Reduce Patient Risk of Transfusion-Associated Sepsis

Cerus Final Intercept United States 3

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 5.19.3.1 of the 30th edition and 31st edition of Standards for Blood Banks and Transfusion Services

 The AABB has:

  • evaluated the effectives 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 for the use of apheresis platelets, leukocytes reduced, psoralen-treated (pathogen reduced) products as equivalent to irradiated platelets for patients at risk for transfusion-associated graft-vs-host disease (TA-GVHD)2 as follows:

BBTS 30th Edition-BBTS 31st Edition
(Effective April 1, 2016 and April 1, 2018 respectively)
Standard
Number
Standard Language available at: AABB Marketplace
5.19.3.1 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.

1. AABB. Standards for Blood Banks and Transfusion Services, in Chapter 5 - Process Control 2016 and 2018 AABB: Bethesda, MD. 

2. AABB. Association Bulletin #16-05: Changes to the 30th edition of Standards for Blood Banks and Transfusion Services.