Have You Given Blood Lately? by FDA

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On this page:

FDA Oversight

Five Layers of Safety

Ongoing Safety Efforts

The Process of Donating Blood

Am I Eligible to Donate Blood?

Every day, hospitals throughout the United States are challenged by large

numbers of people who need blood. These people include victims of fires, motor

vehicle accidents, and other emergencies.

But it's not just accidents or trauma that prompt the need for blood. Blood is

required for many people, ranging from those with life-threatening illnesses to

others undergoing routine surgeries.

In fact, every two seconds, someone in America needs blood. This includes

cancer patients undergoing chemotherapy

people with sickle cell disease or other types of inherited anemia

organ transplant recipients

people undergoing elective surgery

women during and following labor and delivery

" Blood products are often lifesaving or life-enhancing, " says Midthun,

M.D., director of the Food and Drug Administration (FDA) Center for Biologics

Evaluation and Research (CBER). " FDA strongly encourages people who are in good

health to donate blood and to become regular blood donors.

FDA Oversight

FDA, through CBER, is responsible for ensuring the safety of the more than 15

million units of blood and blood components donated each year in the United

States. FDA's standards and regulations regarding blood donor selection, blood

donation, and processing help protect the health of both the donor and the

recipient.

" Some people are concerned that they might get an infection by donating blood, "

says Midthun. " Donating blood is a safe procedure. "

FDA's oversight of the blood industry includes

approving licenses for blood products

approving devices used for blood collection and infectious disease testing

developing and enforcing quality standards

inspecting all blood facilities at least every two years

inspecting " problem " facilities more often

monitoring reports of errors and adverse events

taking regulatory or legal actions if problems are found

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Five Layers of Safety

FDA's blood safety efforts focus on minimizing the risk of transmitting

infectious diseases, while maintaining an adequate supply of blood for the

nation. " 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, " says

Midthun.

This safety record is based on five layers of overlapping safeguards:

Donor screening. Donors are asked specific and direct questions about their

medical history and other factors that may affect the safety of their blood.

This " up-front " screening eliminates ineligible donors.

Donor deferral lists. Blood establishments must keep current a list of deferred

donors. They must also check all potential donors against that list to prevent

the use of blood from deferred donors.

Blood testing: After donation, blood establishments are required to test each

unit of donated blood for the following infectious disease agents:

Hepatitis B

Hepatitis C

Human immunodeficiency viruses (HIV) 1 and 2

Human T-cell lymphotropic viruses (HTLV) I and II

Treponema pallidum, which causes syphilis

In addition, FDA recommends that each unit of donated blood used for transfusion

be tested for the West Nile virus.

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 FDA when product deviations occur

in distributed products.

If a violation of any one of these safeguards occurs, the blood product is

considered unsuitable for transfusion and is subject to recall.

Ongoing Safety Efforts

Emerging threats to the blood supply and other potential risks mean FDA's Blood

Safety Team never stops looking for ways to improve blood safety. " We need to

continually work to preserve the safety and integrity of blood and blood

products, " says Midthun.

FDA scientists are working to develop sensitive donor screening tests to detect

emerging diseases and bioterrorist agents in blood donations. They are also

working to improve blood donor testing kits to detect variant strains of HIV,

West Nile virus, and hepatitis viruses. In addition, FDA's Office of Blood

Research and Review regularly looks at donor deferral issues to update

eligibility requirements when appropriate.

Also, FDA is a member of an interorganizational task force on domestic disasters

and acts of terrorism that includes blood organizations, government agencies,

and device manufacturers. As such, it works with others to help assure that

blood facilities keep safe and adequate inventories at all times in case of a

disaster.

The Process of Donating Blood

Blood is critically needed every day, yet only a small percentage of the

eligible U.S. population donates blood in any given year.

The entire procedure takes about an hour and includes

registering at the donation site

answering questions about your health and travel history

getting a limited physical examination

donating the blood (This takes about 15 to 20 minutes)

having a light refreshment to boost your energy level before leaving the

facility

Am I Eligible to Donate Blood?

To meet the basic requirements for giving blood, you must be healthy (feel well

and be able to perform normal activities) and

have a blood pressure within normal limits

have a normal temperature

be free from acute respiratory diseases

be at least 16 years old

have a normal blood hemoglobin level

not have donated blood in the last 56 days

A number of conditions, which will be discussed with you at the donation site,

may cause you to be temporarily or permanently ineligible to give blood. These

conditions include

not feeling well

past use of needles to take drugs that were not prescribed by a health care

professional

being a male who has had sexual contact with another male since 1977

getting tattooed in the last year (unless done under sterile conditions and at a

state-licensed facility)

living in or visiting certain countries during designated periods of time; for

example, living for a period of time in a country where bovine spongiform

encephalopathy (also known as mad cow disease) is found, or visiting an area

where malaria is found.

The rules for eligibility are less strict when making donations before surgery

for your own use (autologous donations).

This article appears on FDA's Consumer Updates page4, which features the latest

on all FDA-regulated products.

Revised October 19, 2010

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048368.htm