Excelsior Medical Inc. announces that it has received a new 510(k) clearance for its SwabCap luer access valve disinfection cap line of products. The new indication for use extends SwabCaps disinfection performance claim toÂ 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 toÂ seven days.
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 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 orÂ seven days, says 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 its being covered.
SwabCap is a sterile packaged disinfection cap designed to disinfect the top and threads of IV luer-lock needleless connectors with 70 percentÂ 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 toÂ seven days.
SwabFlushÂ® is the only device that 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 I.V. line.
SwabCap and SwabFlush have been the subject of numerous award-winning scientific presentations by independent clinician users. These include research presented at recent annual meetings of the Association for Vascular Access (AVA), Association for Professionals in Infection Control and Epidemiology (APIC), and the Children's Hospital Association (formerly NACHRI).
Source: Excelsior Medical Incorporated