FDA Clears Excelsior Medical’s Disinfection Cap

Excelsior Medical Inc. has received a new U.S. Food and Drug Administration (FDA) 510(k) clearance for its SwabCap luer access valve disinfection cap line of products. The new indication for use extends SwabCap’s disinfection performance claim to seven 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 seven days.

To provide healthcare institutions with a SwabCap that maintains a disinfected valve surface for up to seven 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 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.

“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,” 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 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 IV luer-lock needleless connectors with 70 percent isopropyl alcohol when attached to the connector hub. Caregivers simply 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 seven days.

SwabFlush combines a saline flush syringe and disinfection cap. This combination is designed to help 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 intravenous line.

Excelsior Medical Corporation is a privately held medical device company with a primary focus on innovative catheter maintenance products that improve disinfection and may reduce medication errors and healthcare costs. The Neptune, N.J., company manufactures and sells SwabCap and SwabFlush for the disinfection and protection of IV needleless connectors. Formed in 1989, Excelsior also manufactures and sells prefilled saline flush syringes, prefilled heparin flush and lock syringes, and syringe pump systems.