Post-market surveillance studies for the MaxPlus® needle less connectors completed

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CareFusion report “CareFusion, a leading global medical technology company, today announced the U.S. Food and Drug Administration (FDA) has notified the company that it has fully completed its obligations for Post-market Surveillance Studies for the MaxPlus® line of positive displacement needleless connectors.

In an Aug. 6 letter to CareFusion, FDA officials cited multiple studies conducted by CareFusion that showed MaxPlus positive displacement needleless connectors had no evidence of higher infection rates as compared to other neutral or negative displacement needleless connectors. The letter highlighted an analysis of the CMS’ Hospital Compare database suggesting that in 2013, hospitals using MaxPlus positive displacement needleless connectors had lower unadjusted central line associated blood stream infection (CLABSI) rates, as well as lower standardized infection ratios, compared to hospitals not using MaxPlus. These assessments were based on data from 3,074 hospitals, accounting for nearly 11,000 CLABSIs associated with approximately 10 million catheter days.”

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