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| Progress in Blood Supply Safety
*by Monica Revelle* |
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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. 

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

| Testing Blood                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
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| One of the cornerstones of maintaining a safe blood        supply is testing. FDA requires that all blood establishments test each        unit of blood for a variety of blood-borne diseases. Furthermore, FDA        reviews and approves all assay test kits used to detect infectious and        transmittable diseases in donated blood. Each unit of blood must be        tested for: - hepatitis B, using hBsAg ( an indicator of the virus) and hB core            antibody (an indicator of the antibody) tests 
- hepatitis C, using a hepatitis C antibody test 
- HIV-1 (AIDS virus), using an HIV-1 antibody test | - HIV-2 (also causes AIDS, but it is far less prevalent in the            United States than HIV-1), using an HIV-2 antibody test 
- HTLV-1 for evidence of a rare leukemia virus found mainly outside            the United States 
- syphilis for evidence of this sexually transmitted disease. 
In the early 1970s, the risk of contracting some form of hepatitis        from a unit of blood was as high as 6 to 8 percent. Now the risk of        contracting hepatitis B per unit of blood is approximately 1 in 250,000,        and the risk for contracting hepatitis C is less than 1 in 3,300. | For HIV, the virus that causes AIDS, the risk of        infection has decreased from 1 in 2,500 in 1985 to around 1 in 225,000        today. In 1985, FDA licensed the first test, HIV-1 enzyme        immunoassay, capable of detecting HIV antibodies in blood. In 1987, the        agency licensed the more precise Western Blot Test, which is used as a        confirmatory test. Screening tests are continually being improved. The        test for hepatitis C detects the antibody in about 90 percent of chronic        non-A, non-B hepatitis cases. However, more sensitive tests are being        developed. The screening test for HIV is among the most sensitive,        detecting evidence of infection in more than 99 percent of infectious        samples. |

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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