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Bloodstream infections linked to positive displacement needleless connectors
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A potential connection between positive displacement needleless connectors and a rise in bloodstream infections has prompted the FDA to call for postmarket surveillance of the devices.
Agency officials said they based their results on a number of clinical studies that have noted an increase in bloodstream infections with the use of positive displacement needleless connectors in health care facilities.
The data have also suggested a subsequent decrease in infection after switching to other types of needleless connectors. The agency notes, however, 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.
The FDA said the following devices require 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).
Agency officials said postmarket studies should provide manufacturers with answers to the following public health questions:
- What is the rate of bloodstream infections for patients receiving a manufacturer's positive displacement connector for central line access and is it statistically noninferior to the rates seen in patients receiving other needleless connectors, such as negative, neutral or split-spectrum connectors, for central line access, given comparable patient populations?
- .Are there patient demographics, comorbidities or severity of illness, or device cleaning practices for which placement of your 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.
The 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."
Agency officials said patients and health care professionals should report adverse events to MedWatch. Previous research has demonstrated a correlation between cardiopulmonary bypass surgery and neurocognitive decline among infants undergoing surgery for complex congenital heart disease. However, according to researchers from The Children’s Hospital of Philadelphia, school-aged children undergoing surgery for acyanotic congenital heart disease did not experience significant neuropsychological complications after surgery.
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