Bloodstream Infections Linked to Needleless Connectors

The FDA is investigating a potential connection between positive displacement needleless connectors and a rise in bloodstream infections.

The findings, which have prompted the agency to call for postmarket surveillance of the devices, are based on a number of clinical studies. Along with an increase in bloodstream infections with the use of positive displacement needleless connectors in healthcare facilities, the data have also suggested a subsequent decrease in infection after switching to other types of needleless connectors.

The FDA, however, notes that current information is not yet sufficient to determine the risk for developing device-associated infection and whether all needleless connectors or just certain types cause this problem.

According to a report in Infectious Disease News, the agency has identified the following devices as requiring postmarket surveillance:

• Cortez Needle Free IV Connector (Amsino International)
• IV/Catheter Extension Set with NAC Plus Needleless Access Connector and NAC Plus Needleless Connector (Baxter Healthcare)
• BD posiflowTM Positive Displacement Valve (Becton Dickinson Infusion Therapy Systems).
• Ultrasite Valve (B. Braun Medical)
• IVAC Needle Free Administration Sets (Cardinal Health 200)
• SmartSite Needle Free Valve Administration Sets (Carefusion 303)
• NIMA Needleless Injectionsite Master Adapter with PosiFlow Positive Displacement Feature, and IV Sets (Critical Device)
• CLC2000 Catheter Patency Device (ICU Medical)
• MaxPlus Tru-Swab Positive Displacement Connector (Medegen Medical Manufacturing System).
• TEGO (ICU Medical)

Through postmarket studies, manufacturers are aiming to be able to determine the rate of bloodstream infections for patients receiving a positive displacement connector for central line access, and whether the rate is statistically noninferior to those seen in patients receiving other needleless connectors, such as negative, neutral or split-spectrum connectors, for central line access, given comparable patient populations.

They should also be able to establish whether there are patient demographics, comorbidities or severity of illness, or device cleaning practices for which placement of the positive displacement connector for central line access increases patients' risk of bloodstream infections compared with other needleless connectors.

The FDA noted that these studies could take up to 3 years to complete, and after each study concludes, the agency will evaluate the potential need for action. The FDA also recommends continued adherence to guidelines established by the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America.

For more information:

• American Journal of Managed Care—Screening Cardiac Surgery Patients for MRSA: An Economic Computer Model
• Nurses’ Guidelines Dramatically Reduce Bloodstream Infections in the Oncology Unit
• CDC—The Impact of Hospital-Acquired Bloodstream Infections