US-based Excelsior Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its SwabCap luer access valve disinfection cap line of products.
FDA approval of the SwabCap is based on the company's extended disinfection capabilities data demonstrating that SwabCap prevented the ingress of pathogens through the valve over the entire seven days it remained applied, when subjected to multiple microbial challenges of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Escherichia coli.
The company designed SwabCap, a sterile packaged disinfection cap, to disinfect the top and threads of IV luer-lock needleless connectors with 70% isopropyl alcohol when attached to the connector hub.
According to Excelsior Medical, SwabCap is the only disinfection cap with a 510(k) cleared indication for maintaining disinfection of the valve surface for up to seven days.
With its patented thread cover seal, SwabCap maintains a disinfected valve surface for up to seven days rather than just acting as a physical barrier.
Excelsior Medical CEO Steven Thornton said: "SwabCap goes beyond these indications with this new 510(k) cleared claim and provides nurses and physicians with a product that they can confidently use to disinfect the luer access valve the entire time it's being covered."
The company's SwabFlush device combines a saline flush syringe and disinfection cap. This combination helps improve compliance with disinfection protocols because the SwabCap is built into the syringe plunger, making it immediately and conveniently available to nurses after they flush an IV line.