Blood Safety: Enhancing Safeguards Would Strengthen the Nation's Blood Supply.Statement of Bernice Steinhardt, Director, Health Services Quality and Public Health Issues, Health, Education, and Human Services Division

摘要

Donors give approximately 14 million units of whole blood and 12 milllion unitsof plasma annually. As many as 4 million patients receive transfusions of whole blood components and millions more receive plasma products each years. Since the human immunodeficiency virus (HIV) was introduced into the U.S. blood supply in the early 1980s, the benefits of a potentially life-saving transfusion have had to be weighed against the risk of acquiring this deadly disease through blood transfusion. Widespread concern about the safety of the blood supply has led to many positive changes in the way blood is collected, processed, and transfused. In testimony on July 28, 1993, before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, the Commissioner of the Food and Drug Administration (FDA) outlined five overlapping 'layers of safety' that provided a framework for regulating and monitoring the blood supply industry.