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.
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.
Postmarket Surveillance Studies
FDA is requiring companies that manufacture positive displacement needleless connectors to conduct postmarket surveillance studies. The studies will help clarify the infection risk associated with these devices and define more precisely their risks and benefits. Manufacturers will be required to collect data on bloodstream infections in patients who received their devices compared to patients who received other types of needleless connectors. More details can be found in FDA’s letter to infection control professionals.
Reporting Problems to FDA:
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with the use of positive displacement needleless connectors, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements should follow the reporting procedures established by their facilities.
Health care providers are also encouraged to notify their facility’s infection control personnel if they suspect a positive displacement needleless connector contributed to a bloodstream infection.
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV or 800-638-2041.
This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.