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FDA requires nine makers of needleless connectors to conduct post-market surveillance

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The U.S. Food & Drug Administration said it is requiring nine medical device companies to conduct postmarket analysis on a connection between needless connectors and higher rates of blood stream infections.

In a notice posted on the Centers for Devices and Radiological Health web site, officials said that the agency is “aware of information that raises concerns about the safety of positive displacement needleless connectors.”

The devices are intended to allow connections of multiple IV sets and catheter hubs without the use of needles and allow the “delivery of a wide range of fluids to a patient’s vascular system through a cannula inserted into a vein or artery,” according to the FDA.

However, the federal watchdog said it has received reports of three deaths associated with blood stream infections and positive displacement needleless connectors.

In addition, the agency said there have been several clinical reports since 2006 showing, “an association between the introduction of positive displacement needleless connectors into a hospital or unit and an increased rate of BSI, followed by a reduction in BSI after changing to another type of needleless connector.”

Companies asked to particpate in the study are Baxter Healthcare Inc.(NYSE:BAX), Amsino International, Inc., Becton Dickinson Infusion Therapy Systems Inc. (NYSE:BDX), B. Braun Medical Inc., Cardinal Health, LLC (NYSE:CAH), Carefusion, Inc. (NYSE:CFN), Critical Device Corporation, ICU Medical, Inc. (NSDQ:ICU) and Medegen Medical Manufacturing Services.

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