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St. Mary Medical Center Announces New Safety Measure to Prevent Sepsis
New test added to increase safety for patients receiving blood transfusions

LANGHORNE, PA, April 19, 2012 — St. Mary Medical Center is among the first medical centers in the Delaware Valley region to begin using a new test to check for potential bacterial contamination in blood platelet products used in transfusion. St. Mary Blood Bank Technicians now use the Verax Platelet PGD® test to check platelet products before a transfusion is administered at St. Mary. The Platelet PGD Test is the only test approved by the FDA as a safety measure for the detection of bacterial contaminants in platelets within 24 hours prior to transfusion.

St. Mary is pleased to add this additional testing as a means to advance our commitment to patient safety. “We believe this additional testing of transfusion products performed shortly before they are given to our patients is important in our continuing efforts to ensure patient safety. This latest testing tool has the potential to save lives and protect our patients from possible contaminants that may not be apparent within the standards of earlier testing performed as part of the collection process,” says Thomas Flatley, Administrative Director of Laboratory Services at St. Mary.

Blood collectors perform culture tests for bacteria in apheresis platelets 24 hours after donation, analyze results and dispose of contaminated units. But bacteria levels at the time of collection may not be present in large enough quantities to be captured in the culture sample. Contaminated platelets that initially tested as negative can potentially be shipped to hospitals and prepared for patient use.

Published studies demonstrate that bacterial contamination in platelets is the most important infectious threat to transfusion safety. Implementing this test is an important way that hospitals can help eliminate septic reactions from bacterially-contaminated platelet units. A recent study published in the medical journal Transfusion examined more than 27,000 platelet transfusions. Eighteen hospitals participated in the study. The study confirmed the ability of the Verax Platelet PGD® test to detect bacteria missed by culture testing and enabled clinicians to prevent potentially deadly infections in patients.

In September 2011 the U.S. Food and Drug Administration (FDA) said the Verax Platelet PGD® test can now be labeled and marketed as a “safety measure” for leukoreduced apheresis platelets, the type of platelets used for transfusion at St. Mary. The Verax Platelet PGD test was developed by Verax Biomedical of Worcester, Mass., and is marketed and sold globally by Fenwal Inc. of Lake Zurich, Ill. The Verax Platelet PGD® test is the only rapid test for the detection of bacteria in platelets that is cleared by the FDA.

More than 100 platelet doses are transfused monthly at St. Mary Medical Center. Platelet transfusions are typically needed to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, following major trauma, during or after surgery, and in patients who are not able to produce platelets.