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One in a Series of Information Sheets from FDA
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:
If any one of these safeguards is breached, the blood product is considered unsuitable for transfusion and is subject to recall.
For more information, call 301-827-2000 or visit www.fda.gov/cber/blood.htm.
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.
Publication No. FS 02-1
February 2002