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U.S. Weighs Blood Safety and Supply Concerns

Emerging threats to the U.S. blood supply posed by new disease pathogens have compelled blood banks and government health officials to implement more aggressive donor screening measures. Consequently, by increasing the number of donor deferrals and introducing new screening tests approved by the U.S. Food and Drug Administration (FDA), blood bankers are growing concerned about significant reductions in the overall volume of blood donations. As reported in last month’s eNotes, the FDA approved the use of a new screening test for Chagas disease. The U.S. blood supply currently receives an adequate, though hardly robust, number of donations per year--only five percent of the eligible donor population actually gives blood.

Over the years, donor deferrals have continued to increase due to added restrictions and more thorough screening based on risky behaviors, new infectious diseases and travel to countries where blood-borne infectious disease agents are prominent. For instance, despite growing pressure from AABB (formerly American Association of Blood Banks), America’s Blood Centers and the American Red Cross to modify current regulations that prevent men who have had sex with men (MSM) since 1977 from donating blood, the FDA has kept this ban in place. The FDA has also enforced donor deferral policies among all blood donations from people who lived or visited the United Kingdom for three months or more between 1980 and 1996. The ban has been in place since 1999, in an effort to prevent variant Creutzfeldt-Jakob disease (vCJD) from entering the U.S. blood supply.

Most recently, the emergence of transfusion-related acute lung injury (TRALI) linked to particular antibodies found in the blood of women who have previously been pregnant, has necessitated caution. Deferring this segment of the population would affect 10% to 20% of female donors, up to one million women. AABB is recommending that blood collection centers institute procedures to reduce the risk of TRALI from plasma donations by November 2007 and from platelet donations by November 2008. Implementing these changes will undoubtedly shrink the donor pool.

Many in the field are forced to balance two often divergent, though equally important, needs—the need to maintain a sufficient number of donors while limiting risks to the blood supply. “There’s an endless barrage of emerging or expanding pathogens, and it’s a constant juggling act,” said Michael Busch, a transfusion medicine specialist and director of the nonprofit Blood Systems Research Institute in San Francisco.

While blood supply viability remains a concern for the foreseeable future, the FDA continues to takes a vigilant approach to donations. “For every deferral we put into place, we do a very careful consideration of how it will impact the donor pool,” said Alan Williams, PhD head of the Division of Blood Applications at FDA’s Center for Biologics Evaluation and Research. 

Source: Pittsburgh Post Gazette online (, January 10, 2007


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