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News Release

 
 

Baxter Receives 510k Clearance from U.S. FDA for Wireless Connectivity and Monitoring for COLLEAGUE CX Infusion Pump

 

Wireless Connectivity Gives Healthcare Providers Access to Real-Time Patient Information and Remote Monitoring to More Safely Manage Infusion Therapy

 

Deerfield, IL – February 14, 2005 – Baxter Healthcare Corporation announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its wireless pump connectivity interface that enables hospitals to connect Baxter's COLLEAGUE CX® infusion pump to its Patient Care System.

 

The wireless connectivity system allows healthcare providers to capture real-time patient information when administering medication using the COLLEAGUE CX infusion pump, as well as monitor the status of these infusions via a hand-held computer. The wireless connectivity interface also enables healthcare providers to review pharmacy-entered prescription information to programmed pump settings at the bedside to ensure the appropriate administration of infusions.

 

“We have been using Baxter's Patient Care System for almost three years to manage patient medication administration and have already seen the benefit to patients in our ability to track and monitor their care,” said Peter Hoftsetter, chief executive officer of Northwestern Medical Center in St. Albans, Vt. “With the addition of the wireless connectivity interface to this system, our staff will be able to share real-time patient information and more closely monitor a patient throughout their infusion, have the ability to check the medication administration status and receive any alerts or alarms via a hand-held computer.”

 

With the new wireless connectivity interface, Baxter's Patient Care System helps clinicians track and verify the administration of infusions. First, the nurse scans the patient's bar-coded wristband to verify the patient information. Then the nurse scans the bar-coded solution container to verify and track in real-time the specific medication, the start time of the infusion as well as view any clinical alerts and pre/post-administrative actions that may be required for the patient.

 

“The option to connect our infusion therapy process at the point where the medication administration process begins will enhance our clinicians' ability to promote the five rights of patient safety that we all live by,” said Lorraine Mancuso, director of Education at North Adams Regional Hospital in North Adams, Mass. “The ability to have a system that allows healthcare providers to verify the right medication at the right dose via the right administration at the right time only enhances the efforts of our staff to promote the safety of all patients.”

 

The wireless connectivity interface will undergo software validation testing under a clinical study protocol at sites already using Baxter's Patient Care System. The clinical study will begin in the second half of 2005. Availability of this system to other hospitals, including the introduction of the new wireless connectivity interface, is planned for late 2005, following completion of the clinical study.

 

“Baxter's vision is to offer integrated infusion technologies to hospitals so that they can improve productivity by making the administration of medications more efficient as well as provide added verification systems to enhance safety at the point of care,” said Art Mollenhauer, general manager for Baxter Global Infusion Systems. “Now with the option to wirelessly connect Baxter's COLLEAGUE CX infusion pumps to its Patient Care System, hospitals have the ability to further reduce the possibility of errors, and to promote a safe healthcare environment.”

 

Baxter gives its customers a comprehensive overview of their patient's medication process, from the time the prescription is received in the pharmacy to the point of administering the medication. As part of Baxter's Medication Delivery product offering, the company also provides its ENLIGHTENED HRBC® bar-coding system, standardized dosages and premixed drug formulations, along with its COLLEAGUE CX infusion pump.

 

About Baxter


Baxter Healthcare Corporation is the principal operating subsidiary of Baxter International Inc.  Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients´ lives.


For more information, including details on Baxter's Patient Care System, please visit www.baxter.com.

 

Statements in this press release regarding the availability of the Patient Care System to other hospitals, including the introduction of the new wireless connectivity interface, are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risk and uncertainties related to the timing and results of clinical trials and other development activities, technological advances in the medical field, product demand and market acceptance, the impact of competitive products and pricing, and other factors described in the Company's filings with the Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise, and all forward-looking statements speak only as of the time when made. Actual results or experience could differ materially from the forward-looking statements.

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