Blood and blood products include components —e.g., plasma, platelets, packed red cells - of whole blood, which is routinely used in surgery and other medical procedures.
The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER works closely with other parts of the Public Health Service (PHS) to identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products.
Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products. Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors. FDA requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them. Blood donations are tested for the following seven different infectious agents:
Hepatitis B virus
Hepatitis C virus
Human Immunodeficiency virus Types 1 & 2 (HIV)
Human T-Lymphotropic Virus Types I and II (HTLV)
Treponema pallidum (syphilis)
West Nile virus (WNV)
In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry by inspecting all blood facilities at least every two years. "Problem" facilities are inspected more often. Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers. While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer now than it has ever been. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of FDA is to drive that risk to the lowest level reasonably achievable without unduly decreasing the availability of this life-saving resource.