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Blood Plasma Safety: Plasma Product Risks and Manufacturers' Compliance

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Report Type Reports and Testimonies
Report Date Sept. 9, 1998
Report No. T-HEHS-98-242
Subject
Summary:

Limiting the number of donors whose plasma is pooled for production into plasma products helps to lower the risk of viral transmission. More significantly, viral clearance techniques have made the risk of receiving an infected blood plasma product extremely low when manufacturers follow procedures to ensure safety. Viral removal and inactivation procedures can virtually eliminate enveloped viruses, such as those responsible for AIDS, hepatitis B, and hepatitis C. However, recent Food and Drug Administration (FDA) inspection reports have cited many instances of noncompliance with good manufacturing practices, which could pose a risk for those who rely on plasma products. These problems have led to the imposition of consent decrees between FDA and two manufacturers, the temporary suspension of production at one manufacturing plant, and shortages of some plasma products. This testimony summarizes the September 1998 report, GAO/HEHS-98-205.

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