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
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
Regardless of what business you’re in, it’s increasingly a software-driven business. Consumers’ rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge.” In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to o...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
For financial firms, the cloud is going to increasingly become a crucial part of dealing with customers over the next five years and beyond, particularly with the growing use and acceptance of virtual currencies. There are new data storage paradigms on the horizon that will deliver secure solutions for storing and moving sensitive financial data around the world without touching terrestrial networks. In his session at 20th Cloud Expo, Cliff Beek, President of Cloud Constellation Corporation, w...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that EARP Integration will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. EARP Integration is a passionate software house. Since its inception in 2009 the company successfully delivers smart solutions for cities and factories that start their digital transformation. EARP provides bespoke solutions like, for example, advanced enterprise portals, business intelligence systems an...
IBM helps FinTechs and financial services companies build and monetize cognitive-enabled financial services apps quickly and at scale. Hosted on IBM Bluemix, IBM’s platform builds in customer insights, regulatory compliance analytics and security to help reduce development time and testing. In his session at 20th Cloud Expo, Tom Eck, Industry Platforms CTO at IBM Cloud, will discuss how these tools simplify the time-consuming tasks of selection, mapping and data integration, allowing developers ...
SYS-CON Events announced today that Outscale, a global pure play Infrastructure as a Service provider and strategic partner of Dassault Systèmes, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2010, Outscale simplifies infrastructure complexities and boosts the business agility of its customers. Outscale delivers a secure, reliable and industrial strength solution for its customers, which in...
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs oft...
Interested in leveling up on your Cloud Foundry skills? Join IBM for Cloud Foundry Days on June 7 at Cloud Expo New York at the Javits Center in New York City. Cloud Foundry Days is a free half day educational conference and networking event. Come find out why Cloud Foundry is the industry's fastest-growing and most adopted cloud application platform.
In order to meet the rapidly changing demands of today’s customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
SYS-CON Events announced today that Cloud Academy will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud computing technologies. Ge...
When NSA's digital armory was leaked, it was only a matter of time before the code was morphed into a ransom seeking worm. This talk, designed for C-level attendees, demonstrates a Live Hack of a virtual environment to show the ease in which any average user can leverage these tools and infiltrate their network environment. This session will include an overview of the Shadbrokers NSA leak situation.