Progress in Blood Supply Safety

by Monica Revelle

The blood supply plays a vital role in the American health system. Each year, Americans donate approximately 12 million units of blood, which are processed into 20 million blood products. About 3.6 million Americans receive transfusions of these blood products each year. Although the blood industry is ultimately responsible for the safety of the blood supply, the Food and Drug Administration is responsible for regulating the blood industry.

"Blood banking has become a manufacturing industry--an industry that must conform to high standards and quality control requirements comparable to those of pharmaceutical companies or other regulated industries," said David A. Kessler, M.D., FDA commissioner.

The technology of blood banking grew slowly in the early years of this century, then was markedly stimulated by the needs of World War II. On May 3, 1946, the Public Health Service issued the first federal license allowing an establishment to manufacture whole blood.

In the United States today, licensed establishments include more than 1,000 donor centers that collect, process and distribute blood and blood products in interstate commerce under federal regulations. Establishments not involved in interstate commerce are not licensed, but they register with and, like licensed establishments, are inspected by FDA and are subject to the same high standards as licensed establishments.

The United States has the safest blood supply in the world, and FDA is striving to keep it safe by decreasing the risk of infectious disease transmission. The agency is continuously updating its requirements and standards for collecting and processing blood. The Blood Products Advisory Committee, a group of outside experts, provides a broad perspective and state-of- the-art experience to issues confronting FDA, so that the agency's final decision will reflect a balanced evaluation. Although FDA is not bound to follow the advisory committee's recommendations, it usually does.

Ongoing improvements and refinements together with advances in technology and science promise more sophisticated methods of blood collection and more accurate tests to protect the blood supply.

Nonetheless, blood and blood products are not entirely risk-free. There is a remote risk of infection with serious blood-borne viruses such as hepatitis and HIV, the virus that causes AIDS. But for patients who need blood transfusions, the risk of transfusion-associated disease is far less than the risk of dying or becoming more seriously ill without a transfusion. (See "Alternatives to Regular Blood Transfusion" in the July-
August 1994 FDA Consumer.)

How FDA Regulates the Blood Industry

As technology develops and new information about the transmission of infectious diseases becomes available, FDA's Center for Biologics Evaluation and Research issues written guidance to all blood establishments. This guidance sets the standard for the industry and is incorporated into standard operating procedures for all blood facilities.

FDA's guidance generally has also been supported and adopted by blood establishments and all major blood organizations, including the American Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers, the American Blood Resources Association, and others involved in collecting and distributing blood and blood products.

FDA investigators in district offices across the country conduct inspections of all licensed blood establishments each year. Inspections are conducted every other year for those establishments that consistently comply with the agency's standards and regulations. These inspections insure that the blood establishments are adhering to all the proper procedures and regulations. During the inspection, investigators monitor donor screening; blood testing, labeling, storage, and handling; and record keeping and other manufacturing practices. FDA expects the establishment to promptly correct any problems or deficiencies. Furthermore, the investigators may verify resolution of deficiencies through follow-up inspections.

FDA can order a recall of hazardous blood products, issue warning letters, seize products, suspend or revoke the establishment's license, or take other legal actions that can result in civil or criminal penalties against the establishment and its officials.

For example, after repeated failures to comply with federal standards, one blood bank signed a consent decree enjoining it from further collection and manufacturing. The establishment closed in November 1993 until FDA could determine that the infractions--including some that created potential disease transmission hazards--had been corrected. (See "North Carolina Blood Bank Closed" in the Investigators' Reports section of the July-August 1994 FDA Consumer.)

FDA has taken action in other cases involving centers in a number of states. These actions include suspending licenses and taking steps to revoke licenses of establishments not complying with regulations and standards to safeguard the blood supply. The agency has also requested recalls of blood, when necessary.

At press time, in all cases, the facilities had taken corrective action to bring firms into compliance with FDA regulations.

Layers of Safeguards

The heart of the blood safety system established by FDA is five layers of overlapping safeguards that start at the blood collection center and extend to the manufacturers and distributors of blood products.

• Donor screening. Potential donors must answer questions about their health and risk factors. Those whose blood may pose a health hazard are encouraged to exclude themselves. A trained and competent health professional then interviews potential donors regarding their medical history.

