Excelsior Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its SwabCap luer access valve disinfection cap line of products.
This new indication for use extends SwabCap’s disinfection performance claim to seven days if not removed.
Excelsior Medical claims that it is the only disinfection cap in the market with a 510(k) cleared indication for maintaining disinfection of the valve surface for up to seven days.
Rather than just acting as a physical barrier, the SwabCap maintains a disinfected valve surface for up to seven days.
The FDA has approved SwabCap based on company’s extended disinfection capabilities data.
The data demonstrated that SwabCap, with its patented thread cover seal, 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.
Excelsior Medical CEO Steven Thornton noted all of the other disinfection caps on the market only have 510(k) cleared indications supporting a claim that they provide a barrier to potential pathogens for up to 96 hours or seven days.
"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," Thornton added.
SwabCap, a sterile packaged disinfection cap, has been designed by Excelsior Medical to disinfect the top and threads of IV luer-lock needleless connectors with 70% isopropyl alcohol when attached to the connector hub.
Excelsior Medical’s SwabFlush 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 I.V. line.