Every day, hospitals throughout the United States transfuse blood or blood components, such as platelets, to save the lives of people who are in motor vehicle accidents, and victims of fires and other emergencies.
Blood is also required for many people with life-threatening illnesses and others undergoing routine surgeries. According to the Centers for Disease Control (CDC), an estimated 5 million patients receive blood annually.
In fact, every two seconds, someone in America needs blood, according to the American Red Cross (ARC). This may include:
- 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
- premature babies
- trauma victims.
Blood products from healthy donors are often lifesaving or life enhancing.
FDA, through the Center for Biologics and Research (CBER), is responsible for ensuring the safety of the more than the approximately 19 million units of whole blood donated each year in the United States. These donations can be further processed into blood components such as Red Blood Cells, platelets, and plasma. FDA's standards and regulations regarding blood donor selection, blood donation, and processing help protect the health of both the donor and the recipient.
FDA’s oversight of the blood industry includes:
- approving licenses for blood products
- approving devices used for blood collection, infectious disease testing and pathogen reduction technologies
- developing and enforcing quality standards
- providing guidance on emerging infectious diseases
- inspecting all blood facilities at least every two years
- inspecting “problem” facilities more often
- monitoring reports of errors and adverse events associated with blood donation or transfusion
- taking regulatory or legal actions if problems are found.
FDA’s blood safety efforts focus on minimizing the risk of transmitting infectious diseases, while maintaining an adequate supply of blood for the nation.
Blood safety is based on five layers of overlapping safeguards:
1. Donor screening. Donors are provided with educational material and asked to self-defer if they have risk factors that may affect blood safety. Donors are then asked specific questions about their medical history and other risk factors that may affect the safety of their donation. This “up-front” screening identifies ineligible donors.
2. 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 collection or use of blood from deferred donors.
3. Blood testing. After donation, blood establishments are required to test each unit of donated blood for the following transfusion-transmitted infections:
- 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
- West Nile Virus
- Trypanosoma cruzi (Chagas disease)
- And most recently, Zika virus
4. Quarantine. Donated blood must be quarantined until it is tested and shown to be free of infectious agents.
5. Problems and deficiencies. Blood establishments 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 may be subject to recall.
Emerging threats to the blood supply and other potential risks mean FDA’s Blood Safety Team never stops looking for ways to ensure and preserve the safety of blood and blood products.
FDA scientists are working to develop sensitive donor screening tests to detect emerging diseases and potential bioterrorism agents in blood donations. They are also working to improve blood donor screening tests to detect variant strains of HIV, West Nile virus and hepatitis viruses. In addition, FDA’s Office of Blood Research and Review addresses donor deferral issues and updates eligibility requirements when appropriate.
Also, FDA is a member of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism that includes other blood organizations, government agencies, and device manufacturers. As such, it works with others to help assure that blood facilities maintain adequate blood inventories at all times in case of a disaster.
Blood is critically needed every day, yet only a small percentage of the eligible United States 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 assessment that includes measuring vital signs and hemoglobin levels
- donating the blood (This takes about 15 to 20 minutes.)
- having a light refreshment to boost your energy level before leaving the facility.
To meet the basic requirements for donating blood, you must be in good health and
- have a pulse and blood pressure within normal limits
- have a normal temperature
- meet the minimum age requirement per applicable state law
- have a normal blood hemoglobin level
- be free of infections that can be transmitted through blood transfusion, or risk factors closely associated with exposure to these infections
- not have donated blood in the last 56 days
There are a number of potential reasons which may cause you to be temporarily or permanently deferred from donating blood. These include but are not limited to:
- not feeling well on the day of donation
- 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 in the past 12 months.
- getting tattooed in the last year (unless done under sterile conditions and at a state-licensed facility)
- having certain medical conditions or receiving certain medical treatments or medications
- living in or travelling to certain areas for a designated period of time; for example, travelling to an area where malaria is endemic
This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: October 7, 2016
Published: August 24, 2007
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