This article is more than 5 years old. Information may no longer be current.
Blood donations go through five layers of safety
Click Here to Manage Email Alerts
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 Research.
“Blood is highly regulated, not just by the FDA, but also by state regulations and CDC regulations, as well as regulations by 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.
There are five layers of safety that go into effect when a person donates blood, 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.
“Some things we support to deal with this issue is 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. A transfusion safety officer may also work on the floor with doctors and nurses to improve patient safety during transfusions.”
All blood donations are tested for HIV, hepatitis C and hepatitis B, and more recently, blood donations began being tested for Chagas disease.
“We are watching for other diseases that might come up, such as dengue and XMRV,” Davey said. “We are aware of these potential threats and will take action if necessary.”
 |
Follow InfectiousDiseaseNews.com on Twitter. |