Fratantoni and other CBER experts evaluated the committee's recommendations, as well as animal and human studies of the preparations. But promising possibilities are on the drawing board, and FDA is monitoring those possibilities. Meanwhile, working alternatives continue in the operating room and the pharmacy. The American blood supply is reasonably safe, and patients who need blood can accept it with confidence, according to Food and Drug Administration experts. But this doesn't mean that blood is entirely risk-free.
Blood is human tissue, a biological product, so it carries a degree of risk.
The risk from transfusion, however, is far less than the risk of not getting blood when it's needed. FDA's job is to enforce safeguards, such as questioning potential donors about risk behaviors, testing their blood for infection, quarantining donated blood until tests show it to be safe, and monitoring the blood banking system. In other words, FDA regulates blood banking much as it does manufacturers. Blood banks must meet quality control requirements comparable to those of the pharmaceutical industry and must ensure the safety of their commodities. As for shortages, the blood supply has its ups and downs, like any commodity, but this fluctuation does not mean there's not enough blood for transfusions, says Joseph Fratantoni, M.D., director of hematology at FDA's Center for Biologics Evaluation and Research, which regulates blood banks and blood products.