What level of sterility is achieved by ArthroFLEX?

ArthroFLEX achieves a sterility level of 10-6, which indicates a very high degree of sterility where only one in a million products may be contaminated. This level is critical in surgical environments, especially within orthopedics and sports medicine, where the risk of infection must be minimized to ensure patient safety and enhance recovery outcomes.

The achievement of a 10-6 sterility assurance level means that the products are subjected to rigorous sterilization processes. This includes validated sterilization methods that effectively eliminate a wide range of microorganisms, making them suitable for use in sterile surgical procedures. For example, processes such as ethylene oxide gas or gamma radiation may be used to reach this high standard of sterility.

This level of assurance is particularly important when dealing with implantable devices or materials that will come into contact with sterile tissues within the body. In contrast, lower levels of sterility such as 10-3, 10-5, or 10-7 do not provide the same degree of confidence in the absence of contaminants, making them less suitable for critical surgical applications.