|By Marketwired .||
|August 27, 2014 05:00 AM EDT||
SAN DIEGO, CA -- (Marketwired) -- 08/27/14 -- Ivera Medical announced that it has sued Catheter Connections for false advertising and unfair competition 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. Testing conducted by an independent laboratory indicates that Catheter Connections' dark blue disinfecting caps for male luer connectors fail to consistently meet minimum standards for disinfecting devices, and are inferior to Curos Tips in disinfection performance. The study report and related information can be found at www.curos.com.
"These results are not surprising, given the design of the Catheter Connections' product and its place of manufacture," said Bob Rogers, CEO of Ivera Medical. "To speculate on a single reason for their disinfection failure would be a mistake, as there are many possible reasons. One possible reason is their design may prevent alcohol from coming into contact with the portion of a male luer connector most likely to be contaminated, its tip. Ironically, the company has touted this as a strength of its design, but this independent study proves otherwise. Another possible reason may be that some of the components and assemblies used in Catheter Connections' products are made in China, and appear to be of inconsistent quality. Other possible factors include the use of significantly less alcohol than we use in our Curos Tips. We are analyzing the test results and evaluating their design further to assess other potential reasons the Catheter Connections product failed to disinfect in accordance with its claims."
The testing protocol developed by the independent laboratory included inoculating the surface of the tip of the male luer with Staphylococcus aureus. Curos Tips and the Catheter Connections DualCap Dark Blue Male Disinfection Cap 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.
The independent laboratory found that the Catheter Connections cap did not consistently meet basic disinfection standards requiring a 4 Log reduction on one of the most important microorganisms, Staphylococcus aureus, a bacteria implicated in a wide variety of healthcare challenges. Despite a significantly shorter dwell time, Curos Tips exceeded the disinfection requirements, confirming that Curos Tips puts the alcohol where it is needed to be effective. The actual test results may be found at www.curos.com.
Mr. Rogers noted that "Two key questions arise from these findings. The first question is how did Catheter Connections obtain FDA 510(k) clearance for this device as a disinfection product? I speculate that the results Catheter Connections would have had to provide to the FDA were the results of disinfection tests conducted by only inoculating the exterior portion of male luers away from the point most likely to be contaminated, the exposed tip of the post. Second, it is known some or all of Catheter Connections' products or components are manufactured in China. How does Catheter Connections certify the quality of the components, including the IPA used?"
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
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