FDA Takes Action To Reduce Infusion Pump Risks

Law360, New York (April 23, 2010, 3:13 PM EDT) -- Targeting ongoing safety problems associated with external infusion pumps used to deliver medications and fluids to patients, the U.S. Food and Drug Administration is taking steps to push manufacturers to improve the design of the devices.

On Friday, the FDA issued new draft guidance and a letter to infusion pump manufacturers, warning them that the agency is working to establish additional premarket approval requirements for the devices.

Infusion pumps are widely used in hospitals or other clinical settings, allowing a high level of control and accuracy...
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