Focus on Safety:
Allowash XG®: The Gold Standard in Allograft Bio-Implant Sterility
In 1995, LifeNet Health pioneered a revolution in allograft bio–implant cleaning and disinfection with the introduction of a proprietary technology called Allowash®. Today, allograft tissue processed with LifeNet Health's patented Allowash XG® has a validated Sterility Assurance Level (SAL) of 10-6 — the same sterility level of medical devices. "That's no more than a single unit containing viable particles in a million units," says LifeNet Health Director of Scientific Affairs Mark Moore, Ph.D., who notes that other providers offer an SAL of just 10-3 which means as many as one in a thousand implants could be infected. LifeNet Health's remarkable safety record is proof that Allowash XG and other patented LifeNet Health processes make a difference. "To date, LifeNet Health has delivered over 2 million allograft bio-implants to healthcare providers and organizations nationwide without a single incident of disease transmission," says Dr. Moore.
LifeNet Health's approach to allograft bio-implant safety is comprehensive and ongoing. Once donor tissue has gone through a stringent screening routine and has been recovered in strict aseptic conditions, the tissue goes through additional microbiology testing to further control and eliminate incoming bioburden. All LifeNet Health allograft bio-implants are processed and preserved in facilities that maintain cleanliness levels that minimize environmentally-induced graft contamination. The bio-implants are cleaned with solutions that free tissue from over 99% of marrow and lipids and undergo a rigorous decontamination process that removes and eliminates viruses and bacteria. A controlled and validated dose of gamma irradiation administered at low temperatures after packaging produces an allograft bio-implant with an SAL of 10-6 with no compromise in vital biomechanical or biochemical properties.
"Allowash XG is just one of many patented processes engineered by LifeNet Health to ensure the safety, quality and effectiveness of our allograft bio-implant products," says Dr. Moore. "Ours is a standard of excellence that surgeons and healthcare providers around the country count on and we're committed to delivering."
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