Blood Supply Fda Oversight And Remaining Issues Of Safety Report To The Ranking Minority Member Committee On Commerce House Of Representatives

Approximately 4 million patients annually receive life-saving transfusions of blood donated by 14 million donors around the nation. This report evaluates the Food and Drug Administration's "layers of safety" that provide the framework for regulating and monitoring the U.S. blood industry. Specifically, it examines the actual and potential vulnerabilities in the layers of safety that may present a threat to the public health. Addresses these potential vulnerabilities in light of changes in the blood industry that have occurred since the mid-1980s, when there was widespread concern about the safety of the nation's blood supply. Viral and non-viral agents are described.

Widespread concern about the safety of the blood supply has led to many changes in the way blood is collected, processed, and transfused. Consequently, the risks of contracting certain diseases, such as AIDS and hepatitis, are lower today than they were in the mid-1980s. This report addresses the risks of contracting AIDS and hepatitis from blood as well as other known risks of blood transfusion. It addresses disparate estimates of transfusion-associated AIDS and hepatitis cases and determines the current risks, evaluating the content and quality of data collected to assess these risks. Graphs. Extensive bibliography.