Donors can be temporarily deferred (excluded from donating blood) for a number of reasons, including having a temperature, cold, cough, or sore throat on the day of donation or taking certain medications, such as Accutane (isotretinoin) or Proscar (finasteride). Reasons potential donors are permanently excluded from donating blood include evidence of HIV infection, male homosexual activity since 1977, a history of intravenous drug abuse, or a history of viral hepatitis.

• Blood testing. After donation, the blood is tested for such blood-borne agents as HIV, hepatitis and syphilis. (See accompanying article.)
• Donor lists. Blood establishments must keep current a list of deferred donors and check donor names against that list.
• Quarantine of untested blood. Blood products are not available for general use until the products have been thoroughly tested.
• Investigation of problems. Blood establishments must investigate any breaches of safeguards and correct deficiencies. Licensed firms must report to FDA any manufacturing problems, errors or accidents that may affect the safety, purity or potency of their products. Registered firms, although not required to report problems, are required to thoroughly investigate problems and maintain accurate records for FDA to review during an annual inspection.

An error or accident can result from improper testing, incorrectly labeled components,improper interpretation of test results, improper use of equipment or failure to follow the manufacturers' directions for its use, or accepting units from donors who should have been deferred.

In addition, products such as immune globulin and clotting factors must be treated to inactivate any virus that may be present with processes such as treatment with heat, solvent or detergent. FDA is committed to holding all blood centers to the highest standards, said Kessler. When it comes to these vital products, our standards can never be too high.

Because of the potential risks involved, FDA regards blood or blood components unsuitable for use if any safeguard is breached. Unsuitable units are subject to recall because of the potential risk, even if tests do not show definitively that the products are contaminated. Because of the safeguards in the system, recalled blood products generally present only a remote health risk.

Improved Standards

FDA monitors all phases of blood preparation and manufacture. In recent years, the agency has intensified its oversight of blood establishments and taken measures to strengthen standards.

The agency has issued a proposed quality assurance guideline to help blood establishments recognize and prevent recurring problems. The guideline emphasizes that manufacturers of blood and blood components should have written quality assurance programs that will help eliminate the causes of errors, ensure the integrity of test results, implement effective controls for manufacturing processes and record-keeping systems, and ensure adequate employee training. Competency evaluations, equipment validation, and laboratory testing procedures, as well as self- policing audits are designed to prevent accidents and errors that can result in the release of unsuitable blood products.

In addition, under this proposed regulation all licensed and registered blood establishments would have to implement "look back" procedures already followed at most facilities. Under these procedures, blood establishments retrieve and quarantine units previously collected from a donor who at the time of donation tested negative for HIV, but subsequently tested positive. The blood establishment then does more specific tests on a current sample of the donor's blood. If the results are positive, previously donated units cannot be used in transfusions, and people who received such units must be notified.

Another measure to strengthen blood safety is FDA's decision to regulate blood establishment computer software as medical devices. Blood establishments use such software in managing donor registries, testing blood, and storing records and other data. Software also helps identify unsuitable donors and prevents the release of unsuitable blood and blood components.

Recognizing the critical role of software in blood establishment operations, FDA has notified manufacturers of computer software for blood establishments that it considers these products to be devices covered under the Federal Food, Drug, and Cosmetic Act when they are intended for use in the manufacture of blood products. The manufacturers now must register with FDA, list all the products they make, provide FDA premarket notification or submit the product for approval, comply with current good manufacturing practice regulations, and report adverse events.

FDA also notified these manufacturers that it will continue to inspect their establishments. The primary focus of these inspections will be to assess compliance with the good manufacturing practices, including a review of the standards for software development, testing, validation, and quality assurance. FDA will also review and assess manufacturers' procedures for investigating product complaints, including their procedures for correcting problems and for notifying customers and FDA when corrective actions are taken.

As the blood industry has become more complex, FDA's oversight has become more comprehensive and attentive to all aspects of the blood industry. These steps are intended to make the blood supply as safe as possible so that patients can continue with confidence to take advantage of its lifesaving potential.

Monica Revelle is an FDA press officer.

A reprint from FDA Consumer Magazine

Printed May 1995

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration

We hope you found this reprint from FDA Consumer magazine useful and informative. FDA Consumer, the magazine of the U.S. Food and Drug Administration, provides a wealth of information on FDA-related health issues: food safety, nutrition, drugs, medical devices, cosmetics, radiation protection, vaccines, blood products, and veterinary medicine. For a sample copy of FDA Consumer and a subscription order form, write to: Food and Drug Administration, HFI-40, Rockville, MD 20857.

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