Welcome!

News Feed Item

Ivera Medical Files Suit Against Catheter Connections After DualCap Product Fails to Disinfect in Independent Study

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

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
No hype cycles or predictions of zillions of things here. IoT is big. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, Associate Partner at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He discussed the evaluation of communication standards and IoT messaging protocols, data analytics considerations, edge-to-cloud tec...
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Announcing Poland #DigitalTransformation Pavilion
Digital Transformation is much more than a buzzword. The radical shift to digital mechanisms for almost every process is evident across all industries and verticals. This is often especially true in financial services, where the legacy environment is many times unable to keep up with the rapidly shifting demands of the consumer. The constant pressure to provide complete, omnichannel delivery of customer-facing solutions to meet both regulatory and customer demands is putting enormous pressure on...
CloudEXPO | DXWorldEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
DXWorldEXPO LLC announced today that All in Mobile, a mobile app development company from Poland, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. All In Mobile is a mobile app development company from Poland. Since 2014, they maintain passion for developing mobile applications for enterprises and startups worldwide.
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
For far too long technology teams have lived in siloes. Not only physical siloes, but cultural siloes pushed by competing objectives. This includes informational siloes where business users require one set of data and tech teams require different data. DevOps intends to bridge these gaps to make tech driven operations more aligned and efficient.
The best way to leverage your CloudEXPO | DXWorldEXPO presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering CloudEXPO | DXWorldEXPO will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at CloudEXPO. Product announcements during our show provide your company with the most reach through our targeted audienc...
Everything run by electricity will eventually be connected to the Internet. Get ahead of the Internet of Things revolution. In his session at @ThingsExpo, Akvelon expert and IoT industry leader Sergey Grebnov provided an educational dive into the world of managing your home, workplace and all the devices they contain with the power of machine-based AI and intelligent Bot services for a completely streamlined experience.
@DevOpsSummit at Cloud Expo, taking place November 12-13 in New York City, NY, is co-located with 22nd international CloudEXPO | first international DXWorldEXPO and will feature technical sessions from a rock star conference faculty and the leading industry players in the world.
DXWorldEXPO | CloudEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, @CloudEXPO and DXWorldEXPO are two of the most important technology events of the year. Since its launch over eight years ago, @CloudEXPO and DXWorldEXPO have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors!
22nd International Cloud Expo, taking place June 5-7, 2018, at the Javits Center in New York City, NY, and co-located with the 1st DXWorld Expo will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud ...
Dhiraj Sehgal works in Delphix's product and solution organization. His focus has been DevOps, DataOps, private cloud and datacenters customers, technologies and products. He has wealth of experience in cloud focused and virtualized technologies ranging from compute, networking to storage. He has spoken at Cloud Expo for last 3 years now in New York and Santa Clara.