OCT. 24–EAST HILLS, NY–The U.S. Food and Drug Administration (FDA) has granted clearance to Pall Corp. to market a system that detects bacterial contamination in platelets.

The launch of the Pall BDS comes at a time when the nation’s blood safety experts have called for immediate action from the blood banking community to initiate a program to detect the presence of bacteria in platelets.

The risk of receiving contaminated platelets is 50- to 250 times higher than the combined risk if transfusion-related infections from HIV, hepatitis and human T cell leukemia.

“Bacteria are the most common infectious agents transmitted by blood and are a far greater threat to patient health than viruses such as HIV and hepatitis,” says Roslyn Yomtovian, director of blood bank transfusion medicine services and associate professor of pathology at University Hospitals of Cleveland.

“The Pall BDS gives us a novel approach to address the long-standing problem of bacterial contamination of platelets; a problem that has been eluding us for years,” she adds.

Platelet contamination is the leading cause of death and spread of disease from transfusion-transmitted infection.

According to Pall, studies conducted with bacteria strains reportedly caused 98 percent of the fatalities due to contaminated platelets in the United States have shown that the BDS accurately detects both gram-positive and gram-negative bacteria.

“By combining our filtration and knowledge of blood, Pall was able to develop this detection system, which can be incorporated easily into the blood banking process,” says Sam Wortham, president of Pall Medical Group.