Cardinal Health inks amended consent decree with FDA
This article was originally published in The Gray Sheet
Firm's amended consent decree with FDA expands its scope to include all Alaris infusion pumps, calling for the correction of good manufacturing practice violations. The pumps are made by a division of Cardinal Health formerly known as Alaris Medical Systems, which was acquired in 2004 and subject to the initial consent decree in February 2007 to resolve a 2006 seizure of Alaris SE infusion pumps (1"The Gray Sheet" Feb. 12, 2007, p. 5). FDA alleges in the amended consent decree that based on a January 2008 inspection, certain Cardinal Health infusion pumps do not satisfy agency standards, according to Cardinal. The firm says it implemented a new quality system in April 2008. Now the firm must hire an independent expert consultant to inspect all of its infusion pump facilities and recall procedures, and certify to FDA that corrective actions have been made. The amended decree, which includes the Alaris System, Gemini and Med System III infusion pumps, remains subject to approval by the U.S. District Court for the Southern District of California. If there are "future violations," FDA says it may suspend manufacturing and distribution
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CareFusion, which will soon spin off from parent firm Cardinal Health, is updating the software and directions for use for certain Alaris infusion pumps in a June 12 voluntary recall that FDA classified on Aug. 5 as Class I, the most serious category. Cardinal Health/CareFusion received 510(k) clearance for the software update in July and will provide it to customers within 60 days. Devices may have problems with pump warning messages, protection circuitry or components of the pumping mechanism that could lead to improper infusion therapy. In June, users were given risk mitigation steps to avoid overdosing until the software update arrives. CareFusion is setting aside $18 million for the corrective action, which could take a year to complete. Alaris pumps are currently subject to an FDA consent decree for manufacturing violations (1"The Gray Sheet" Feb. 23, 2009)
FDA has already completed three consent decrees blocking sales of medical devices in 2007, with two surfacing last week. The agency has not obtained more than two device-related injunctions in any of the previous six years
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