Experience with OVERLY irradiated blood products?

As you are probably aware, it has been demonstrated that transfusion-associated graft-versus-host disease (TA-GVHD) can result from the transfusion of non-irradiated blood to immunodeficient, and in certain circumstances, immunocompetent patients. TA-GVHD can effectively be prevented in susceptible individuals by the irradiation of blood components prior to transfusion. Because TA-GVHD carries a high mortality rate, with death occurring in more than 90% of cases, blood irradiation has become standard practice before transfusion to certain groups of immunodeficient patients, and in situations where the donor of the component is a blood relative of the recipient, or the donor of the component is selected for HLA compatibility by typing or crossmatching. A blood banker in Maryland wants to know what level of blood product irradiation is at risk of damaging the product and causing harm to a transfusion recipient. The inquiring blood banker's hospital protocol requires the use of an indicator label (such as RadTag® or RadSure®) to provide unequivocal verification that blood units have been irradiated to the required dose. The indicator label is attached to the bag of blood before the blood is irradiated. The sensitive portion of this device is clear at the time it is attached to the unit. After irradiation, the label changes color.

Editor's NOTE: It is important to realize that such a label serves as a process indicator (for detection of inadequate irradiation) and not as a radiation dosimeter. Institutions performing blood product irradiation are urged to comply with good manufacturing practices to assure that your blood irradiator is delivering an appropriate dose (not too much, not too little) of irradiation to each blood product that is irradiated. The e-network might be interested in the Guidance for Industry document on Gamma Irradiation of Blood Products posted by CBER on Sept. 6, 2001.

The Maryland blood banker wants to know if any e-networker has experience with overly irradiated blood products, and if so, did this result in gross (or at least visible) hemolysis and/or patient harm. Is anyone aware of indicators that detect over-irradiation?

Editor's NOTE: The following links are to discussions or documents in the CBBS e-network archives or other sources that refer to irradiation of blood products. E-network members might find one or more of these documents/discussions of interest. 

• Should We Irradiate Red Cells Transfused to Patients with Sickle Cell Anemia?
• Is it necessary to irradiate cellular blood products for patients undergoing cardiac surgery?
• Questions on Cell Salvage During Cancer Surgery
• Concerns about potassium toxicity in transfusing low birth weight neonates
• Bioethical aspects of the recent changes in the policy of refusal of blood by Jehovah's Witnesses 
• Does QA Review All Manufacturing Records Prior to Release of Blood Products?
• AABB Comments on ISBT 128

The following response was submitted.

ADDENDA April 16, 2002

1. A representative of RADTAG® wrote that if any e-Network Forum member would like more information on how their above-cited product (RadTag) works, that information is available on their web site.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator