01/27/2023 | Press release | Distributed by Public on 01/27/2023 13:47
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), 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 America needs blood, according to the American Red Cross (ARC). This may include:
Blood products from healthy donors are often lifesaving or life enhancing.
The FDA, through the Center for Biologics 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 United States. These donations can be further processed into blood components such as Red Blood Cells, platelets, and plasma. In addition, approximately 4 million units of platelets and plasma intended for transfusion are collected annually by apheresis. FDA's regulations and guidance regarding blood donor eligibility, blood donation and processing help protect the health of both the donor and the recipient.
FDA oversight of the blood industry includes:
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 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 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:
4. Quarantine. Donated blood must be quarantined until it is tested and shown to be free of transfusion-transmitted infections.
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 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 and updates eligibility requirements and recommendations when appropriate.
Also, FDA is a member of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism that includes representatives from blood organizations, other 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:
To meet the basic requirements for donating blood, you must be in good health and
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: