The top priority of the American Red Cross is the safety and availability of the blood supply. Clinical studies indicate that leukoreduced products provide many benefits for patients including a reduction in transfusion reactions and a decreased risk of antibody formation. The American Red Cross continues to believe leukoreduced blood products may lead to better patient outcomes. After serious consideration, however, a decision has been made to offer both leukoreduced and non-leukoreduced red cells to hospitals. The reasons for this decision include:

• The Red Cross continues to receive requests from hospitals to allow ordering physicians to decide which patients require leukoreduced blood products;
• Definitive clinical evidence demonstrating that leukoreduced products are necessary for all patients is not available; and
• There is an absence of anticipated regulatory action mandating leukoreduction by the Food and Drug Administration (FDA).

In September 1998, the Blood Products Advisory Committee of the Food and Drug Administration unanimously recommended the leukoreduction of all cellular blood products. Based on this recommendation, and information available at that time which supported universal leukoreduction, the Red Cross led the blood banking community in implementing leukoreduction of all blood products. The Red Cross red blood cell supply has been at virtually 100 percent leukoreduction since December 2001. An estimated of the current percent of leukoreduced red blood cell products in the U.S. market stands at 70 percent.

While the FDA has expressed support for the implementation of universal leukoreduction nationwide, the agency has not provided specific guidance or regulation mandating this action. It is not anticipated that this guidance is forthcoming.

The American Red Cross will continue to study, evaluate and monitor incoming data on the benefits of leukoreduction and will modify its policies in accordance with the latest scientific evidence.

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