The Food and Drug Administration on Tuesday approved the first system that could be used by blood banks to destroy viruses and bacteria in donated blood plasma, potentially making transfusions safer.
The system represents an extra safety step beyond testing donations for viruses like H.I.V. and hepatitis C, and one that can protect against pathogens that seem to emerge periodically, as well as the known ones.
“You can’t test for something unless you know what it is,” said William M. Greenman, the chief executive of Cerus, the company that developed the product, which is known as the Intercept Blood System. He said Intercept was “much more comprehensive than what you would be able to achieve with testing.”
The product is being used in a clinical trial in West Africa to make plasma donated by Ebola survivors safer to use as a possible treatment for people who still have the disease.
Some experts in blood transfusions said, however, that it was far from clear that Intercept would be widely used in the United States, where the blood supply is already deemed safe. Testing of donated blood for various viruses will continue, they said, so the Intercept treatment would represent an additional cost.
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“The nonprofit blood collection industry can’t afford it,” said Dr. Michael P. Busch, director of the nonprofit Blood Systems Research Institute and a professor at the University of California, San Francisco. “Blood is extraordinarily safe now.”
The system involves adding a chemical to the plasma or platelets and then exposing them to ultraviolet light. The light causes the chemical to bind to any DNA or RNA in the sample, rendering bacteria, viruses or other pathogens unable to replicate. The plasma and platelets do not need RNA or DNA to function, so they are not harmed, at least in theory.
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