FDA Establishes Rule Requiring Blood Centers to Notify Donors of Communicable Disease Status

The FDA ruled Friday that blood-drawing facilities must make "reasonable attempts" to notify blood donors who test positive for a communicable disease "or whose donation is otherwise unsuitable that they are deferred from future donations," Reuters Health reports. The final rule requires blood centers to provide the donor with the test results that show the donor has a disease such as HIV or hepatitis within eight weeks of testing. Blood centers must also provide donors with information and counseling on the condition (Reuters Health, 6/8). The final rule states, "Providing donors with accurate information about their communicable disease status and deferral as soon as possible helps ensure a healthy donor population" (Final rule text, 6/11). Blood centers must notify donors of their status in person, rather than by mail, as such a letter would be "'inappropriate' if a donor has a serious infection such as HIV," according to Dr. Mary Townsend, chair of the Scientific, Medical and Technical Committee of America's Blood Centers. Townsend added that the organization is "very satisfied" with the final rule, saying, "We got most of what we asked for." The rule goes into effect on Sept. 11 (Reuters Health, 6/8).