Printer Friendly


 DEERFIELD, Ill., Feb. 3 /PRNewswire/ -- The Fenwal Division of Baxter Healthcare Corp. today announced U.S. Food and Drug Administration approval of the first plastic blood collection container system manufactured without the plasticizer di-2-ethylhexyl-phthalate (DEHP). Baxter scientists developed the new DEHP-free plastic formula, called PL2209(TM) plastic.
 "The blood-transfusion community has been concerned with the continued use of DEHP as a plasticizer, because its metabolites have been shown to cause cell abnormalities in some animal models," said Edward L. Snyder, M.D., professor of laboratory medicine at Yale University, and associate director of the Blood Transfusion Service at Yale-New Haven Hospital, a site where clinical trials of PL2209 plastic containers were performed.
 In studies published in the 1970s, DEHP -- the substance in plastic blood containers that makes them pliable -- was found to "leach" into blood during storage at a predictable rate, causing low levels of contamination. This leaching is caused by the presence of fat -- or lipids -- in the blood. DEHP leaching does not occur when the container is holding non-lipid fluids such as saline or glucose solution. Blood donors are not exposed to DEHP during the donation process.
 In response to these findings, Baxter scientists pursued alternatives to DEHP. The newly approved PL2209 plastic containers incorporate butyryl-trihexyl citrate (BTHC) as the plasticizer that replaces DEHP. Significantly less leaching occurs with BTHC, and its metabolites are easily processed by the human body.
 "Having BTHC as an alternative plasticizer is a major advance because it removes the source of DEHP metabolities and thus improves the quality of stored blood," Snyder said.
 The American Red Cross, the largest U.S. consumer of blood container products, is initiating a three-month, four-site evaluation of the PL2209 plastic container system. "We are asking blood collection centers in four metropolitan areas to evaluate this system for overall performance," said William C. Sherwood, M.D., acting chief operating officer and responsible head, American Red Cross Blood Services. "If we are pleased with the results, we plan to convert the entire Red Cross blood collection network to the PL2209 plastic container system."
 The American Red Cross collects approximately one-half of the 13 million annual blood donations in the United States. Worldwide, there are more than 70 million blood collections each year.
 Clinical studies have shown that PL2209 plastic is comparable to other plastics for storing red blood cells and platelets. The plastic container system has already been approved and is being used in several European countries, where it was found to be more durable than existing plastics for frozen storage of blood plasma.
 The world leader in providing systems and products for the collection, storage and transfusion of blood, Baxter's Fenwal Division was founded in 1947 by Carl Walters, M.D., the inventor of the plastic blood bag. "The PL2209 plastic container system is another in a long line of Baxter products that enhance the quality of stored human blood and blood components," said Timothy Anderson, president of Baxter's Fenwal Division.
 Baxter Healthcare Corp. is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter, headquartered in Deerfield, is the leading manufacturer and marketer of health-care products, systems and services worldwide.
 -0- 2/3/92
 /CONTACT: Geoffrey Fenton of Baxter Healthcare, 708-948-3436/
 (BAX) CO: Baxter Healthcare Corp. ST: Illinois IN: MTC SU:

GK -- NY073 -- 6229 02/03/92 13:23 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Feb 3, 1992

Related Articles
Cerus Study Shows Gamma Irradiation Can be Combined with Its Proprietary Pathogen Inactivation System for Platelets
FDA Approves Manufacturing Upgrades At Baxter's Glendale, Calif. Processing Facility.
Kraemer Succeeds Loucks as Baxter CEO.
Baxter, Shareholders Clarify Company's Plans For Materials Development.
Responding to Public Concern, Nation's Largest IV Products Manufacturer To Phase Out Vinyl IV Bags.
Baxter and Haemonetics Sign Agreement for Baxter/Cerus Pathogen Inactivation Technology for Platelets; Worldwide Agreement Expected to Expand Access...
Baxter Joins The Children's World Blood Bank's Efforts to Increase Access to A Safe Global Blood Supply for Children Worldwide; Children's World...
ZEVEX Launches Next-Generation DEHP-Free Enteral Pump Delivery Sets.
Baxter Announces FDA Clearance Allowing Blood Centers to Pursue Use of AMICUS-Collected Platelets Stored Up to Seven Days.
Baxter Announces New AVIVA Line of Intravenous Solutions.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters