VOLUME 37, ISSUE 1

Grant Read, M.D.
CA-1 Resident
Baylor College of Medicine
Temple, TX

Riley Hedin, D.O.
Assistant Professor
Baylor College of Medicine
Baylor Scott & White Medical Center
Temple, TX

Craig J. Lilie, M.D.
TSA Newsletter Academics Editor
Assistant Professor and Residency Core Program Director
Baylor College of Medicine
Baylor Scott & White Medical Center
Temple, TX
Vein to Vein: Transfusion Medicine Review for the Anesthesiologist -Blood Banks
Overview and Regulation
The collection of blood and blood products, as well as the nation’s blood supply, are regulated by the United States Food and Drug Administration (FDA). The Center for Biologics Evaluation and Research (CBER) is the specific center within the FDA that regulates the collection of blood products to be used for transfusions or in the production of pharmaceuticals derived from blood or blood components. The FDA also establishes safety and quality standards for blood products in an effort to reduce associated risks. Hospitals and other establishments that collect, administer, or produce blood products are required to register and list their products with the FDA. These locations are also inspected at least every two years.(1) The Association for the Advancement of Blood and Biotherapies (AABB) and The Joint Commission also inspect organizations that deal with blood products. The AABB is a not-for-profit association that offers accreditation to blood organizations and helps set safety standards, promote research and development, and works with the FDA to aid in making regulations, policies, or research priorities to ensure a stable and safe supply of blood products.(2)
The United States blood supply relies heavily on volunteer blood donations from ~6.8 million volunteers annually. This represents about 3% of the US population, though approximately 62% of the US population is eligible to donate. The American Red Cross collects roughly 40% of the nation’s blood supply, while the remaining 60% is collected by community blood centers.(3) Requirements to donate, set forth by the FDA or AABB, can vary by institution and state and should be accessible on each blood institution’s website. Prior to donating, donors are required to pass a physical and health-history assessment. Healthy donors are encouraged to donate regularly.
Blood Products and Donation
The composition of blood includes red cells, white cells, platelets, and a liquid component, plasma. The most common form of blood donation is whole blood. Whole blood includes all parts of blood that can then be transfused in its original form or further separated into its components. Whole blood transfusions are relatively rare compared to the transfusion of individual blood components. The AABB recommends that institutions have policies in place to determine when a whole blood transfusion is indicated. Benefits of whole blood transfusions include increased oxygen carrying capacity, platelets, clotting factors, and volume expansion from a single product. This may be indicated for trauma patients, in pre-hospital settings, and in the military’s buddy transfusion system.(4) Most commonly, whole blood is spun in a centrifuge to separate the components into red cells, platelets, and plasma.
Blood donation may also be performed with apheresis, a process by which a machine is used to remove a specific blood component and return the remaining blood to the patient. The machine separates components using a centrifuge and can collect one or multiple components in one setting. Apheresis can be used to collect blood components from volunteer donors or can be used to treat various hematologic disorders or cancers.
Blood can be donated with an intended recipient in mind. Through designated or directed blood donation, a patient’s ABO compatible family member or friend can donate blood for them to use. Drawbacks include the requirement for a physician to submit a special collections order and a scheduled donation appointment with a delay in availability compared to immediately available cross-matched blood from an anonymous donor. Evidence has also shown that directed donations are associated with higher transfusion-transmitted infections when compared with blood donated by an anonymous volunteer, thought to be due to the stigma related to honestly revealing underlying diseases or risky behaviors.(5)
A patient can donate their own blood to be used in the future through a process called autologous donation. Autologous donation was more popular in the 1980s and 1990s due to fear of transfusion related infections. As safety standards have improved and transfusion related infections have decreased, autologous transfusions have become less popular. Autologous transfusions are still used to limit transfusion reactions in patients who have significant alloantiobodies.
Citations
- S. Food and Drug Administration – Center for Biologics Evaluation and Research. Blood establishment registration and product listing. Accessed December 16, 2024. https://www.fda.gov/vaccines-blood-biologics/biologics-establishmentregistration/blood-establishment-registration-and-product-listing
- Association for the Advancement of Blood & Biotherapies. AABB Accreditation Process. Accessed December 16, 2024. https://www.aabb.org/standards-accreditation/accreditation/become-accredited/accreditation-process
- America’s Blood Centers. U.S. Blood Donation Statistics and Public Messaging Guide. Accessed December 16, 2024. https:// org/statistics_guide/
- Cap AP, Beckett A, Benov A, et al. Whole Blood Transfusion. Mil Med. 2018;183(suppl_2):44-51. doi:10.1093/milmed/usy120
- Dorsey KA, Moritz ED, Steele WR, et al. A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010. Transfusion. 2013;53(6):1250-1256. doi: 1111/j.1537-2995.2012.03904.x