Blood Plasma Regulations

Blood plasma is the fluid portion of circulating blood, according to the U.S. Department of Health and Human Services (HHS). In the United States, the donation of plasma and the overall safety of blood and blood products are regulated by the Food and Drug Administration (FDA) to ensure a safe blood supply and to minimize the risks associated with receiving blood and plasma.

The Facts

• The United States blood supply is one of the safest in the world. According to the American Red Cross, about three out of every 100 Americans donate blood products annually. More than 3 million Americans receive transfusions of whole blood each year, whereas plasma undergoes a manufacturing process for medical therapies. Plasma is collected in specialized donation centers across the country.

Regulation Process

• Blood plasma regulation begins with donor screening and eligibility. Everyone who donates plasma undergoes two medical exams and a complete medical history before becoming eligible to donate. After they donate, their blood and plasma are tested for transmissible viruses like HIV, syphilis and other blood-borne pathogens, according to HHS. Those not eligible to donate plasma are put on a list to be prevented from donating. All blood products, including plasma, are quarantined until the necessary tests are performed and donation records verified. All donation centers and blood establishments have to adhere to these safeguards and report breaches to the FDA.

Significance

• Plasma plays an important role in the human body. It contains proteins for blood clotting and defending the body against infection, according to DonatingPlasma.org. Plasma donation is a lifesaving act; people with rare and genetic diseases rely on plasma to replace the protein and antibodies they need to experience healthy lives. Plasma also contains albumin, which is used to restore plasma in treatment of shock. Regulation of blood and plasma is important to manage the risks and maintain the quality of the blood supply.

Risks

• Despite the U.S. having one of the world's safest blood supplies, there's always a risk involved with receiving blood and plasma products. Infectious diseases can be transmitted through blood and plasma. Collection centers employ professionally trained staff to minimize the risks and all container or transfer equipment that comes in contact with blood and plasma is used just once to prevent disease transmission.

Expert Insight

• Many plasma donation centers choose to enroll in the International Quality Plasma Program (IQPP), which helps to further improve the quality and safety of blood plasma. IQPP provides additional standards for donor and center management. The Plasma Protein Therapeutics Association, which initiated IQPP, also establishes standards for the plasma-manufacturing process for medical therapies.