Baxter Healthcare agrees plan to fix defective drug pumps
30 June 2006 00:00 in Medical Company Product News
Baxter Healthcare has agreed a plan with the FDA to allow it to resolve design flaws in its Colleague and Syndeo drug pumps.
As part of the agreement, Baxter will cease production and distribution of the pumps until they correct the deficiencies and bring the pumps up to the standards required by the FDA's current good manufacturing process regulations.
Drug pumps are electronic devices designed to deliver medications to patients in a controlled fashion but if they malfunction, the consequences could be severe.
Daniel Schultz, medical director of the FDA's centre for devices and radiological health, stated: "Infusion pumps deliver life-saving drugs and nutrition to thousands of critically ill patients. But if they don't work properly, patients are put at risk."
"Baxter has clearly had significant problems with some its infusion pumps. With this action today, Baxter has agreed to correct those problems," he added.
Baxter said that safety and patient well-being were its top priorities. Robert L Parkinson Jr, Baxter chairman and chief executive, stated: "The agreement we've reached with FDA provides a clear path to resolving the Colleague and Syndeo issues, so that we may continue to serve patients and medical professionals by delivering the quality, reliability and innovation they expect from Baxter."
The estimated cost of the alterations will be $70 million dollars, although the company said that aside from this, the company's financial outlook for 2006 was unaltered.
Baxter's agreement with the FDA follows the confiscation of drug pumps in 2005. Under the terms of the deal, no fines will be imposed on Baxter and the pumps may be remarketed following FDA approval.
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