How FDA Safeguards the Blood Supply

Article excerpt

Widespread concerns have developed about the safety of the blood supply since the advent of the AIDS epidemic. But a close look reveals that enormous progress has been made in preventing the transmission of infectious agents though blood products. In fact, FDA and the blood industry have implemented safeguards in recent years that have made the blood supply much safer than ever before.

Blood is vital to the American healthcare system, and FDA plays a crucial role in ensuring the safety of the nation's supply. Every year, more than 11 million units of blood are drawn from volunteer donors for use in more than 3.5 million Americans. Much of this blood is further processed to manufacture specialized therapeutic agents such as immune globulin to prevent infections and clotting factors used to treat hemophilia.

The Public Health Service, of which FDA is a part, has been responsible for regulating the blood supply ever since the modern blood-banking industry was developed in the 1940s. Under the Public Health Service Act and other laws, FDA's Center for Biologics Evaluation and Research has the authority to license all blood establishments that participate in interstate commerce and to inspect the more than 2,500 registered blood establishments throughout the United States that process blood. FDA establishes regulations and guidelines designed to protect the blood supply from dangerous contaminants and unsafe practices and uses its ongoing inspection program to insure the blood industry's full compliance with good manufacturing practices.

Safety Starts with Donation

Blood safety begins with the donation. Only healthy individuals are allowed to give blood. All potential donors undergo extensive screening designed to reveal any medical condition or behavioral pattern that may put them at greater risk of carrying a blood-borne infectious agent. If information from the screening procedures indicates that a donor has a high risk of having been exposed to the AIDS virus or to other dangerous viruses or bacteria (such as those that cause hepatitis or syphilis), that person is not permitted to donate blood.

Blood banks must inform all potential donors about risk factors for these diseases in writing and through direct questioning. Potential donors who are concerned that they may be at risk for infectious conditions but are reluctant to acknowledge their risk status to blood bank personnel are also given opportunities to indicate, anonymously, that their blood should not be used for transfusion. This confidential exclusion is accomplished a number of different ways, including the use of cards with bar codes that correspond to an individual's donated unit.

Contrary to popular belief, the practice of paying people to donate blood for transfusion rarely, if ever, occurs in the United States. This practice virtually ended nearly 20 years ago. Today blood collection for transfusion use is voluntary, and donors have no financial incentive to give their blood.

The situation with the collection of plasma for use in manufacture is somewhat different. Plasma--the clear, yellowish, fluid portion of blood--can be collected more often than whole blood because the remaining elements of the blood, such as the red cells and platelets, can be reinfused into the donor at the time of donation. To encourage the greater rate of donation needed to keep pace with the demand for plasma-derived products, plasma centers usually pay their donors. However, plasma collection facilities must follow many of the screening and testing procedures required by FDA, including thorough physical examinations of all donors on a regular basis.

Moreover, unlike blood for transfusion, plasma products must be processed to refine them for therapeutic use. This processing includes treatments that kill or eliminate viruses.

As Gerald V. Quinnan, M.D., acting director of the Center for Biologics Evaluation and Research, notes, "The manufacturing processes for plasma derivatives are varied. …