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:Alliance Medical Adds Chest Retractors, Heart Positioners and Tissue Stabilizers to its Reprocessing Product List; Develops a New Milestone in Device-Cleaning Technology
@bopdy:PHOENIX -- Mindful of the need to help hospitals control soaring medical device costs, Alliance Medical Corporation announced today that it has developed UltraClean-6, an innovative, proprietary cleaning technology that makes it possible to reprocess chest retractors, heart positioners and tissue stabilizers. Utilizing this new technology, Alliance estimates that it will reprocess at least 3,000 units during the first year, saving hospitals more than $2 million, or between $400 and $700 per OPCAB (Off-Pump Coronary Artery Bypass) procedure.
"Reprocessing these costly devices supports Alliance's goal of safely reducing supply costs for our hospital partners," explains Alliance CEO Rick Ferreira. "We will continue to seek additional savings opportunities for our customers by maximizing the collection of these devices and by determining what other expensive devices can be reprocessed now that we can clean devices using our new UltraClean-6 technology."
Alliance will reprocess the following systems:
Medtronic Octopusr System II: Octopusr 4 Tissue Stabilizer and Starfish 2 Heart Positioner;
Guidant: Integrated Cardiac Stabilization-Positioning System;
Genzyme Immobilizer: Cardiac Stabilization System.
Reprocessing these devices will save hospitals approximately 50 percent over the cost of purchasing replacements from the original manufacturers. These devices are used during beating heart bypass surgery to stabilize and position the heart.
"Our facility currently uses the Genzyme system, and we plan to start reprocessing this expensive device immediately," says Fran Byrne, director of perioperative services at Salt Lake Regional Medical Center in Salt Lake City, Utah. "Reprocessing makes sense because it safely reduces our annual supply costs. Also, reprocessing can actually improve patient care because the savings it provides can be re-allocated to purchase new medical technologies or fund vital patient care services that are being financially squeezed and could face cuts. We also appreciate the environmental benefits reprocessing offers by reducing the burden on our landfills."
"Extensive testing and re-testing by Alliance engineers and independent national laboratories validates that any Alliance-reprocessed chest retractor, heart positioner or tissue stabilizer returned to a hospital will be clean, sterile, pyrogen-free and perfectly ready for another use," according to Don Selvey, Alliance's vice-president of regulatory affairs and quality assurance. "Our validated cleaning and sterilization procedures, which include our new UltraClean-6 multi-step process that incorporates ultrasonic and effervescent washes, achieve a bioload reduction of 99.9 percent, qualitative LAL levels of 4.5 EU per device and a sterility assurance level of 10-6, without material degradation or impairment to the device," Selvey explains.
Alliance engineers also designed and manufactured a customized drying chamber, since none of the existing equipment met their rigorous specifications. The new, proprietary chamber uses heated air circulating at 200 cubic feet a minute, resulting in 25 air replacement cycles a minute.
Although the Food and Drug Administration (FDA) currently classifies chest retractors, heart positioners and tissue stabilizers as Class I devices, Alliance followed the same scientific testing and validation processes it uses for approving Class II devices that require a 510(k) submission.
Alliance Medical Corporation is a leading reprocessor of specific single-use medical devices (SUDs). Alliance, and its predecessor companies, has safely reprocessed more than 7 million SUDs, saving hospitals and surgery centers in excess of $75 million. The company's services focus on reducing supply 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.