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The FDA and Blood Safety

The safety of the blood supply in the United States is monitored and guaranteed by the FDA. Safeguards instituted by the FDA are designed to protect blood donors, recipients and patients from contaminated or unsafe blood and blood products, medical errors and faulty medical devices. The goal is to maintain the safest blood supply possible with the lowest risk of disease transmission.

  1. Center for Biologics Evaluation and Research

    • The Center for Biologics Evaluation and Research (CBER) is an agency inside the FDA who acts under federal law to regulate blood and other biological products. The goal of CBER is monitor the safety of all biologics, including blood, to protect the health of the public. Some medical devices are monitored by this agency, including those used in blood bank collection.

    Blood Products Advisory Committee

    • An outside agency responsible for advising the FDA commissioner, the Blood Products Advisory Committee (BPAC) evaluates the safety of blood and blood products, such as serum and plasma, designed for medical use. They also review the safety of medical devices being used in the healthcare field. The FDA takes actions based on the recommendations made by BPAC and may approve or revoke a health facilities license, institute improvements and conduct research studies.

    Blood Donation

    • According to the American Red Cross and National Blood Data Resource Center, over 8 million people donated blood in 2001 resulting in the collection of approximately 15 million units of blood. A defined system of donor information, screening, handling, distribution and usage of blood has been established by the FDA to prevent the transmission of infection to recipients. These regulations are also designed to reduce the risk or harm or potentially fatal reaction from the receipt of improperly cross-matched blood.

    Blood Bank Safety

    • Preventing and reducing the risk of infection associated with blood donation is one of the primary goals of the FDA. Prior to the donation process at a blood bank collection center or hospital, donors are asked questions to identify risk factors and potential infection. Up to 90 percent of high risk donors are excluded from donation due to the screening. Medical devices such as needles and collection bags are used one time and medical devices properly disposed of. After the collection process is completed, blood donations are screened to identify diseases able to cause infection in recipients.

    Healthcare Industry

    • Any healthcare facility and laboratory responsible for handling blood and blood products is inspected by the FDA at a minimum of every two years or more depending on the results of the evaluation. Institutions identified as problematic or high risk are inspected with increased frequency until the issues are corrected to protect both healthcare workers and patients.

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