The Food and Drug Administration has launched an infusion pump safety initiative aimed at addressing several serious and life-threatening problems reported to the agency in recent years. They include software defects, mechanical failure and inadequate user-interface designs.
FDA launches infusion pump safety initiative
According to FDA officials, 87 infusion pump recalls took place between 2005 and 2009, and the agency has received more than 56,000 reports of adverse events over the past five years in connection with infusion pumps. Those reports include more than 500 deaths.
As a part of the new safety effort, the FDA has issued new manufacturer draft guidance and has also sent a letter informing infusion pump devicemakers that they may need to conduct additional risk assessments to support approval of new or modified pumps. In the draft guidance, the agency recommended that manufacturers begin providing additional design and engineering information as a part of their premarket review applications for new infusion pumps.
The FDA will hold a public workshop May 25-26, 2010, to discuss ways to improve infusion pump safety.
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