FDA Perspective

The U.S. Blood Supply

Am Fam Physician. 2000 Jan 15;61(2):549-550.

According to a recent study, the supply of blood products available for transfusion in the United States may not be sufficient to keep up with an increasing demand associated with declining blood donations. A comprehensive survey of blood collection facilities and transfusion services that was conducted in 1998 by the National Blood Data Resource Center (NBDRC), an independent organization funded by the American Association of Blood Banks, yielded the following findings:

  • There were 11.7 million random allogeneic blood donations in 1997, a 0.3 percent decline from 1994. (Nearly all such donations are voluntary and nonremunerated.)

  • Total whole blood collections (allogeneic, autologous and directed) showed a 5.3 percent decline over the same period because of large decreases in autologous and directed donations. Autologous donations decreased by 36.5 percent, and directed donations decreased by 38.6 percent.

  • Blood utilization increased by about 1 percent each year.

  • Linear extrapolation of the data suggested that demand will exceed supply sometime in the year 2000. Although a subsequent report by the U.S. General Accounting Office concluded that the NBDRC overstated the decline in the blood supply, the potential for a blood shortage in the short term has increased because of the implementation of new donor deferrals as a precaution against the theoretic possibility of bloodborne transmission of new-variant Creutzfeldt-Jakob disease. The latter has been linked by laboratory and epidemiologic studies to an outbreak of bovine spongiform encephalopathy in the United Kingdom, most likely associated with consumption of affected beef products. Although there is no evidence of blood transmission of new-variant Creutzfeldt-Jakob disease, a theoretic risk cannot be ruled out at this time and is being taken seriously by the Public Health Service (PHS).

As part of the government response, the U.S. Food and Drug Administration conducted a comprehensive review of this theoretic risk of transmission at a public meeting of an FDA scientific advisory committee in June 1999 and, on the basis of this review, issued guidance for blood centers in August. Because the epidemic of bovine spongiform encephalopathy infection in cattle began in the United Kingdom in 1980 and posed a threat to food safety in the United Kingdom until late 1996, the FDA recommended to blood centers, as a precautionary measure, to indefinitely exclude potential donors who spent six or more cumulative months in the United Kingdom during that 16-year period. It is estimated that the exclusion of such donors will reduce the theoretic risk of new-variant Creutzfeldt-Jakob disease 10-fold while decreasing the national blood supply by approximately 2.2 percent. The impact, however, could be higher in some regions.

At the request of David A. Satcher, M.D., Ph.D., the Assistant Secretary for Health and Surgeon General, the projected blood shortage was considered last summer by a group of blood experts representing the FDA and its Blood Products Advisory Committee, the Centers for Disease Control and Prevention, the National Heart, Lung, and Blood Institute and the Department of Defense. Following discussions that included presentations by several members of the blood industry, the group identified the five following strategies to monitor and increase the blood supply.

Monitoring the Blood Supply

There are no reliable, timely data on national and regional blood collections and blood use. The study group recommended that an appropriate agency within the PHS arrange for ongoing monitoring of the nation's blood supply to generate data that can be used by government and blood centers to forecast and respond to developing blood shortages. NHLBI already has committed funds for a three-year pilot program within the private sector to implement this monitoring.

Encouraging More Donations by Eligible Donors

Nearly one half of the U.S. population over 17 years of age is estimated to have donated blood at least once, but only 5 percent of eligible donors give blood in any year. Also, among active donors, the average number of donations is 1.5 times per year, although whole blood can be donated up to once every eight weeks, or six times per year. It has been estimated that a 15 percent increase in the number of donations per donor per year would increase the national supply by 10 percent. To address this issue, the PHS is encouraging and will cooperate with an industry-developed, broad-based national media campaign to increase voluntary blood donations. Health care providers and various institutions will be called on to support this campaign.

Improving Donor Recruitment and Retention

In recent years, recruitment and retention of donors has been negatively affected by increasingly stringent donor deferral criteria. Repeat donors have reported that they find the donor questionnaire extensive, intrusive and tedious, and that blood donation often is inconvenient. In response, the PHS and blood industry plan to cosponsor a public workshop to identify “best practices” for donor recruitment and retention. The questionnaire for donors will be re-evaluated based on a careful review of the safety implications of any proposed changes.

Removing Some Donor Restrictions

Policies on blood collection that may unduly restrict some safe donations will be carefully re-examined in scientific studies and public workshops. The FDA has already announced a policy change regarding therapeutic bleedings for patients with hemochromatosis who require phlebotomy as therapy for iron overload and are deferred as routine blood donors. The deferral is based on a concern that the financial incentive of a cost-free blood donation (rather than a paid therapeutic phlebotomy) might cause donors to fail to acknowledge risk behaviors that would be grounds for deferral. The FDA has announced that donations by patients with hemochromatosis will be permitted without requiring special product labeling at blood centers that can provide documentation showing that they do not charge for therapeutic phlebotomies.

Addressing Economic Issues in the Blood Industry

Economic issues faced by the blood industry indirectly affect the blood supply through their impact on business practices and competition to recruit donors. The U.S. Department of Health and Human Services is reviewing its current policies on reimbursement for blood services, but continued reliance on unpaid volunteer blood donations remains a fundamental safety measure.

Jay S. Epstein, M.D., is the Director of the Office of Blood Research and Review at the Center for Biologics Evaluation and Research for the U.S. Food and Drug Administration.

Coordinator of this quarterly series from the U.S. Food and Drug Administration is Mike Kubic of the Office of Public Affairs.


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