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CareFusion announces that the 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.
“We have always believed in the design of the MaxPlus needleless connector,” says Jim Paloyan, vice president of Americas Infusion Specialty Disposables for CareFusion. “The data from nearly 10 million catheter days suggesting lower infection rates for hospitals using MaxPlus are a powerful testament to the design and function of our product.”
All manufacturers of positive displacement connectors were required by the FDA to perform post-market surveillance. Manufacturers were asked to provide data to show that the rate of bloodstream infections for patients receiving a positive displacement needleless connector for central line access is statistically non-inferior to the rates seen in subjects receiving other needleless connectors for central line access, given comparable patient populations. Through the completion of this study, CareFusion has no further post-market surveillance requirements from the FDA concerning the MaxPlus needleless connector.
Source: CareFusion Corporation