HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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2 The U.S. Blood Supply System
2 The U.S. Blood Supply System
Pages 25-56
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From page 25... ...
Finally, this chapter also presents information on the federal agencies responsible for blood safety, the history of blood and blood product regulations, and the regulatory authority of the FDA. BLOOD AND BLOOD PRODUCTS There are two different types of blood collection activities.
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From page 26... ...
, and education Advocacy for plasma fractionation industry, education
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As shown in Table 2.2, among the components prepared from whole blood are red blood cells, platelets, fresh frozen plasma, and cryoprecipitate. Blood banks make many modifications of these components to obtain blood products that will be effective for specific purposes.
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From page 29... ...
. Plasma that is a by-product from whole blood collected by community blood banks or hospitals is sold to commercial companies in the plasma fractionation industry, who in turn manufacture the plasma derivatives and sell them in the
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From page 30... ...
Up to the early 1980s, plasma collection centers could be located in prisons and other areas where there was a high prevalence of hepatitis and other chronic infections. With the possible emergence of AIDS in the blood supply, plasma fractionators began closing their prison collection sites in December 1982, and in essence all were closed by January 1984.
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From page 31... ...
Much of the plasma obtained from whole blood collected by blood banks is also used for production. Blakestone has estimated that in 1990 approximately 12 million liters of plasma were consumed in the manufacture of plasma derivatives (Blakestone 19941.
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From page 32... ...
. pernicious anemia Passive immunization subsequent to exposure to hepatitis B Treatment and prevention of septicemia and septic shock due to toxin liberation in the course of antibiotic treatment Treatment of agamma- and hypogamma-globulinemia; passive immunization for hepatitis A and measles
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From page 33... ...
:immune globulin Rubella immune globulin Serum-cholinsterase Tetanus immune globulin Vacc~nia immune globulin Varicella-zoster immune globulin Restoration of plasma volume subsequent to shock, trauma, surgery, and burns Passive immunization subsequent to exposure to rabies Treatment and prevention of hemolytic disease of fetus and newborn resulting from Rh incompatibility and incompatible blood transfusions Passive immunization subsequent to exposure to German measles Treatment of prolonged apnea after administration of succinylcholine chloride Passive immunization subsequent to exposure to tetanus Passive immunization subsequent to exposure to smallpox Passive immunization subsequent to exposure to chicken pox _ Blood and Blood Components Distribution Traditionally, some areas of the United States have been able to collect more blood than needed locally and have provided these extra units to other communities. The misalignment of blood use and blood collection is a longstanding phenomenon.
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From page 34... ...
BLOOD COLLECTION ORGANIZATIONS The United States blood collection system is heterogeneous owing to the `' random development of blood centers without regard .
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From page 35... ...
by blood center and hospitals.: Blood centers are fixe=£=di3lg Olga virtually ~.1 of wash me wnp~Q0~* These centen :axe governed by a bond of local volunteer and are organizations whose~sole function is to provide the community's blood supply.
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, the Council of Community Blood Centers (CCBC) , and the American Blood Resources Association (ABRA)
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From page 37... ...
These efforts include group purchasing of supplies, services, and liability insurance; increasing volunteer blood donation; effective sharing of blood resources; strengthening of blood center management skills and the scope of services provided to the community; training programs to assure compliance with federal regulations; assuring fair and balanced resolution of disputes between blood centers and the public they serve; influencing federal and state regulations and policies; and promoting needed research and development in the blood services area. The CCBC also promotes information exchange between members of operational practices, new programs, policies, and ideas through surveys,
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From page 38... ...
American Blood Resources Association The American Blood Resources Association (ABRA) is a trade association founded in 1971 to represent the plasma collection and fractionation industry in both federal and state government relations.
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From page 39... ...
. On October 1, 1976, a total of $3 million was appropriated to fund more than 20 regional hemophilia treatment centers [Federal Register, 1976, 1977]
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Medical and Scientific Advisory Council One important national activity of the NHF is MASAC. In 1982, the primary mission of MASAC was to advocate for continued development and expansion of an accessible comprehensive care network, to advocate for quality treatment and care for hemophilia, to support and be involved in hemophilia research, to discuss timely issues of relevance to the hemophilia community and make recommendations concerning them, and to continue to provide technical information, educational materials, and publications.
