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Catheter Connections announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application that broadly covers a method of disinfecting IV tubing end connectors. Upon issuance, the patent will expire no earlier than 2029. A family of corresponding patent applications is pending in the U.S. and internationally.
Landmark clinical evidence shows that the IV tubing end connector (a male “luer lock” connector) is susceptible to microbial contamination and routinely causes cross-contamination between IV connectors. Studies also confirm that biofilm, which is responsible for the majority of blood stream infections, forms on these connectors and that a contaminated connector will transfer microbes into a patient’s IV catheter. The Company is now selling DualCap, the only FDA-cleared device for disinfection and protection of both the IV catheter needleless luer access valve and the IV tubing end connector.
Catheter Connections was the first to recognize and demonstrate that the IV tubing end connector is a vector of microbial contamination and is a significant risk factor for hospital-acquired infections. “This patent issuance is particularly valuable because it confirms that we were the first to innovate a medical device solution unlike any other. It further protects the platform technology underlying the Company’s DualCap System and is an indicator of the dominant position we expect to achieve worldwide,” said Vicki Farrar, Esq., CEO of Catheter Connections.
Each year more than 500,000 patients in U.S. hospitals suffer from IV catheter-related blood stream infections and up to one in four patients die as a result. Due to the preventability of these infections, insurers no longer reimburse hospitals for treating them, costing hospitals up to $11 billion annually; hospitals lose an average of $47,000 per infection.
The traditional method of disinfecting IV access valves using an alcohol swab to scrub the valve surface, currently in place at the majority of U.S. hospitals, is insufficient. This method does not disinfect the IV tubing end connector. Even if valves are scrubbed, the variability in scrubbing technique among clinicians leads to inconsistent valve disinfection. The DualCap System is the only integrated solution that addresses these deficiencies.