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CareFusion Announces Completion Of Post-Market Surveillance For MaxPlus® Positive Displacement Needleless Connectors

Data from CMS Hospital Compare database showing hospitals using MaxPlus® had lower infection rates compared to hospitals not using MaxPlus

Sep 4, 2014

SAN DIEGO, Sept. 4, 2014 – CareFusion (NYSE:CFN), 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.

“We have always believed in the design of the MaxPlus needleless connector,” said 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.

About CareFusion Corporation
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops industry-leading technologies including Alaris® infusion pumps and IV sets, MaxPlus® and MaxZero IV connectors and sets, Pyxis® automated dispensing and patient identification systems, AVEA®, LTV® series and AirLife® ventilation and respiratory products, ChloraPrep® products, MedMined® services for data mining surveillance, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs approximately 15,000 people across its global operations. More information may be found at www.carefusion.com.

 

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For further information: Media: Troy Kirkpatrick, (858) 617-2361, troy.kirkpatrick@carefusion.com or Investors: Jim Mazzola, (858) 617-1203, jim.mazzola@carefusion.com