|By Marketwired .||
|September 3, 2014 05:00 AM EDT||
SAN DIEGO, CA -- (Marketwired) -- 09/03/14 -- A second independent lab test provided further evidence that the Catheter Connections DualCap products for male luers fail to consistently disinfect the tip of the male luer connector. Ivera Medical sued Catheter Connections for false advertising and unfair competition last week based on false claims that its dark blue IV-Pole Strips and DualCap products for male luer connectors disinfect all critical surfaces of male luer connectors when used as directed.
As with the first study, the study protocol and complete results are available to the public at www.curos.com. The testing protocol developed by the independent laboratory included inoculating the surface of the tip of the male luer with Staphylococcus aureus. Ivera's Curos Tips and Catheter Connections' DualCap Dark Blue male disinfection caps were then used on the inoculated male luer connectors in accordance with the instructions for use for each device. Performance was measured against the clinical claims of the product, as stated in publicly available FDA 510(k) documents. Accordingly, a 5-minute dwell time was used for the Catheter Connections cap and a 3-minute dwell time was used for Curos Tips.
As previously reported, DualCap failed to reach disinfection levels (a 4-log reduction in organisms) in 7 of 12 samples in the first set of tests. In this second test, Dual Cap failed to reach disinfection levels in 5 of 12 samples. Despite its significantly shorter dwell time, Ivera's Curos Tips far exceeded the disinfection levels on all 24 samples.
"As we further study these results, we see multiple issues that could be impacting their performance," said Bob Rogers, CEO of Ivera Medical. "Catheter Connections issued a press release trying to explain away the results from the first test, but did not address key concerns, such as the occlusion of the lumen of the male luer. These two independent lab tests seem to indicate that DualCap does not get alcohol to the surface most likely to be contaminated, the tip of the male luer. While we have posted the test protocol online for anyone to duplicate, they have offered no details regarding their own test protocols that they used to get DualCap on the market. Instead of hiding behind private protocols, Catheter Connections has a basic question to answer: Is it not important to disinfect the entire luer connection, including the tip?"
About Ivera Medical
Ivera Medical Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing and sale of products that help healthcare providers reduce facility-acquired patient infections. Curos, manufactured in Carlsbad, CA, is the first disinfecting cap to be marketed in the U.S. and has received FDA's 510(k) market clearance. For more information about Curos and Ivera Medical, visit the website at www.curos.com