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From page 41... ...
was established and funded by the National Heart, Lung, and Blood Institute and was charged with implementing the "lion's share" of the objectives set forth in the National Blood Policy (OTA 1985~. The progress of the ABC was hindered by lack of funds, disagreement between the two largest blood suppliers, resistance to regionalization of blood collection and distribution, problems in obtaining data from blood banks, and a lack of knowledge of blood banking by lay members of the commission (U.S.
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From page 42... ...
The federal system by which public health policy decisions are made comprises the Centers for Disease Control and Prevention, the agency that conducts surveillance and reporting of disease; the National Institutes of Health, the organization that conducts research; and the Food and Drug Administration, the regulatory arm of the PHS. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC)
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From page 43... ...
. In 1970, Congress amended the Biologics Act, which, as discussed later in this chapter, was originally enacted in 1902 to provide the framework for federal regulation of biological products for human use, to include vaccines, blood, blood components or derivatives, and allergenic products.
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From page 44... ...
The responsibilities of the Bureau of Biologics fell under this new center and the regulation for blood products and blood banking technologies was under the purview of the Office of Biologics Research and Review. The Office of Biologics in the Division of Blood and Blood Products was responsible for approval of license applications and amendments for new blood establishments and blood products, and for approval to market blood products and related technologies (OTA 1985~.
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From page 45... ...
In carrying out these functions, the CBER cooperates with other Public Health Service organizations, governmental and international agencies, volunteer health organizations, universities, individual scientists, nongovernmental laboratories, and manufacturers of biological products. Blood Products Advisory Committee The FDA makes extensive use of technical advisory committees in the support if its evaluation and regulation of drugs, biologics, and medical devices for human use.
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, which provides evaluation of data related to safety, effectiveness, and labeling of blood and blood products and makes appropriate recommendations to the Secretary, the Assistant Secretary for Health, and the FDA commissioner (IOM 19921. Advisory committee nominations include candidates from relevant professional and scientific bodies, medical schools, academia, government agencies, industry and trade associations, and consumer and patient organizations.
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Prior to 1970, the Biologics Act did not specifically include blood products. In 1970, Congress amended the Biologics Act
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Blood Shield Laws During the 1950s and 1960s, blood shield laws were adopted by 47 different jurisdictions. The blood shield laws were developed to exempt blood and blood products from strict liability or implied warranty claims on the basis that blood and blood products provide a service, not a sale.
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From page 49... ...
Over the years, this law has been specifically amended to include the terms blood and blood component or derivative to make it clear that blood and blood products are subject to the biologics regulation. Establishment Licensure and Registration Presently, there are 188 FDA-licensed organizations at 790 locations for collection and interstate shipment of blood and blood components.
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From page 50... ...
For the manufacture of plasma derivatives, the product license application involves the manufacturer's (organization's) name; the establishment name; procedures for determining donor suitability including medical history, examination by physician, laboratory testing, methods of preparing the venipuncture site, and collecting the plasma; methods to prevent circulatory embolism and to assure return of red cells to the proper donor; minimum intervals between donation and maximum frequency of donation; techniques for immunizing donors; laboratory tests of collected plasma; techniques of preparing source plasma and storing it; methods to ensure proper storage conditions and identification of units; label control systems; and shipping conditions and procedures.
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From page 51... ...
However, the FDA's enforcement cannot be by self-regudation, and the FDA's General Counsel determines if a violation of legislative mandates constitutes grounds for legal action (Huts and Merrill 1991) (See Chapter 6, which focuses on FDA's regulation of blood and blood products during the period 1982-1986 when HIV contaminated the blood supply and before the development of a test to detect antibody to HIV, for more information)
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From page 52... ...
(A less formal discussion of recall appears in Chapter 6 and focuses on FDA's regulation of blood and blood products during the period 1982-1985 when HIV contaminated the blood supply and before the antiviral HIV test was developed.) A recall is a method for removing or correcting marketed products that violate the laws am nistered by the FDA.
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From page 53... ...
The blood segment of the collection system is primarily not for profit, the plasma segment is primarily for profit. The federal government regulates blood banking, monitors the safety and efficacy of blood products, and promotes research on blood diseases.
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From page 54... ...
The Economics of Importing vs Collecting. In Adequacy of the Blood Supply, Council of Community Blood Centers conference proceedings; Clearwater, Florida.
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From page 55... ...
In Adequacy of the Blood Supply, Council of Community Blood Centers conference proceedings, Clearwater, Florida, February 18, 1990. Smith, Peter, and Levine, Peter.
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