DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 02-1

(FDA Web site: www.fda.gov)

February 2002

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.

For more information, call 301-

827-2000 or visit www.fda.gov/

cber/blood.htm.

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.