25 October 2012

Smiths Medical gains FDA clearance for epidural safety system

Smiths Medical, a division of global technology business Smiths Group, announces that its advanced safety connector for injecting epidural medication has received clearance from the U.S. Food and Drug Administration (FDA).

The Portex® CorrectInject™ Safety System, designed to reduce the risk of potentially fatal tube misconnections, is the first safety system of its kind to receive a 510(k) clearance from the FDA. This allows it to be marketed in the US.

Smiths Medical President Srini Seshadri said: “As a global leader in safety medical devices, we are delighted to have developed an innovative solution to a long-standing and serious medication delivery issue. FDA clearance is a crucial component in our plans to roll out CorrectInject™ in major markets.”

Misconnections can occur because epidural, intravenous, enteral and other infusion lines are similar.  However, the connectors of the CorrectInject™ system are uniquely tapered and threaded to be incompatible with standard intravenous Luer connectors. Its bright yellow components also clearly indicate a neuraxial (spinal and epidural) delivery route. This further reduces the chances of confusing vein-delivered and neuraxial-delivered medication, an error which can cause death or serious illness.