BEFORE THE TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

February 20, 2003

Presented by Kay R. Gregory, MS, MT(ASCP)SBB

Director, Regulatory Affairs, AABB

The American Association of Blood Banks (AABB) is the professional society for over 8,000 individuals involved in blood banking and transfusion medicine and represents approximately 2,000 institutional members, including blood collection centers, hospital-based blood banks, and transfusion services as they collect, process, distribute, and transfuse blood and blood components and hematopoietic stem cells. Our members are responsible for virtually all of the blood collected and more than 80 percent of the blood transfused in this country. For over 50 years, the AABB's highest priority has been to maintain and enhance the safety and availability of the nation's blood supply.

On June 27 of last year, AABB delivered a presentation before the advisory committee stating its belief that lack of appropriate data is a major barrier to determining the state of the blood supply in the United States. Although public health experts and the transfusion medicine community recognize the need for such data, and committees such as this one routinely ask for this information, no agency is willing to fund a comprehensive ongoing collection and analysis of data by an independent non-government organization. In particular, this committee has regularly mentioned the lack of data about travel to various countries and expressed concern about being able to predict the effect of expanding vCJD travel deferrals to other countries on the availability of the blood supply. This is but one example of the need for data that AABB certainly agrees is necessary – but for which no funding is available. It seems that everyone wants data, but no one is willing to fund it.

The committee asked for information concerning the effect of the new vCJD deferral criteria that went into effect October 31, 2002. Quantifying the effects of the new vCJD deferral is next to impossible. The same difficulties in measuring the effect of new donor policies that were discussed during previous meetings of this committee with regard to the initial round of vCJD deferrals are also applicable here. That is, it may be possible to measure how many donors appear at the blood center and are deferred because of vCJD criteria. However, we cannot measure how many donors self-defer because of the advance publicity, including significant efforts on the part of many blood centers to notify donors of the change. The committee should also keep in mind that the number of deferred donors does not equate to the number of blood components that are lost. Apheresis donors can donate more often than whole blood donors and can donate multiple components. Deferral of such donors increases the number of blood components that cannot be collected.

In addition, because there is no systematic, scientifically valid, routine collection of data concerning supply and usage, there is no established baseline, and thus it is impossible to measure the effect of policy changes such as the new vCJD deferral criteria.

The AABB encourages this committee to define data that it believes are essential for making sound policy decisions, and to vigorously urge government funding of data collection by an independent non- government organization.