Neutral-Pressure Needleless Connector Prevents Blood Reflux

A neutral-pressure connection device prevents all types of blood reflux in a catheter, and it can be used for the administration of blood and fluids to all patients, including pediatric and immune-compromised patients.

The Clave Neutron neutral-pressure needleless connector is a normally closed, bidirectional connector that incorporates a unique silicone valve within the fluid path. The valve prevents fluid displacement, both positive and negative at all times, including when the device is accessed. The device may also be used with power injector procedures up to 10 mL per second of contrast media and a maximum pressure of 2413 kPa. The device incorporates a pre-slit septum valve and internal cannulae, which are used to transfer fluid to the patient's catheter. The two functional components also prohibit bacterial transfer and bacterial ingress, as well as independently reduce catheter hub and tip bacterial colonization. The device also passively aids in the prevention of needle-stick injury, since needles cannot be introduced into the system during use.

The device incorporates a technology that prevents fluid displacement resulting from the connection or disconnection of a luer; from syringe plunger compression; from patient vascular pressure changes, such as coughing or sneezing; and from the intravenous (IV) solution container running dry. The Clave Neutron device is a product of ICU Medical (San Clemente, CA, USA), and has been approved by the U.S. Food and Drug Administration (FDA). The company expects to conduct expanded clinical beta testing of the device with select customers in the third quarter of 2010.

As a neutral-pressure device, the use of the Clave Neutron helps deal with concerns about the safety of positive displacement needleless connectors and their possible connection to higher rates of device associated bloodstream infections (BSI). Following three reports of deaths associated with BSI and positive displacement needleless connectors, the FDA ordered manufacturers of positive displacement connectors to conduct a post-market surveillance study on the safety of these devices.

Fluid displacement in syringe plunger rebound occurs when a flush has been done using a standard syringe; once the syringe is emptied, the clinician has the ability to compress the syringe plunger in an effort to infuse all available solutions, which once released by the clinician's hand, will rebound and cause negative fluid displacement.

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