Irradiation
Overview
Blood and blood components often are irradiated prior to transfusion to prevent the proliferation of certain types of T lymphocytes that can inhibit the immune response and cause graft-versus-host disease. This procedure is necessary for transfusion recipients at risk for GVHD, including fetuses receiving intrauterine transfusions, select immunocompetent or immunocompromised recipients, patients undergoing hematopoietic transplantation, individuals receiving platelets selected for HLA or platelet compatibility, and individuals receiving units from blood relatives.
Irradiation is performed using cesium-137 or cobalt-60 in self-contained blood irradiators or hospital radiation therapy machines. The amount of cesium or cobalt in these machines exceeds the minimum levels for radioactive units as defined by the Nuclear Regulatory Commission — an independent government agency that regulates the use of nuclear materials through licensing, inspection and enforcement of its requirements. Therefore, blood establishments with irradiators must be licensed by the commission. States and cities may have additional inspection and licensure requirements for these establishments.
On behalf of the transfusion medicine community, AABB works directly with the Food and Drug Administration to ensure appropriate irradiation guidance and regulations for blood products. AABB also communicates with the NRC to ensure the needs and concerns of the blood community regarding security and compliance with radioactive material requirements are conveyed to the commission.
Recent Actions:
7/31/08
The Nuclear Regulatory Commission announces that it will be conducting a public meeting to solicit input on issues associated with the use of certain forms of cesium chloride, or CsCl, currently used by NRC licensees and Agreement State licensees.
12/13/07
A Federal Register notice is published releasing an order from the Nuclear Regulatory Commission imposing fingerprinting and criminal history records check requirements for individuals with unescorted access to certain radioactive material, including blood irradiators.
6/5/2007
NRC releases regulatory issue summaries 2007-14 and 2007-15 that outline requirements for individuals with unescorted access to radioactive materials to undergo fingerprinting and FBI criminal records background checks to be consistent with requirements for manufacturers and distributors.