Alliance Medical Corporation announced that the Food and Drug Administration (FDA) has cleared Alliance's 510(k) (K030109) for additional Cordis Webster IVC unipolar and fixed curve electrophysiology (EP) catheters and cables. Alliance can now reprocess almost all unique models of diagnostic EP catheters from all major manufacturers, far more than any other third-party reprocessor.
"The nation's hospitals are seeking prudent solutions to address rising supply costs, and they want their reprocessing partner to possess the industry's most extensive reprocessing list of high-cost, high-volume medical devices that provide significant, recurring savings," explains Alliance CEO Rick Ferreira. "Alliance Medical Corporation has met this challenge with our industry-leading 28 FDA-cleared 510(k)s that cover the most in-depth roster of medical device model numbers in the industry. We will continue to develop new 510(k)s for devices that hospitals want to reprocess that can meet our stringent validation standards."
Reprocessing diagnostic EP catheters reduces the cost of an EP study an average of $300 to $500. This safely saves hospitals with EP labs that perform 1,000 or more studies annually between $250,000 to more than $1 million a year.
Alliance subjected the EP catheters covered in the 510(k) to 15 functional tests -- nine electrical and six mechanical -- to ensure that the reprocessed devices perform in the same manner as original devices. The results of these comprehensive, rigorous tests determined that the EP catheters and cables can be safely reprocessed up to six times. In addition to testing for functionality, Alliance engineers and independent national laboratories performed extensive testing and re-testing to validate that these reprocessed Cordis Webster IVC EP catheters and cables will be clean, sterile and pyrogen free when they are returned to hospitals.