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Exactech Inc. Message Board

  • falascoj falascoj Dec 24, 2013 11:00 AM Flag

    Way To Get Quality

    Many people undergo implant procedures every year but how many of you know that the implant you are getting was most likely never run
    through any type of quality control. Yes I was shocked to learn that while there is legislation to cover everything from toxic spills to banned
    words over the airways the FDA 510 -(K) process medical implant device manufacturers are mandated by only requires "best practices" be followed in the quality control of parts. What does that mean exactly ? Seems it means that the manufactures would rather set up lawsuit reserves to pay out on the thousands of claims that are floating through our courts today. What can be done ? One approach might be for
    implant patients to ask their medical team to provide an audit that the parts being placed in your body have been checked within the
    design tolerances they were intended for . My question to the community is what amount would you pay for this service ? We get extended coverage on the cars,big screen TV's,and smart phones we buy . It would be very easy to manage this process through having your implant
    parts checked out by a service bureau that would use automated robotic 3D imaging techniques to provide not only quality statistics but
    images of the parts you will be getting .

    Sentiment: Buy

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