTR)) and delayed reactions (e.g., delayed hemolytic transfusion reactions (DHTR)). Transfusion-transmitted infection from viruses, bacteria, parasites, or other pathogens is another significant risk of blood transfusion. Measures used to mitigate the risk of transfusion-transmitted infection include donor screening procedures and testing of the blood supply for pathogens with various methods, as well as new technologies such as pathogen reduction.
As the practice of transfusion medicine continues to evolve, the importance of systemic blood transfusion surveillance, known as hemovigilance, has gained increasing recognition. Hemovigilance encompasses the spectrum of donor through recipient transfusion processes, in order to monitor, track, and respond to both infectious and noninfectious risks from blood transfusion. Risk-based decision-making is another initiative that has arisen in recent years, referring to the development of a framework to prioritize decisions regarding blood safety balanced by availability of the blood supply. Finally, health economics and cost-effectiveness are important considerations necessary to inform risk-based decision-making and ensure preservation of a safe and available blood supply.
This book chapter reflects the views of the author and should not be construed to represent FDA’s views or policies.
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Storch, E.K., Custer, B.S., Menitove, J.E., Mintz, P.D. (2019). Transfusion Medicine. In: Lazarus, H., Schmaier, A. (eds) Concise Guide to Hematology. Springer, Cham. https://doi.org/10.1007/978-3-319-97873-4_36
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