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The Food and Drug Administration's perspective on plasma safety
W K Hoots1, C Abrams, D Tankersley
1Houston Health Science Center and the MD Anderson Cancer Center, University of Texas, Houston, TX 77030, USA.
Transfusion Medicine Reviews
|July 7, 2001
Summary
Ensuring plasma product safety involves a triple net: donor selection, testing, and inventory holds. Advances like PCR testing improve safety but raise cost and donor impact dilemmas.
Area of Science:
- Biotechnology
- Immunology
- Public Health
Background:
- Plasma products carry a minimal risk of infectious disease transmission.
- The Food and Drug Administration (FDA) employs a triple safety net to ensure plasma product safety.
Purpose of the Study:
- To review the components of the FDA's plasma product safety net.
- To discuss improvements and dilemmas associated with plasma product safety measures.
Main Methods:
- Review of donor selection criteria.
- Analysis of plasma testing methodologies, including antibody and PCR (polymerase chain reaction) testing.
- Evaluation of inventory hold procedures (look back and retrieval).
Main Results:
- Each safety net component (donor selection, testing, inventory hold) contributes to reducing viral load but has limitations.
- Advances in antibody testing and the addition of PCR testing have enhanced safety.
- Inventory hold, particularly for new donors, significantly bolsters product safety.
Conclusions:
- While current safety measures are effective, ongoing advancements like PCR testing present new challenges.
- Dilemmas include balancing zero-risk goals with costs and managing donor impact from positive test results.
- The integration of new testing technologies and their role in plasma-pool and final-product testing require careful consideration.