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Focus on Safety:
LifeNet Health Follows Stringent AAMI Guidelines on Sterility
Sterility is defined as the complete absence of living microorganisms. Since proving complete freedom from contamination on each individual graft is not feasible, the likelihood of a product being sterile is expressed in terms of the probability of a microorganism surviving a sterilization process. The Sterility Assurance Level (or SAL) of a product is defined as the probability of any given unit being non-sterile after exposure to a validated sterilization process. SAL is, therefore, a measure of confidence in the attainment of sterility.
In guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI), invasive and surgically implantved medical devices should have a Sterility Assurance Level of at least 10-6. The United States Pharmacopeia (USP) establishes in their standards that a sterility assurance level (SAL) of 10-3 is comparable to the microbial survivor probability of aseptically produced products and is a level similar to the overall efficiency of an aseptic operation. Whereas a 10-3 SAL provides a probability of one viable microorganism in a thousand units, products with a 10-6 SAL will have no more than a single viable particle in a million units. Consequently, the lower the SAL, the greater is the assurance of sterility. Read more…
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Focus on Quality:
Peroneus Longus and Posterior Tibialis Bio-Implants in Knee Reconstruction
Human tendon allografts have been used in clinical sports medicine applications for more than two decades. In particular, reconstruction of the anterior cruciate ligament (ACL) is one of the most common soft tissue reconstructive procedures in orthopedic practice. Human allograft tissue offers several distinct advantages over autografts including shorter operative times, reduced surgical morbidity, decreased postoperative pain and improved cosmesis. Also, recent advances in terminal sterilization technologies virtually eliminate the risk of disease transmission while maintaining clinically relevant properties.Read more…
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Focus on Service:
CEU Program for Burn Applications Now Available
LifeNet Health introduces Exploring Severe Burn Wounds: Allografts – The First Line of Defense, a 1-credit CEU program now available for perioperative nurses, surgical technologists and other healthcare personnel who are responsible for burn patient care. Burns are extremely painful and challenging to treat. Skin allografts from donors are widely used in the treatment of burn injuries.
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Focus on Innovation:
LifeNet Health Introduces New Product: Oracell™ Decellularized Dermis for Dental and Maxillofacial Applications available November 1, 2010
Oracell™ is an acellular dermal matrix intended to be used in conjunction with guided tissue and bone regeneration, and oral soft tissue correction. MATRACELL™, a patented and validated technology by LifeNet Health, renders Oracell allograft dermis acellular without compromising biomechanical or biological properties.
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