Blood Plasma Safety

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. GAO summarized this report in testimony before Congress; see: Blood Plasma Safety: Plasma Product Risks and Manufacturers' Compliance, by Bernice Steinhardt, Director of Health Services Quality and Public Health Issues, before the Subcommittee on Human Resources, House Committee on Government Reform and Oversight. GAO/T-HEHS-98-242, Sept. 9 (10 pages).

GAO noted that: (1) viral clearance techniques have made the risks of receiving an infected plasma product extremely low when manufacturers follow all the procedures in place to ensure safety; (2) while paid plasma donors are over one and a half times more likely to donate potentially infectious units (1 in every 3,834 units), a number of recent initiatives by the source plasma industry greatly reduce the chances of these units being pooled for manufacturing (to 1 in every 10,959 units); (3) even with these initiatives in place, the risks are still somewhat higher from plasma units donated by paid donors than from volunteer donors; (4) limiting the number of donors whose plasma is pooled for production into plasma products helps to reduce the risks of viral transmission for those receiving these products; (5) presently, a 60,000-donor limit has been established for each individual plasma product; (6) this effort has an impact on infrequent users by minimizing their exposure to a certain number of donors for the few times they would be infused with a plasma product; (7) for frequent users of plasma products, this donor limit has a negligible impact because of the large number of infusions that they receive and, thus, the large number of pools that they would be exposed to in the course of their lifetime; (8) a more significant step in reducing risk of infection occurs in manufacturing--where all plasma products for intravenous use undergo viral removal, inactivation procedures, or both--which virtually eliminates enveloped viruses such as HIV, HBV, and HCV; (9) this is supported by epidemiological data on the transmission of viruses through plasma products since the introduction of adequate viral removal and inactivation procedures in the late 1980s as well as laboratory data that characterize the effectiveness of viral clearance through these procedures; (10) certain advances are only effective if the processes used to produce finished plasma products adhere to current good manufacturing practices; (11) this, however, has not been the case with all of the major manufacturing companies that produce plasma products; and (12) without strict adherence to current good manufacturing practices related to the efficacy of viral removal and inactivation procedures, the safety of these plasma products could be compromised.