FDA Clears Pall Corporation's Enhanced Bacteria Detection System

EAST HILLS, N.Y. -- Pall Corporation announced today that the U.S. Food and Drug Administration (FDA) granted clearance to market the new Pall eBDS system. The enhanced Bacteria Detection System offers a more sensitive and easy method for detecting bacteria in blood platelets. Its increased sensitivity will improve patient safety by allowing blood banks to accurately detect the lowest levels of bacterial contamination without false positive results so that viable platelets are not discarded and wasted. The Pall eBDS system can detect bacteria in all platelets whether derived from single donor (apheresis) or whole blood (random donor) collection procedures.

The new system is designed to reduce overall testing time by as much as 20 percent. This helps improve availability of blood for transfusion by allowing faster access to platelets found to be bacteria free prior to becoming outdated. Platelets are a highly valuable life saving resource with a shelf life of only five days.

The availability of the enhanced system comes at a critical time. Effective March 1, 2004, blood centers must begin testing all platelet components for the presence of bacteria, according to a new American Association of Blood Banks standard which is the result of the transfusion community's recognition of the severity of the problem associated with contaminated platelets and the availability of technology to address it. Bacterial contamination of platelets is the leading infectious cause of transfusion-related patient fatalities. The risk of a patient receiving a bacterially contaminated blood transfusion is 1 in 4,000; far greater than the chances of the transmission of hepatitis C (one in 500,000) or HIV (one in a million).

"The Pall eBDS fulfills a critical need and provides a significant market opportunity since it is the only FDA approved method that can detect bacteria in whole blood derived platelets, which comprise about 75 percent of all platelets transfused each year in the U.S.," said Roberto Perez, president of Pall Medical. "It provides the most comprehensive, reliable and sensitive level of bacterial detection to help blood centers meet the new standard while assuring conformance to current good manufacturing practices (cGMPs)." There are 4.1 million random donor platelets and 1.4 million single donor platelets transfused annually in the U.S. primarily as a life-saving treatment for cancer, leukemia and other blood disorders.

Many of the nation's leading blood centers have already committed to using the Pall eBDS to help ensure safety of blood transfusions. "We are excited about implementing the new Pall eBDS for platelets," said Nancy Eckert, president and CEO of Lifesouth Community Blood Centers. "We have been using the original BDS technology for several months and just recently detected our first contaminated platelet unit averting a potentially serious patient reaction."

According to Dan Waxman, MD, executive vice president and chief medical officer of the Indiana Blood Center, "The enhancements of the new eBDS are a welcome addition to ensuring blood transfusion safety. The eBDS offers greater ease of use saving both time and labor and making it simple and practical to implement in our center." Indiana Blood Center, the primary supplier of blood and blood products to over 45 hospitals throughout Indiana, has had extensive experience using Pall's original bacterial detection system (BDS) and testing the new enhanced version.

The eBDS is a key step in Pall Medical's Bacteria Risk Management Program, which includes products to address contamination at every stage of blood collection and processing. It is an enhanced version of the company's BDS, which was launched in October 2002, and provides a faster, simpler method to detect bacteria with a higher degree of sensitivity and specificity. Other products Pall provides to address bacteria risk management include its Sample Diversion Pouch, which diverts the usually contaminated initial volume of donor blood during collection, and filtration technologies for leukocyte (white blood cell) reduction of both red cells and platelets.

Pall is a world leader in leukocyte-reduction filtration technologies. It is committed to developing new technologies that safeguard public health and improve transfusion safety, including extensive research and development on the removal of prions and other pathogens from blood.

Source: Pall Corporation