SOURCE: Ivera Medical Corporation

Ivera Medical Corporation

November 04, 2014 05:00 ET

Catheter Connections Fails Second Disinfection Test on Important Fungus, Announces Ivera Medical

SAN DIEGO, CA--(Marketwired - Nov 4, 2014) - Ivera Medical announced that an independent lab has found that the dark blue IV-Pole Strips and DualCap products for male luer connectors made by Catheter Connections failed in a second test to disinfect all critical surfaces of male luer connectors when used as directed on Candida albicans. Previously, results were published from an independent lab that found these same products failed to reach a 4-log reduction disinfection level on seven of the twelve samples inoculated with this common fungus. In this study, the Catheter Connections product failed to reach disinfection levels on all twelve of the samples tested. In order to promote transparency on this critical issue, the study report including the test protocol and related information for these tests can be found at www.curos.com.

"This second test on Candida, a significant fungus of concern for hospitals, raises continuing questions over the use of the Catheter Connections' product," said Bob Rogers, CEO of Ivera Medical. "Hospitals and patients alike need to understand the potential impact, based on these independent lab studies. The point of disinfecting is to ensure all of the critical areas of a device, in this case the distal end of a male luer, are disinfected. The findings of the independent lab in both tests of this fungus clearly demonstrate that disinfection is not consistently happening with the Catheter Connections product. Prior knowledge of these failures coupled with continued use should raise significant liability concerns."

In the same test, the Curos Tips product reached a 4-log reduction on all 12 samples tested, just as it has done on the prior tests. "These results are a red flag," said Mr. Rogers. "Although there might be other reasons for the products failing to properly disinfect, one obvious line of questioning is the fact their design prevents alcohol from coming into contact with the lumen of the male luer. Since this distal portion of the male luer is the most likely surface to be touched by skin or bed sheets, people should understand that the disinfection they are expecting might be compromised."

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