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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 works with the NRC to communicate the needs and concerns of the blood community regarding security and compliance with radioactive material requirements.

Recent Actions

4/12/12
The Radiological Devices Panel of the Medical Device Advisory Committee met to advise FDA on the device classification of blood irradiators. In its public statement, AABB recommended that no measures be added for use of blood irradiators and that the devices be classified as class I or II. After discussions, the panel advised FDA that class II with general and special controls would be appropriate.

6/29/10
The NRC proposes to adopt a statement of policy on the protection of cesium-137 chloride sources. Among NRC's positions is that the use of alternative forms of cesium-137 is desirable, but near-term replacement is not practicable or necessary due to implementation of additional requirements already in place and considering the lack of a disposal capacity.

6/15/10
The NRC proposes to amend its regulations to establish security requirements for the use and transport of category 1 and category 2 quantities of radioactive material to prevent theft or diversion.

1/21/10
The NRC, in cooperation with the U.S. Department of Energy’s National Nuclear Security Administration, or NNSA, publicizes a program under the Global Threat Reduction Initiative (described in RIS 2010-02) whereby the NNSA, working with the NRC, will assist agreement states and licensees regulated by the NRC with the implementation of voluntary security enhancements. The enhancements are in addition to any requirements of the NRC and are provided at no cost to the licensee.

1/4/10
The NRC issues additional "trustworthiness and reliability" requirements to maintain appropriate access to certain radionuclides and to allow manufacturing and distribution licensees and non-M&D service provider licensees to have the same level of access to these materials at medical facilities.

4/17/09
The NRC announces that it will not ban CsCl sources, allowing the continued use of blood irradiators. The commission agreed with the position presented in a November 2008 report that near-term replacement is not realistic and would be harmful to the delivery of medical care, research and emergency response capabilities.

10/13/08
AABB submits comments to the NRC on the security and continued use of cesium-137 chloride sources, which are used in blood irradiators, addressing NRC's four areas of interest detailed in a July 31 Federal Register notice: the feasibility of using isotopes other than cesium-137 for irradiators or alternative technologies, the potential for phasing out cesium-137 chloride sources, and the possibility of additional enhanced security requirements.

9/29-30/08
The NRC states at a public meeting on the security and continued use of cesium chloride, or CsCl, sources that any decisions regarding their continuation will incorporate sufficient time to transition to alternative sources or technology, will limit the impact on the health care of patients, and will proceed through the official rule-making process. AABB presents responses to four questions posed by the commission in the July 31 Federal Register notice.

7/31/08
The NRC 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.

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