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  1. Safety & Availability (Biologics)

Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood

Keeping the United States blood supply the world's safest is the ultimate responsibility of the nation's blood establishments that collect and process the units of whole blood donated by volunteers each year. The Food and Drug Administration, however, has the vital role of ensuring that patients who receive a blood transfusion are protected by multiple overlapping safeguards. This FDA blood-safety system includes measures in the following areas:

  • Donor screening
  • Blood testing
  • Donor deferral lists
  • Quarantine
  • Problems and Deficiencies

Donor screening: Donor screening plays an important role in ensuring the safety of the U.S. blood supply. FDA regulations require that a donor be free from any disease transmissible by blood transfusion, in so far as can be determined by health history and examination.

Donors are informed about potential risks and are required to answer questions about factors that may have a bearing on the safety of their blood. For example, donors with a history of intravenous drug abuse are routinely deferred.

In addition to federal regulations, FDA periodically issues guidance documents providing recommendations to decrease the potential for transmission of infectious diseases when new information or testing methodologies becomes available. For example, since November 1999, the FDA has recommended that the blood industry defer potential donors who have lived in the United Kingdom and other European countries to reduce the risk of variant Creutzfeldt-Jakob disease (vCJD), the human form of "mad cow disease."

Blood testing: The FDA reviews and approves all test kits used to detect infectious diseases in donated blood. After donation, each unit of donated blood is required to undergo a series of tests for infectious diseases, including:

Hepatitis B and C viruses

Human Immunodeficiency Virus, Types 1 and 2

Human T-Lymphotropic Virus, Types I and II

Treponema pallidum (Syphilis)

Additionally, FDA recommends testing for the following infectious diseases:

West Nile Virus

Trypanosoma cruzi (Chagas disease)

Donor deferral lists: Blood establishments must keep current a list of deferred donors and use it to make sure that they do not collect blood from anyone on the list.

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 the FDA when product deviations occur in distributed products.

If any one of these safeguards is breached, the blood component is considered unsuitable for transfusion and is subject to recall.

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