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New transfusion rules restrict donations from previously pregnant women

East Hills, NY (Oct. 2, 2007) -- New recommendations that restrict women who have previously been pregnant from donating platelets and plasma will have a major impact on the blood supply. The reason is a potentially deadly protein associated with Transfusion Related Acute Lung Injury, or TRALI. According to the FDA, TRALI is the leading cause of transfusion-related deaths in both male and female patients. Pall Corporation (NYSE: PLL), a leading blood safety company, is helping blood banks and hospitals fill transfusion shortfalls with a new technology that efficiently provides a safe supply of platelets, a life-saving blood product used to aid clotting.

TRALI is a serious pulmonary syndrome which may lead to death if not promptly recognized and treated. It is linked to antibodies found in the blood of some women who have had one or more pregnancies or some donors who have been previously transfused. The protein, antibodies to human leukocyte antigen (HLA antibody), is found in the blood of about one in five women donors. TRALI can occur when these antibodies in the donors blood react with the white blood cells (leukocytes) of the transfusion recipient. This causes changes in the recipients lung tissue that allows fluid to enter, resulting in acute pulmonary edema (fluid accumulation). Platelets derived from single-donor collection (apheresis) and plasma for transfusion are disproportionately associated with TRALI fatalities.

The new AABB recommendations state that blood collection centers should institute procedures to reduce the risk of TRALI from plasma donation by November 2007 and from platelet donation as soon as possible but no later than November 2008. AABB is the organization that sets standards and provides accreditation for transfusion medicine services.

Implementing the new recommendations is already leading to significant changes in the way blood banks handle donations, especially those from women. Although the guidelines do not impact the ability for women to donate whole blood, it does curtail their donation of high plasma volume blood components such as apheresis platelets. Deferring this segment of the population is estimated to potentially affect as many as 50 percent of the female donor base or several million women. Many centers, including the American Red Cross (ARC), are already starting to shift to predominantly male donors for some blood products. These changes will undoubtedly shrink an already dwindling donor pool and have a serious impact on the ability to meet the ever increasing demand for blood products for transfusion. To counter the problem, blood centers are adopting the Pall AcrodoseTM PL System to help ensure the availability of safe platelets despite the new donor restrictions. The Acrodose PL System enables blood banks to use the existing resources of valuable whole blood to efficiently obtain a transfusion-ready, therapeutic dose of platelets.

The resulting AcrodoseSM Platelets are leukocyte reduced, matched for blood type and tested for bacteria using a sensitive culture-based system, the same type of state-of-the-art systems that are used to test apheresis platelets. They are clinically equivalent in terms of platelet count and quality to those derived from apheresis, but at a lower cost. With the Acrodose PL System, blood centers and hospitals will no longer have to rely on apheresis platelets, which are both expensive and time-consuming to collect, and have already been associated with blood shortages.

Balancing Blood Safety and Availability

Maintaining a safe and available blood supply is a constant balancing act. Today, only about five percent of the eligible donor population actually gives blood. According to the AABB, ensuring an adequate supply of blood is increasingly more challenging. Donor deferrals have increased over the years due to added restrictions and more thorough screening based on behaviors which place prospective donors at risk for transmitting certain infections including travel to certain countries.

Its a constant struggle to find a balance between maintaining a sufficient number of donors and ensuring the availability of blood while also limiting risk to the blood supply, says Allan Ross, President of Pall Medical and former Chief Operating Officer of the American Red Cross Biomedical Services. Experts agree we can no longer afford to waste valuable blood products derived from whole blood collection. With the knowledge that TRALI is the leading threat to the blood supply today, the Acrodose PL System takes on an added value for blood banks and hospitals. It not only helps them save costs but helps them ensure the availability of life-saving platelets for their patients.

Platelets are in high demand for people with leukemia, blood disorders, cancer; recipients of bone marrow or organ transplants and accident, burn and trauma victims. Platelets are a valuable resource that must be transfused within five to seven days of collection before expiring and being discarded.

TRALI Incidence

Incidence of TRALI is estimated to be about one in 1,300 to 2,400 transfused components and is also estimated to be a contributing factor in about 220 deaths annually. ARC reports that suspected TRALI fatalities climbed steeply between 2003 and 2005. According to the National Heart, Lung and Blood Institute, although TRALI is the leading cause of transfusion-associated mortality, it is probably still under recognized and under reported. There is currently no screening test for the prevention of TRALI, and, there is no single intervention that can eliminate the risk of TRALI.


Contact: Marcia Katz
Pall Corporation

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