Excelsior medical's SwabFlush receives FDA 510(k) clearance

Mar 8 2011

Excelsior Medical Corporation announced today that it has received FDA 510(k) clearance for SwabFlush™, its latest product for the vascular access and infection control markets.

SwabFlush is the only IV catheter flush syringe that provides a disinfection cap for needleless IV connectors, built into the plunger of the syringe.

“Hospitals all over the country have been frustrated by their inability to monitor compliance with their valve disinfection protocols”

The all-in-one combination of SwabCap® and Excelsior's ZR™ pre-filled flush syringe promotes compliance with required protocols for both catheter flushing and disinfection of IV connectors.

SwabFlush allows a nurse who has accessed an IV catheter line in order to deliver medication to the patient to complete the access, and then use the two SwabFlush components (saline flush syringe and SwabCap) to flush the line and cap it. SwabFlush replaces the final saline flush syringe.

SwabFlush includes a 10mL flush syringe pre-filled with 3 ml, 5 ml or 10mL of saline.

"Hospitals all over the country have been frustrated by their inability to monitor compliance with their valve disinfection protocols," said Bill Rice, Excelsior's President and CEO. "SwabFlush addresses the problem by incorporating valve disinfection with flushing -- making it easier and more convenient to flush, disinfect and protect the valve all at the same time. This enhances compliance and saves nursing time." Rice said Excelsior Medical will begin shipping SwabFlush to customer sites by May.

SwabCap is a simple twist-on device that disinfects swabable IV connectors (also known as injection ports and luer access valves) between line accesses. The FDA-cleared device passively disinfects the catheter valve top and threads while providing a physical barrier to contamination. The cap helps verify compliance with clinical protocols for disinfecting IV connectors -- including The Joint Commission's National Patient Safety Goal (NPSG.07.04.01) that requires use of a standardized protocol to disinfect injection ports prior to access.

Clinicians presenting scientific evidence at professional conferences have reported excellent cost and clinical outcomes with SwabCap. The results of the first large clinical study on this technology will be presented by independent researchers at the annual conference of the Society for Healthcare Epidemiology of America (SHEA), which is April 1 to 4 in Dallas.

SwabCap® disinfects IV connectors by bathing the valve's threads and top with 70% isopropyl alcohol. As the cap is twisted onto the threads, a foam pad inside the cap is compressed, releasing the alcohol. The twisting action and the patent-pending thread cover design help focus the alcohol on the targeted areas. The cap also acts as a physical barrier to touch and airborne contamination, providing continuous disinfection for up to 96 hours under normal conditions.

ZR Syringes use technology designed to minimize syringe-generated reflux, which is one of the causes of catheter occlusions, a complication of long-term catheter use. Both SwabCap and ZR Syringes are terminally sterilized for increased patient safety.