FDA Clears Alliance Medical's 510(k)s for Reprocessed Orthofix External Fixation Device and Aircast, Albahealth and KCI Compression Sleeves

PHOENIX -- The U.S. Food and Drug Administration (FDA) has cleared four additional 510(k)s for Alliance Medical Corporation's reprocessed medical devices, the company announced today. Alliance now adds Orthofix external fixation devices (K023714), Aircast compression sleeves (K021654), KCI (includes PlexiPulse) compression sleeves (K024087) and Albahealth Pulstar compression sleeves (K024074) to its growing line of devices that can be reprocessed. These four new clearances bring the total number of cleared 510(k)s for Alliance Medical to 26 and significantly expand the company's product offerings and ability to reduce supply costs for the nation's hospitals.

"Our customers continue to seek ways to eliminate unnecessary costs from their supply system while providing quality patient care," says Alliance CEO Rick Ferreira. "We know that many of our hospital customers reallocate the savings they generate through reprocessing to meet pressing patient care needs, such as community outreach programs, clinician salaries or the acquisition of the latest medical technologies. Our objective is to help our customers maximize their savings while maintaining quality patient care."

These clearances will allow Alliance to reprocess almost all available external fixation devices and compression sleeves. Previously, the company received FDA clearances for 510(k)s covering Howmedica, Synthes, Smith & Nephew Richards and EBI external fixation devices and Kendall, Huntleigh, ALP and Venodyne compression sleeves.

"Patient safety is always our first consideration when evaluating new products for reprocessing. As we reported in the recently cleared 510(k)s, our validated cleaning and sterilization procedures for the Orthofix external fixation devices achieved a 99.9 percent bioload reduction (log reduction of 4.6), qualitative LAL (Limulus amebocyte lysate) results of less than 13 EU per device and a sterility assurance level of 10 to the minus 6 power," states Don Selvey, Alliance's vice president of regulatory affairs and quality assurance. "To ensure functional integrity, the external fixation components were also subjected to fatigue testing using the FDA-recognized ASTM (American Society for Testing and Materials) F 1541-01 Standard Specification and Test Methods for External Skeletal Fixation Devices."

Selvey continues, "For the compression sleeves, comprehensive simulated clinical use studies were conducted before the device was inflated until it burst. The burst pressure was then statistically compared to that of new devices. Our engineers and independent labs found no evidence of material or functional degradation for any of the external fixation devices or the compression sleeves."

External fixation devices comprise specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used in orthopedic and reconstructive surgery to manage bone fractures. Compression sleeves reduce the incidence of deep vein thrombosis and resulting pulmonary embolism by supplying intermittent pressure to a patient's lower extremities. Together, these two devices can represent more than $500,000 in an average hospital's budget.

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.

Source: Alliance Medical Corporation