Acrodose PL System. Enhanced Patient Safety. A New Platform for Pre-storage Pooling and Testing of Leukoreduced Whole Blood Derived Platelets

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1 Acrodose PL System A New Platform for Pre-storage Pooling and Testing of Leukoreduced Whole Blood Derived Platelets Enhanced Patient Safety

2 Pall Acrodose PL System Implementation of the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) standards for bacteria testing of platelets ushered in a new era of vigilance in transfusion medicine. Now, the role of whole blood derived platelet products is the beneficiary of a new safety platform based on pre-storage pooling and bacteria testing of leukoreduced platelets. A New Platform for Platelet Transfusion Safety Acrodose PL System Pall ebds Leukotrap RC PL and Leukotrap PL Systems As the leader in whole blood collection and filtration system solutions, Pall Medical expands the options in platelet transfusion therapy by introducing the Pall Acrodose PL System. Pre-storage pooling with the Acrodose PL System completes the platelet transfusion safety platform as it easily integrates with the Leukotrap RC PL Collection and Filtration System, and Pall ebds Bacteria Detection System. The system enables blood collection facilities to provide a therapeutic dose of whole blood derived platelets that are leukoreduced, ABO matched, bacteria tested and standardized to meet hospital needs. An Acrodose SM Platelet represents a transfusion-ready blood product that lowers handling costs at the hospital by eliminating additional processing or testing prior to transfusion. Working together, this platform offers blood facilities a real alternative to optimize the availability, safety and cost of transfusion platelets. An Acrodose Platelet: Represents a transfusion ready platelet for the hospital that is leukoreduced, ABO matched, pooled and bacteria tested. Enhances patient safety with culture-based bacteria testing for whole blood derived platelets. Lowers hospital handling costs by eliminating the need for pooling and bacteria testing at the hospital. 2

3 Providing Greater Patient Safety and Lower Bacteria Detection Costs Increased Sensitivity with Culture Based Detection Enhance safety and improve availability: Pall's new AcrodoseTM PL System, anchored by the integrated ebds, enables blood collection facilities to increase the availability of whole blood derived platelets tested with one of the most sensitive culture based bacteria testing methods available. Increase whole blood platelet safety with Pall ebds: Dipsticks and ph meters are less sensitive than culturebased systems. Studies have shown 99.3% detection was achieved in testing leukocyte reduced platelet pools contaminated with 1 CFU/mL of bacteria (Table 1). Increase Standardization and Efficiency Reduce labor at the hospital: By providing a transfusionready platelet, there is no need for pooling and bacteria testing at the hospital. This results in reduced hospital handling costs. Ensure a consistent, therapeutic dose from pooled whole blood platelets: Prepared in a cgmp environment, an Acrodose SM Platelet allows for the flexibility of customized dosing, designed to meet hospital needs. Lower Bacteria Testing Costs Improve testing efficiency: With the Acrodose PL System, there is no need to test each individual platelet concentrate. Bacteria detection is performed by a single ebds test per therapeutic dose. This optimizes the process and reduces the cost of testing whole bloodderived platelets. Reduce the risk of false positives: The Acrodose PL pre-storage pooling system integrates ebds for efficient, closed-system handling, unlike other culture-based testing systems. This results in a reduced risk of cross contamination during bacteria testing. Lower false positives mean less product loss. 3

4 Pall Acrodose PL System Check Valve Prevents potential backflow of sample pouch contents to protect the Acrodose SM Platelet. Slows flow into sample pouch to ease filling. Clamp Controls pooling process and air elimination from storage bag. Pall ebds Sample Pouch Integrated ebds provides culture-based bacteria detection. Unique bar code ID allows for complete traceability using Pall Data. 1.5L CLX -HP Storage Bag Designed to hold 2.2 x to 5.8 x platelets for up to five days after blood collection. Maintains platelet ph over the shelf life of the pooled platelets. Manifold Tubing Leads Six tubing leads for sterile connection to the whole blood platelet units. Dimensions and composition of the tubing meet the requirements for sterile connection devices. 4

