Blood Plasma Safety:

Plasma Product Risks and Manufacturers' Compliance

T-HEHS-98-242: Published: Sep 9, 1998. Publicly Released: Sep 9, 1998.

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GAO provided information on blood plasma safety, focusing on: (1) comparing the risks of incorporating infected plasma from donations from volunteer donors with those from paid donors into the manufacturing process; (2) the impact on frequent and infrequent plasma users when pooling large numbers of plasma donations into manufactured plasma products; (3) the safety of end products from plasma after they have undergone further manufacturing and inactivation steps to kill or remove viruses; and (4) the recent regulatory compliance history of plasma manufacturers.

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) although paid plasma donors are over one and a half times more likely to donate potentially infectious units, several initiatives by the paid plasma industry have greatly reduced the chances of these units being included in the plasma production pool; (3) these initiatives include using only repeat donors and a 60-day inventory hold on all units to allow manufacturers to retrieve units from donors who subsequently test positive for disease or are otherwise disqualified; (4) even with those initiatives in place, plasma donated by paid donors poses a higher risk of infection; (5) limiting the number of donors whose plasma is pooled for production into plasma products helps to reduce the risks of viral transmission for recipients of these products; (6) a more significant step in reducing risk of infection takes place in manufacturing, during which all plasma products undergo viral removal or inactivation procedures, which virtually eliminate enveloped viruses; (7) epidemiological and laboratory data on the transmission of viruses through plasma products since the introduction of viral removal and inactivation procedures support the value of these procedures; (8) the effectiveness of these processes is limited, however, in reducing transmission of nonlipid enveloped viruses; (9) voluntary initiatives by the commercial plasma industry, technological advances from increasingly sophisticated screening tests, and viral removal and inactivation procedures are only effective if manufacturers of finished plasma products adhere to current good manufacturing practices; (10) not all of the major manufacturing companies producing plasma products adhere to these practices; (11) recent Food and Drug Administration (FDA) inspection reports highlight many instances of noncompliance with current good manufacturing practices; (12) this has led to consent decrees between FDA and two companies, temporary suspensions of production at one company's facility, and shortages of some plasma products; (13) a lack of strict adherence to these practices related to viral removal and inactivation procedures could compromise the safety of plasma products; and (14) actions being taken by FDA and the plasma manufacturers since these problems were identified should help to alleviate some of these problems.

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