Standards & Policies
AABB Standards and TA-GVHD Prevention
The American Association of Blood Banks (AABB) Blood Bank Transfusion Services (BBTS) Standards Program Unit (SPU) oversees the standards for irradiation of blood products, and maintains regulatory oversight for compliance with the standard for the irradiation of Blood Products as outlined in AABB Standard 5.19.4.1 of the 30th edition, 31st edition, and 32nd edition of Standards for Blood Banks and Transfusion Services
The AABB has:
- evaluated the effectiveness of the FDA approved pathogen reduction process on T-Cells1
- issued a new standard indicating the equivalence to gamma irradiation
The AABB has issued standards which accept apheresis platelets, leukocytes reduced, and psoralen-treated (pathogen reduced) products to be equivalent to irradiated platelets for those patients who are at risk for transfusion-associated graft-vs-host disease (TA-GVHD).2 The standard is as follows:
Standard Number 5.19.4.1
Methods known to prevent transfusion-associated graft-vs-host disease shall be used, and include either irradiation or the use of a pathogen reduction technology that is known to inactivate residual leukocytes and is cleared or approved by the FDA or Competent Authority.
Standard Language available at: AABB Marketplace
1. AABB. Standards for Blood Banks and Transfusion Services, in Chapter 5 – Process Control 2016 through 2020 AABB: Bethesda, MD. 2. AABB. Association Bulletin #16-05: Changes to the 30th edition of Standards for Blood Banks and Transfusion Services.