Every day, hospitals throughout the U.S. transfuse blood or blood components, such as platelets, to save the lives of people who are in car crashes, and victims of fires and other emergencies.
Blood is also needed for many people with life-threatening illnesses and others undergoing routine surgeries. According to the Centers for Disease Control and Prevention, blood centers and hospitals in the U.S. collect and transfuse millions of units of blood each year.
In fact, every two seconds, someone in the U.S. needs a blood transfusion. 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.
- People during and following labor and delivery.
- Premature babies.
- Trauma victims.
The U.S. Food and Drug Administration, through the Center for Biologics Evaluation and Research (CBER), is responsible for ensuring the safety of the more than the approximately 11 million units of whole blood donated each year in the U.S. These donations can be further processed into blood components, such as red blood cells, platelets and plasma.
In addition, about 4 million units of platelets and plasma intended for transfusion are collected annually by apheresis. Each year, there are more than 40 million collections of source plasma intended for further manufacturing use in life-saving products, such as immune globulins and albumin.
The FDA’s regulations and guidance regarding blood donor eligibility and donation testing protect the health of both the donor and the blood product recipient.
FDA oversight of the blood industry includes:
- Reviewing biologics license applications for blood products.
- Reviewing applications for devices used for blood collection, infectious disease testing and pathogen reduction technologies.
- Developing and enforcing regulations.
- Providing guidance on blood donor eligibility and donation testing, including responding to emerging infectious diseases.
- Inspecting blood manufacturing facilities.
- Monitoring reports of manufacturing deviations and adverse events associated with blood donation or transfusion.
- Taking regulatory actions if problems are found.
Five Layers of Safety
The 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. Prospective 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 risk factors that may affect the safety of their donation. This screening identifies individuals not eligible to donate.
2. Donor deferral lists. Blood establishments must keep current a list of deferred donors. They must also check all presenting donors against that list to prevent the collection of blood from deferred donors.
3. Blood donation testing. After donation, blood establishments are required to test each unit of donated blood for relevant transfusion-transmitted infections or, for certain infections, implement pathogen reduction technology, when appropriate. These relevant transfusion-transmitted infections include:
- Hepatitis B virus.
- Hepatitis C virus.
- Human immunodeficiency virus (HIV), types 1 and 2.
- Human T-cell lymphotropic virus (HTLV), types I and II.
- Treponema pallidum (syphilis).
- West Nile virus.
- Babesiosis (Babesia).
- Trypanosoma cruzi (Chagas disease).
4. Quarantine. Donated blood must be quarantined until it is tested and shown to be free of relevant transfusion-transmitted infections.
5. Problems and deficiencies. Blood establishments must investigate manufacturing problems, correct all deficiencies, and notify the FDA when product deviations occur in distributed products.
Ongoing Safety Efforts
Emerging threats to the blood supply and other potential risks mean the FDA never stops looking for ways to ensure the safety of blood and blood products.
FDA scientists are working to develop sensitive donation screening tests to detect emerging diseases or variant strains of known viruses, such as HIV. FDA laboratories study pathogen reduction technologies to further advance the safety of blood components for transfusion. The FDA’s Office of Blood Research and Review addresses and updates eligibility requirements and recommendations when appropriate.
The FDA is also a member of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism, which includes representatives from blood organizations, other government agencies, and device manufacturers. As such, it works with others to help assure that blood facilities always maintain adequate blood inventories 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. It includes:
- Registering at the donation site.
- Answering questions about your health and travel history.
- Getting a limited physical assessment, which 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.
Am I Eligible to Donate Blood?
To meet the basic requirements for donating blood, you must be in good health and:
- Have a pulse and blood pressure within acceptable limits.
- Have a normal temperature.
- Meet the minimum age requirement per applicable state law.
- Have an acceptable blood hemoglobin level.
- Be free of infections that can be transmitted through blood transfusion, or risk factors closely associated with exposure to such infections.
- Not have donated blood in the last eight weeks.
There are several potential reasons that 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.
- A history of nonprescription injection drug use.
- Getting tattooed in the last three months (unless done under sterile conditions and at a state-licensed facility).
- Having certain medical conditions or receiving certain medical treatments or medications.
- A history of residence or travel to areas endemic for certain transfusion transmitted infections. for example, travelling to an area where malaria is endemic.
The FDA’s recommendations for blood establishments are available at Blood Guidances.