Vaccines, Blood & Biologics
Blood Donor Screening
Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products. Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors. FDA also requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them. Also, blood donations are now tested for seven different infectious agents. In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry. The agency inspects all blood facilities at least every two years, and "problem" facilities are inspected more often. Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.