East Hills, NY (September 5, 2006) -- Pall Corporation (NYSE: PLL) announced the CE marking of its eBDS System to detect bacterial contamination of red blood cells, the most widely transfused blood component. The Pall eBDS is a highly sensitive culture-based test routinely used by blood centers to detect bacterial contamination of platelets, the leading infectious cause of sickness and death from a transfusion. Results of a new study presented at the International Society of Blood Transfusion (ISBT) 2006 Congress show the efficacy of the system in also detecting bacteria that are commonly found as contaminants of red blood cells.
Since the availability of the Pall eBDS for detection of bacteria in platelets, there has been interest in applying the same technology to improve safety of red blood cells. Recent studies have documented sepsis and death caused by transfusion of contaminated red cells, with the bacteria Yersinia enterocolitica most often implicated. The U.S. FDA estimates that the rate of bacteria associated adverse reactions from Yersinia is one per 500,000 units of red cells, although they note that this rate may be underestimated. The U.S. Centers for Disease Control and Prevention (CDC) estimates bacterial contamination of red blood cells at one per million units whereas other nations have reported incidence as high as one in 65,000 units with a fatality rate of one in 104,400 units.
Despite the unknown actual number of cases, there is no question that transfusion of a contaminated red blood cell, especially if contaminated with gram-negative bacteria, is a rapid and catastrophic event with a quick onset of sepsis and greater than 60 percent mortality rate. Multiple studies have also documented a link between transfusion of red blood cells with nosocomial (hospital-acquired) infection. Critically ill patients who receive red cell transfusions are at increased risk of a nosocomial infection with a significant increase in mortality and
Contact: Marybeth Nibley