Baxter Receives FDA Clearance for Wireless Pump Connectivity Interface

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Baxter Healthcare Corporation for its wireless pump connectivity interface. This technology enables healthcare providers to connect Baxter's Colleague CX infusion pump to its Patient Care System, allowing for real-time monitoring and tracking of patient information during medication administration. The wireless connectivity interface also enables healthcare providers to review pharmacy-entered prescription information to programmed pump settings at the bedside.

Key Takeaways:

• The wireless pump connectivity interface enables hospitals to connect Baxter's Colleague CX infusion pump to its Patient Care System, allowing for real-time monitoring and tracking of patient information during medication administration.
• The technology also enables healthcare providers to review pharmacy-entered prescription information to programmed pump settings at the bedside to ensure the appropriate administration of infusions.
• The wireless connectivity interface will undergo software validation testing under a clinical study protocol at sites already using Baxter's Patient Care System, with the clinical study beginning in the second half of 2005.
• The system will be available to other hospitals, including the introduction of the new wireless connectivity interface, planned for late 2005, following completion of the clinical study.
• The wireless connectivity interface is designed to enhance safety and productivity in hospitals, by allowing healthcare providers to verify the right medication at the right dose via the right administration at the right time.
• The system will be used in conjunction with Baxter's Patient Care System, which has already been shown to benefit patients in managing medication administration.

Statistics:

• 510(k) clearance has been granted to Baxter Healthcare Corporation for its wireless pump connectivity interface.
• The clinical study for the wireless connectivity interface is planned to begin in the second half of 2005.
• The system is expected to be available to other hospitals by late 2005, following completion of the clinical study.
• The wireless connectivity interface will undergo software validation testing under the clinical study protocol.
• The system is designed to enhance safety and productivity in hospitals by reducing the possibility of errors and promoting a safe healthcare environment.

Sources:

• Baxter Healthcare Corporation
• U.S. Food and Drug Administration (FDA)
• Northwestern Medical Center
• Peter Hoftsetter, chief executive officer, Northwestern Medical Center
• Lorraine Mancuso, director of Education, North Adams Regional Hospital
• Art Mollenhauer, general manager for Baxter Global Infusion Systems
• Biotech Business Week
• NewsRx.com (NewsRx.com)