US FDA Nod For Baxter's Colleague Infusion Pump

Baxter Healthcare Corporation has received clearance from the US FDA on its Colleague infusion pump 510(k) pre-market notification. The company is preparing to modify pumps currently in the market and will soon submit manufacturing and service documentation to FDA in advance of deploying upgrades to US Colleague infusion pumps. Baxter will continue to communicate and work directly with customers in the coming months to establish deployment schedules and begin remediation activities.

"Resolving issues with the Colleague infusion pump has been Baxter's top priority. We appreciate customers' continued support as we've worked to develop modifications for the Colleague infusion pump," said, Peter Arduini, corporate vice president and president of Baxter's Medication Delivery business. "Baxter remains committed to our infusion systems customers and will continue to invest in this business to enhance the delivery of life-saving medications."

Baxter has completed deployment activities in key markets outside the US, with 58,000 pumps in 55 countries upgraded, and then resumed sales of Colleague infusion pumps in these markets.

In June 2006, Baxter and FDA reached agreement in the form of a consent decree, which describes steps Baxter must take to resume sales of new Colleague infusion pumps in the US. Currently, more than 200,000 Colleague infusion pumps are in use in US hospitals.

(Ref : Chronicle Pharmabiz dated March 8, 2007)