5 Featuring Quality Design and Reliable Performance Table 1 Bacteria Levels in Pools at Time of Sampling and Detection by ebds Bacteria Detection System Bacteria # Detected/# Tested Total Cases at Various CFU/mL Levels of Detection >51 CFU/mL CFU/mL CFU/mL CFU/mL (# Detected/# Tested) Staphylococcus epidermidis 15/16* 7/7 1/1 4/4 27/28 Staphylococcus aureus 3/3 1/1 1/1 5/5 10/10 Streptococci agalactiae 8/8 8/8 Pseudomonas aeruginosa 2/2 3/3 10/10 15/15 Salmonella choleraesuis 1/1 3/3 7/7 11/11 Escherichia coli 6/6 2/2 7/7 15/15 Enterobacter cloacae 3/3 2/2 4/4 5/5 14/14 Bacillus cereus 3/3 5/5 2/2 10/10 20/20 Klebsiella pneumoniae 4/4 2/2 4/4 10/10 Serracia marcescens 5/5 10/10 15/15 Total 50/51 25/25 19/19 51/51 145/146 (99.3%) * 1 missed detection with 1 CFU/mL in pool; no bacteria were cultured from ebds pouch sample. Studies were conducted on 146 pools of whole-blood-derived, leukocyte-reduced platelet concentrates (PCs). Individual PC were inoculated with a target dose of 1-25 CFU/mL with the bacteria listed. After hours, either the PC was mixed with 5 other PC to form a pool, or 10 ml of the PC was removed and mixed with 10 ml from 5 other non-inoculated PC to form a pool. Samples of the pools were taken for culture (CFU/mL) and ebds testing immediately after pooling. Samples were incubated at 35 C for 24 hours, followed by testing for bacteria by measuring % oxygen. Of the 146 inoculated pools tested, 145 were detected. The one that was missed had a culture value of 1 CFU/mL and no bacteria were cultured from the sample contained within the ebds sample pouch. In summary, these studies have shown the Pall ebds detected 99.3% of aerobic and facultative anaerobic bacteria when testing leukocytereduced platelet pools contaminated with 1 CFU/mL of bacteria. 5

6 Completing the Platform for Platelet Transfusion Safety Produce Leukocyte Reduced Whole Blood Derived Platelets with Leukotrap RC PL and Leukotrap PL Systems Leukotrap RC PL and Leukotrap PL Systems provide a unique combination of technologies to enhance transfusion safety and operating efficiency. They are the only inline filtration systems capable of producing leukocyte reduced whole blood platelets and plasma. Providing efficient filtration for platelet rich plasma, the ATS LPL filter allows for semi-automated processing. Pall ebds Developed to Make Bacteria Detection Simple and Effective Pall ebds and Pall Data* have been uniquely designed for blood collection facility quality control and compliance. Pall ebds is a novel detection method that measures the oxygen content of air within the sample pouch as a surrogate marker for bacteria. If bacteria are present in the platelet sample collected, an increasing amount of oxygen is consumed through the metabolic activity and proliferation of the bacteria in the sample during incubation, resulting in a measurable decrease in oxygen content within the sample pouch. Pall Data management system tracks and manages all time-critical steps in the platelet process and provides a complete, traceable record from individual donor collection to pooled platelets to ebds results. *Pall Data with Workflow module is subject to FDA clearance and is available for beta testing in the USA. 6

7 Meeting A Higher Standard of Care While culture-based methods for bacteria detection have emerged as the standard of care for single donor platelets, less costly and less sensitive methods such as dipsticks and ph meters have been used for testing whole blood derived platelets. This has created a two-tiered approach to platelet bacteria testing. The New Pall Acrodose PL System offers blood collection facilities a real alternative to optimize the availability, safety and cost of platelet transfusion. The system enables blood facilities to provide a therapeutic dose of whole blood derived platelets that are leukoreduced, bacteria tested, ABO matched and standardized for your hospital s needs. Product Indications Suitable for pooled, leukoreduced, ABO matched platelet concentrates from whole blood collected with the Pall Leukotrap RC PL or Leukotrap PL System using CP2D as anticoagulant. Store pools of 4 to 6 units (40 to 65 ml) of leukoreduced platelet concentrates in plasma for up to 5 days. Ordering Information Reorder Code Description Packaging Pall Acrodose PL 40 units System per case 7

8 United States 2200 Northern Boulevard East Hills, NY toll free phone (USA) phone fax International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States and Venezuela. Distributors in all major industrial areas of the world. The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. 2005, Pall Corporation. Pall,, Acrodose, CLX, and Leukotrap are trademarks of Pall Corporation. indicates a trademark registered in the USA. and Acrodose are service marks of Pall Corporation , 1K, GN PN 33397