The Center for Biologics Evaluation and Research (CBER), a division of the U.S. Food and Drug Administration (FDA), regulates the collection of blood and blood products that are used for transfusion.
Walter J. Linz, MD, Medical Director of the Scott & White Blood Center and Transfusion Medicine details how the FDA ensures the safety of the U.S. blood supply.
“When AIDS and HIV came out in the 1980s and 90s, people were legitimately dying from transfusions, so blood donor screening and testing became a lot more rigorous,” says Dr. Linz.
“From the mid-80s on to this date, the FDA has taken the position that they don’t care what it costs, they’re going to continually do things to make the blood supply safer and safer. They’re interested only in blood safety. That’s their job,” says Dr. Linz.
The FDA requires that all blood centers:
- Screen potential donors
- Test donated blood
- Maintain a list of deferred donors
Screen All Potential Donors
According to the FDA, blood donors are asked specific and very direct questions about risk factors that could indicate they might be infected with a transmissible disease. This screening eliminates around 90 percent of unsuitable donors.
“The current system of multiple checks works, and the blood supply has never been safer.”
“The questions are the same all over the nation. We can’t decide to leave some questions out or change the wording. There’s a certain uniformity to the questions. We use the most stringent criteria to keep out the blood of anyone if there’s a chance they could be sick,” says Dr. Linz.
However, the FDA allows questions to be added to their list of mandated questions.
“We have added a question about being pregnant or having been transfused, so that we can exclude the plasma of those who said yes. That helps us reduce the risk of transfusion-related acute lung injury,” says Dr. Linz.
Additionally, the FDA mandates the exclusion of certain groups of people from donating blood, based on certain behaviors or where they’ve traveled:
- Intravenous drug users
- Men who have sex with other men, at any time since 1977
- People who lived in certain European countries in the late 1990s who might be carriers of “mad cow disease”
Test All Donated Blood
“In addition to asking the series of questions — and then following up on any of those questions if any of them bring up a red flag — we test all that blood,” says Dr. Linz.
According to the FDA, donated blood is quarantined until it’s tested for:
- Hepatitis B
- Hepatitis C
- HIV 1 and 2
- Human T-Lymphotropic Virus, Types I and II
Any blood found positive for disease is considered unsuitable for transfusion.
Maintain a List of Donors
The FDA requires that all blood centers keep a list of unsuitable donors so that blood may not be collected from them. Scott & White Blood Center, as well as all other donor centers, maintains this list.
The blood supply at Scott & White is particularly safe, because the donor base includes a significant number of donors who donate on a regular basis.
“It’s always safer to get blood from someone who’s donated multiple times, because they’ve been screened multiple times — versus a first-time donor, because a first-time donor is higher risk. They may have something you don’t know about,” says Dr. Linz.
“The current system of multiple checks works, and the blood supply has never been safer,” says Dr. Linz.
Scott & White Blood Center is regularly inspected by the FDA and accredited by the College of American Pathologists and the AABB (formerly American Association of Blood Banks); all organizations work in cooperation with CBER to meet all mandated quality standards.