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PHOENIX -- Alliance Medical Corporation announces Food and Drug Administration (FDA) clearance of two additional Alliance 510(k)s for electrophysiology (EP) catheters and cables. Alliance now has 31 cleared 510(k) submissions for reprocessed medical devices.
CR Bard Deflectable Tip EP catheters and cables (K030187) and Medtronic Marinr and StableMapr EP catheters and cables (K030279) now join Alliance's broad product offering of reprocessed single use devices (SUDs) available to hospitals and labs. This extensive listing reflects the largest registry of EP catheter and cable models, including EP products from the industry's leading manufacturers: C.R. Bard, Daig, EP Technologies, Medtronic and Biosense Webster (Cordis Webster).
According to Alliance CEO Rick Ferreira, "As the premier reprocessor, we have made a corporate commitment to take ownership of the EP reprocessing market space and bring further value to our hospital and lab customers. Reprocessing represents a clear opportunity for dramatic supply cost reduction, while at the same time ensuring the safety and efficacy of these devices and other SUDs."
Adhering to stringent FDA standards, which are identical to those required of original equipment manufacturers (OEMs), Alliance conducted bench and laboratory testing to demonstrate performance (safety and effectiveness) of the reprocessed EP catheters.
"Alliance safety assurance testing included biocompatibility and material characterization analysis, validation of cleanliness, sterilization validation, and functional integrity verification," explains Don Selvey, Alliance's vice president of regulatory affairs and quality assurance. "The results of Alliance's rigorous testing on the reprocessed SUDs mirrored performance ratings of new devices. Alliance's 510(k)s also included scientific data to support the company's ability to safely reprocess these EP catheters and cables up to six times."
During routine reprocessing, Alliance technicians and quality control inspectors examine and test every device at multiple points during reprocessing to ensure that each will perform as intended. They reject any device that does not pass every inspection and test.
Ferreira asserts that reprocessing diagnostic EP catheters represents an average savings of $300 to $500 per EP study, freeing up resources that can be allocated to other areas throughout the hospital enterprise including patient care, staff, research or equipment.
"The potential savings are dramatic -- EP labs that perform 1,000 or more studies annually can expect to save from $250,000 up to $1M or more each year. In these times of extreme fiscal oversight, these monies can make a substantial bottom-line difference and impact overall operations," concludes Ferreira.
Alliance Medical Corporation is a leading reprocessor of specific single-use medical devices (SUDs). Alliance has safely reprocessed more than 11 million SUDs, saving hospitals and surgery centers in excess of $125 million. The company's services focus on reducing supply chain costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance's unique AIM (Assessment, Implementation and Management) program uses clinical implementation teams to provide facilities with the tools needed to maximize their savings from reprocessing.
Source: Alliance Medical