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Blood donations go through five layers of safety
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The FDA is responsible for ensuring the safety, purity and potency of blood products, which are subject to biologics and drug regulatory oversight, according to a webinar given by Richard J. Davey, MD, director of the division of blood applications, Office of Blood Research and Review, at the FDA’s Center for Biologics Evaluation and Review.
“Blood is highly regulated, not just by the FDA, but also by state regulation. In addition, there is oversight by the CDC, the Occupational Safety and Health Administration and the American Association of Blood Banks,” Davey said.
About 40% to 45% of people in the United States are eligible to donate blood, but only 2.5% to 4.5% actually donate, he said. This leads to periodic shortages and appeals for blood donors and, sometimes, the postponement of surgery when blood will be needed.
The FDA employs five layers of safety to ensure the availability of safe blood components, according to Davey. The first is the selection of suitable donors, which includes a donor history questionnaire and a limited physical evaluation. The second is donor deferral registries that identify people who are permanently deferred from donating blood. The third layer of safety is the testing of blood for infectious agents. The fourth is quarantining blood while verifying suitability. Lastly, the FDA takes corrective actions to address errors.
On the hospital side, the blood safety issues change. The biggest problem in the hospital setting is that incorrect blood may be transfused.
“Examples of things we support to address this issue are the use of hand-held bar code scanners and blood bag dispenser systems,” Davey said. “Some hospitals also use dedicated phlebotomists who specifically draw blood for transfusions only. Transfusion safety officers, when present, work with doctors and nurses to improve patient safety during transfusions.”
All blood donations are tested for HIV, hepatitis C, -B, and other pathogens. More recently, blood donations began being tested for Chagas disease.
“We are monitoring other diseases that might threaten the blood supply, such as dengue virus and XMRV,” Davey said. “We are aware of these potential threats and will take action if necessary.”