Alerts and Notices (Medical Devices) > Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication

Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication
Date Issued: August 11, 2010

Audience: Health Care Professionals

Medical Specialty: Infection Control

Summary of Issue and Scope:

Several peer-reviewed clinical studies report an increase in bloodstream infections following the introduction and use of positive displacement needleless connectors in healthcare facilities, as well as a reduction in infections after changing to another type of needleless connector. However, there is insufficient information to determine the magnitude of the risk of bloodstream infections with these devices as compared with other needleless connectors, or to determine whether the risk is associated with some or all positive displacement needless connectors. FDA is ordering post-market surveillance to better understand the risk of bloodstream infections from use of positive displacement needleless connectors.

Device:

A positive displacement needleless connector is part of a needleless system used for intravascular access. These devices may also be referred to as “luer activated valves,” “connectors,” or “accesses,” and may refer to “positive pressure” or “positive displacement” in their product descriptions.

Recommendations to Healthcare Professionals:

In 2008, two professional societies issued guidelines to minimize the risk of hospital acquired infections (http://www.journals.uchicago.edu/toc/iche/2008/29/S1). Those guidelines state, “Do not routinely use positive-pressure needleless connectors with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper use.” The FDA’s initial evaluation supports this recommendation.

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Alerts and Notices (Medical Devices) > Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication