FDA tightens oversight of drug pumps

Posted on Apr 26, 2010

The U.S. Food and Drug Administration announced Friday that it will take steps to improve the design and safety of drug infusion pumps that have been linked to more than 700 deaths in the past five years.  Although the agency thinks the number may significantly be higher. 


The infusion pumps are automated pumps that intravenously deliver drugs, food and other solutions to patients. They are used in hospitals and by patients at home.  The deaths involved individuals who had suffered accidental drug overdoses, either of because a hospital worker entered an incorrect dosage or because the software in the pump itself malfunctioned. 


Between 2005 and 2009, the FDA received more than 10,000 complaints about infusion pumps. In the same time period, infusion pump manufacturers issued 79 product recalls, the highest for any medical device. 


The FDA has said that manufacturers will soon be required to provide more data about their devices before sale and that the agency had determined that infusion pumps could be made much safer. Companies would also have to conduct limit clinical trial to ensure there were no faulty design elements, especially in the software of the devices.

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