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1 Introduction
Pages 19-24

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From page 19...
... The safety of the blood supply is a shared responsibility of many organizations-the plasma fractionation industry, community blood banks, the federal government, and others. Public concern about the inherent risks of blood and blood products has led the federal government, through the agencies of the Public Health Service, to take the lead in ensuring blood safety.
From page 20...
... There were also many changes occurring in the government and society, such as a presidential mandate to lessen the regulatory role of government and increased public awareness that the homosexual population was enduring stigmatization and discrimination (Bayer 19831. As evidence for blood-borne transmission of AIDS accumulated in 1982 and 1983, the Public Health Service had to deal with a very difficult problem.
From page 21...
... Mathematical projections from reported transfusion-associated AIDS cases estimate that approximately 12,000 people now [1987] living in the United States acquired a transfusion-associated HIV infection between 1978 and 1984 [CDC, MMWR, 1987a]
From page 22...
... These hypotheses take account of the legal authority of relevant organizations; the information available to them; the countervailing public health considerations and scientific knowledge that influenced particular decisions; the resource limitations that constrained organizations; the institutional, social, and cultural obstacles; the public or private interest motivations of organizations; and the economic and political incentives that influenced decisions.
From page 23...
... The Office of the Assistant Secretary of DHHS identified sources of information within the federal service; and others representing nongovernment agencies made themselves known to the IOM Committee and staff. Among the topics for literature searches were: history of hemophilia; history of blood collection activities; scientific knowledge about HIV; viral inactivation processes; hepatitis; risk communication; social and ethical implications of AIDS; and regulations concerning blood products.
From page 24...
... Chapter 5 addresses strategies for protecting the safety of the blood supply by screening potential donors, examining closely the factors that influenced decisions regarding the implementation of donor screening measures. Chapter 6 examines the role of the FDA in regulating blood and blood product safety, highlighting several critical events, such as the FDA's guidance for implementing donor screening practices, recall of potentially contaminated products, and procedures to inform recipients of contaminated products.


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