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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.
Although current regulations do not require tissue banks to use processing methods that guarantee tissue sterility, LifeNet Health has adopted the stringent AAMI guidelines recommending a Sterility Assurance Level of at least 10-6.
Numerous sterilants and sterilant combinations are used to eradicate microorganisms on allograft tissues. These include chemical sterilants, gas plasma, ethylene oxide (EO), gamma radiation, and e-beam radiation. Sterilization systems such as LifeNet Health’s Allowash XG®, which utilizes a controlled-dose, low-temperature gamma irradiation approach to eradicate microbes and viruses while preserving biomechanical integrity and function of allograft tissue necessary for surgical applications.
For more information on the Allowash XG process, please click here.
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