FDA offers statistical evidence

By Gary Tufel

Blood banking has faced more than a few challenges in the past. Industry experts have cited a shortage of trained personnel, safety issues (such as keeping blood samples safe), automation, and controlling increasing costs, as well as the need for self-regulation, establishing and strengthening already stringent guidelines, and improving and maintaining sample quality.

But at the same time, according to the annual summary of transfusion-related fatalities reported to FDA, the blood supply is safer today than at any time in history. “Due to advances in donor screening, improved testing, automated data systems, and changes in transfusion medicine practices, the risks associated with blood transfusion continue to decrease,” says the agency’s most recent report.1

Figure 1. Transfusion-related fatalities by complication, FY2010 through FY2014. Source: Center for Biologics Evaluation and Research, FDA.

Figure 1. Transfusion-related fatalities by complication, FY2010 through FY2014. Source: Center for Biologics Evaluation and Research, FDA. Click to enlarge.

For example, in fiscal year (FY) 2014 there was one reported fatality attributed to microbial infection, compared to five in FY2013 (see Table 1 and Figure 1). “Overall, the number of transfusion-related fatalities reported to FDA remains small in comparison to the total number of transfusions. In 2011, for example, there were approximately 21 million blood components transfused. During the proximate period of FY2011, there were 58 reported transfusion-related and potentially transfusion-related fatalities, with subsequent reports of 65 in FY2012, 59 in FY2013, and 56 in FY2014.”1

Further statistical evidence of blood banking and transfusion safety is presented in our companion article, “Stats Show Safest Time in History for Transfusions.” But what are the reasons for the current success?


Tony Casina, Ortho-Clinical Diagnostics.

Tony Casina, Ortho-Clinical Diagnostics.

What advances are responsible for the current effectiveness and safety of transfusion and transplantation medicine? Considering that transfusion is a form of transplantation, transfusion medicine is now advancing the cause of “precision” medicine for pretransfusion testing to provide compatible blood, says Tony Casina, marketing manager for Ortho-Clinical Diagnostics (OCD), Raritan, NJ.

“This is particularly true in patient populations that are frequently transfused and ultimately, when treated with more random transfusions of red cells, are prone to develop blood-group antibodies,” says Casina. “The newer approach with these populations is to provide more exact matching of the blood so that improved patient outcomes becomes the definitive goal. This approach should lead to lower levels of blood group alloimmunization, enhanced ability to find blood to transfuse, reduced potential for transfusion reactions, and improved patient quality of life.”

For Eva D. Quinley, MS, MT(ASCP), chief operating officer at Medic Regional Blood Center, Knoxville, Tenn, and regional executive director of Lifesource, ITxM, Chicago, Ill, key advances include specialized products that address specific needs of the patient, including the development of new storage solutions that extend product shelf life, and the development of machines that can separate blood components, retain what is needed, and return the rest to the donor.

Eva Quinley, MS, MT (ASCP), Medic Regional Blood Center and Lifesource, ITxM.

Eva Quinley, MS, MT (ASCP), Medic Regional Blood Center and Lifesource, ITxM.

Quinley highlights especially the development of surgical techniques that use less blood, and the use of alternatives to transfusion, “the whole patient blood management movement, which includes scrutinizing each and every transfusion to ensure it is necessary. Although this decreases revenues for blood centers, it is the right thing for the patient, and it results in cost savings for the hospital.

“Cellular therapies have been key in the treatment of many diseases,” Quinley adds.” More and more, use of personalized medicine that incorporates some sort of cellular therapy is in our future.”


Recent advances include the ability to gather multiple components during collection, longer shelf life, inactivation of pathogens, and the ability to harvest a particular cellular element, says Quinley.

Marianne Hoonakker-Kelly, Sunoco ThermoSafe.

Marianne Hoonakker-Kelly, Sunoco ThermoSafe.

“At a very high level, advanced technologies have supported the need within blood banking to drive clinical outcomes, deepen operational efficiencies, and support the push for improved economic outcomes,” says Marianne Hoonakker-Kelly, business development manager at Sunoco ThermoSafe, Arlington Heights, Ill.

“The market’s adoption of technology that ensures the safe handling of blood feeds the quality of processes that promote improved patient care. Standardizat