Blood & Blood Products
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 seven different infectious agents.
In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry:
- FDA inspects all blood facilities at least every two years, and "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 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.
Keeping Blood Transfusions Safe:
FDA's Multi-layered Protections for Donated Blood
Keeping the United States blood supply the world's safest is the ultimate responsibility of the nation's more than 3,000 blood establishments, which collect and process 14 million units of whole blood donated by volunteers each year. The Food and Drug Administration, however, has the vital role of ensuring that the 3.5 million patients who receive a blood transfusion in a year are protected by five layers of overlapping safeguards. This FDA blood-safety system includes the following measures:
- Donor screening: Donors are informed about potential risks and are required to answer questions about factors that may have a bearing on the safety of their blood. For example, donors with a history of intravenous drug abuse are routinely deferred. Since November 1999, the FDA has requested the blood industry to defer potential donors who had lived in European countries with reported or suspected cases of BSE, the "mad cow disease," and who might be carriers of the BSE agent.
- Blood testing: After donation, each unit of donated blood undergoes a series of tests for infectious diseases.
- Donor lists: Blood establishments must keep current a list of deferred donors and use it to make sure that they do not collect blood from anyone on the list.
- Quarantine: Donated blood must be quarantined until it is tested and shown to be free of infectious agents.
- Problems and deficiencies: Blood centers must investigate manufacturing problems, correct all deficiencies, and notify the FDA when product deviations occur in distributed products.
If any one of these safeguards is breached, the blood product is considered unsuitable for transfusion and is subject to recall.
Testing Blood
The FDA reviews and approves all assay test kits used to detect infectious and transmissible diseases in donated blood. Each unit must be tested for:
Hepatitis B and C viruses (HBV and HCV), which cause inflammation of the liver. The three tests used identify current and previous infection with HBV and HCV; detect a person who has recovered from a hepatitis B infection but continues to be a carrier for HBV; and identify carriers of even symptomless HCV.
Human Immunodeficiency Virus (HIV 1 and 2), which cause immunodeficiency disease, or AIDS. One test detects antibodies to proteins of both types of HIV virus, and another detects one of the viral proteins of the HIV-1 virus.
Human T-Lymphotropic Virus, Types I and II, which can cause infections that can lead to leukemia or a variety of neurologic diseases.
Syphilis. The test detects ongoing and previous infections with the bacterium that causes syphilis.
In addition, the FDA has licensed the first nucleic acid test systems for screening donors of whole blood and blood components, including fresh plasma, red cells and platelets. The semi-automated, highly sensitive systems can directly and rapidly recognize the genetic material of HCV and HIV, and thereby detect the infections before the appearance of their symptoms.
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