Pall system to detect blood bacteria given CE mark
Pall eBDS effective for red cell and platelets
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/or length of stay in intensive care.
"Adding bacterial detection of red cells along with platelets can have a significant impact on the safety of the blood supply," says Allan Ross, President, Pall Medical. The blood centers that employ the Pall eBDS for platelet testing can simply and readily use it to detect bacteria in red cells. This is a highly cost-effective way to help them ensure they can provide the safest blood for transfusion."
The Pall eBDS uses a novel approach to detection by measuring oxygen consumption as the marker for bacteria. If bacteria are present in the blood sample collected, an increasing amount of oxygen is consumed through the metabolic activity and proliferation of the bacteria during incubation, resulting in a measurable decrease in oxygen content.
The study presented to the ISBT tested the Pall eBDS on 662 red blood cell samples that had been inoculated separately with twelve different bacteria strains. Each sample was tested after 48 hours resulting in 100 percent detection of the contaminating bacteria. Pall, the leading global provider of filtration and other technologies to enhance the safety of the blood supply, conducted this study in response to the need to reduce the problem of bacterial contamination of blood components.
#1 Infectious Source of Transfusion-Transmitted Disease
There has been an astounding reduction in the risk of viral infections from a blood transfusion, especially with routine testing for viruses that cause diseases such as hepatitis and AIDS. As a result of these advances, the risk of infection from bacterial contamination of blood products exceeds that from viral agents and has emerged as the greatest residual infectious source of transfusion-transmitted disease. Bacterial contamination is most often found in platelets and the use of a sensitive culture-based detection test, such as the Pall eBDS, is helping solve the problem. Since the introduction of Pall's AcrodoseTM PL System, more blood centers are moving forward in providing whole-blood derived platelets to alleviate platelet shortages. It allows blood centers to efficiently conduct a single culture-based bacterial contamination test for a bacteria-free, transfusion-ready therapeutic dose of platelets. Using the Pall eBDS, these centers will be able to ensure that red cells derived from whole blood collection are also free from contaminating bacteria.
As some nations urge greater use of autologous red blood cells (a person's own pre-donated blood) for transfusion, especially for non-emergency surgical patients, concerns about the safety of this blood has become more paramount. It is not generally appreciated that autologous blood may not be safe from bacteria and can become contaminated whether it's from environmental factors, skin contamination at the time of donation or during the handling and processing after collection. In the U.S., one in 16,999 autologous units has 12 times more likely risk of contamination than those associated with community donations from healthy individuals. Japan is one of the nations currently investigating bacteria contamination of autologous red cells and is using the Pall eBDS as one of its study methods. Testing autologous red blood cells for bacteria can ensure it's safe use to help conserve and supplement the blood supply to alleviate emerging blood inventory shortages.
Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, semiconductor, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2005 were $1.9 billion. The Company headquarters is in East Hills, New York with extensive operations throughout the world. Visit Pall at www.pall.com.
- Photos and additional information about the Pall eBDS along with a Scientific and Technical Report on the study results can be found on http://www.pall.com/corporate_40982.asp
- Visit the Pall booth Stand 5, Hall 1B at the 29th Congress of the International Society of Transfusion Medicine in the International Conference Centre, Cape Town, South Africa from September 2 through 7.
- The CE mark certifies that the product meets the safety and efficacy requirements for it to be marketed throughout the European Union.
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