The Vital Role of Blood Transfusions: Understanding FDA Oversight and Safety Measures

Every day, hospitals across the United States rely on blood transfusions to save lives. Whether in the case of car crashes, fires, and emergencies, or to treat life-threatening illnesses and support surgeries, blood is a vital resource. Annually, millions of blood units are collected and transfused, making blood donation programs a cornerstone of modern healthcare.

Indeed, every two seconds, someone in the U.S. requires a blood transfusion. This need spans various scenarios, including cancer patients receiving chemotherapy, individuals with genetic blood disorders, organ transplant recipients, surgery patients, women undergoing labor and delivery, premature babies, and trauma victims. Given the ubiquity of blood transfusions, the importance of ensuring the safety and availability of blood cannot be overstated.

The Role of FDA Oversight

The U.S. Food and Drug Administration, through its Center for Biologics Evaluation and Research (CBER), oversees blood transfusion safety. CBER ensures the safety of the approximately 11 million units of whole blood donated each year, which can be further processed into components such as red blood cells, platelets, and plasma.

In addition to whole blood, apheresis processes collect about 4 million units of platelets and plasma annually. Source plasma, intended for further manufacturing and used in drugs such as immune globulins and albumin, sees over 40 million collections annually.

FDA regulations and guidelines protect both donors and recipients. These regulations govern blood donor eligibility, donation testing, and technology used in blood collection and pathogen reduction. FDA oversight encompasses reviewing biologics license applications, ensuring device safety, developing and enforcing regulations, inspecting facilities, and monitoring for potential issues, including adverse events and manufacturing deviations.

The Five Layers of Blood Safety

The FDA’s approach to blood safety involves five layers of safeguards designed to minimize the risk of infectious disease transmission while maintaining an adequate blood supply.

1. Donor Screening

Donors are educated about risk factors that may affect blood safety and are screened for medical history and risk factors. Individuals found to be ineligible are deferred from donation.

2. Donor Deferral Lists

Blood establishments maintain current deferral lists and verify donors against these lists to prevent the collection of blood from deferred individuals.

3. Blood Donation Testing

Post-donation, each unit of blood is tested for infections such as Hepatitis B and C, HIV, HTLV, syphilis, West Nile virus, Babesiosis, and Chagas disease. Pathogen reduction technology can be applied when appropriate.

4. Quarantine

Donated blood is quarantined until it’s tested and found free of transfusion-transmitted infections.

5. Problems and Deficiencies

Blood establishments must address and notify FDA of any manufacturing problems or deficiencies.

Continuous Safety Efforts

Emerging infectious disease threats and other risks require ongoing efforts to ensure blood safety. FDA scientists develop donation screening tests for new threats and study pathogen reduction technologies to enhance blood component safety. The Office of Blood Research and Review updates eligibility requirements and recommendations as needed.

As a member of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism, FDA works with other organizations, agencies, and manufacturers to maintain adequate blood inventories in emergencies.

The Process of Blood Donation

The blood donation process is designed to be safe and takes about an hour, including:

• Registering at the donation site.
• Answering health and travel history questions.
• Undergoing a physical assessment for vital signs and hemoglobin levels.
• Donating blood, which takes 15 to 20 minutes.
• Receiving a light refreshment before leaving.

Eligibility to Donate Blood

To donate, individuals must meet basic health criteria, including a normal pulse, blood pressure, temperature, and hemoglobin level. Other eligibility requirements include meeting state law age minimums, being free from transmissible infections, and not having donated blood in the past eight weeks.

Donation may be deferred for certain temporary or permanent reasons, such as:

• Not feeling well on the day of donation.
• A history of nonprescription injection drug use.
• Getting a tattoo in the last three months.
• Having specific medical conditions or treatments.
• Traveling or residing in areas endemic for certain infections.

For more detailed eligibility requirements, refer to FDA Blood Guidances.

Given the critical nature of blood transfusions and the importance of blood for saving lives, understanding the safety measures and eligibility criteria is essential. Donating blood is a commendable act that can help support hospitals and save countless lives in emergencies and routine medical procedures.