01.14.14
Neptune, N.J.-based Excelsior Medical Inc. has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Swabcap luer access valve disinfection cap line of products. The new indication for use extends Swabcap’s disinfection performance claim to 7 days if not removed and provides the market with the only disinfection cap with a 510(k) cleared indication for maintaining disinfection of the valve surface for up to 7 days.
In order to provide healthcare institutions with the confidence that the Swabcap actually maintains a disinfected valve surface for up to 7 days rather than just acting as a physical barrier, Excelsior developed and filed extended disinfection capabilities data with the FDA to support this claim. This additional data reportedly demonstrated that Swabcap, with its patented thread cover seal, prevented the ingress of pathogens through the valve over the entire 7 days it remained applied, when subjected to multiple microbial challenges of staphylococcus aureus, staphylococcus epidermidis, pseudomonas aeruginosa, and Escherichia coli.
“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 7 days,” said Steven Thornton, CEO of Excelsior Medical. “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.”
Swabcap is a sterile packaged disinfection cap designed to disinfect the top and threads of intravenous (IV) luer-lock needleless connectors with 70 percent isopropyl alcohol when attached to the connector hub. Caregivers luer-lock Swabcap on the connector aseptically and leave it in place between line accesses to disinfect the connector and maintain a disinfected valve surface for up to 7 days.
Swabflush, a device that combines a saline flush syringe and disinfection cap, is meant to be combined with Swabcap. This combination is designed to help improve compliance with disinfection protocols because the Swabcap is built into the syringe plunger, making it immediately available to nurses after they flush an IV line.
Excelsior Medical makes catheter maintenance products to improve disinfection and may reduce medication errors and healthcare costs.
In order to provide healthcare institutions with the confidence that the Swabcap actually maintains a disinfected valve surface for up to 7 days rather than just acting as a physical barrier, Excelsior developed and filed extended disinfection capabilities data with the FDA to support this claim. This additional data reportedly demonstrated that Swabcap, with its patented thread cover seal, prevented the ingress of pathogens through the valve over the entire 7 days it remained applied, when subjected to multiple microbial challenges of staphylococcus aureus, staphylococcus epidermidis, pseudomonas aeruginosa, and Escherichia coli.
“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 7 days,” said Steven Thornton, CEO of Excelsior Medical. “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.”
Swabcap is a sterile packaged disinfection cap designed to disinfect the top and threads of intravenous (IV) luer-lock needleless connectors with 70 percent isopropyl alcohol when attached to the connector hub. Caregivers luer-lock Swabcap on the connector aseptically and leave it in place between line accesses to disinfect the connector and maintain a disinfected valve surface for up to 7 days.
Swabflush, a device that combines a saline flush syringe and disinfection cap, is meant to be combined with Swabcap. This combination is designed to help improve compliance with disinfection protocols because the Swabcap is built into the syringe plunger, making it immediately available to nurses after they flush an IV line.
Excelsior Medical makes catheter maintenance products to improve disinfection and may reduce medication errors and healthcare costs.