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  • Dkonara921 replied to the topic Unapproved Device in the forum Introduction to Project Management 6 years, 7 months ago

    In case of an emergency, an unapproved medical device could be used if there is some enough that is has created positive results and has been tested in trials. As someone previously stated, there are about 4,000 patients each year that the FDA allows physicians to try unapproved devices or procedures. However, this is reserved for people who are terminal, meaning that they have no other option. Even though using an unapproved medical device could cause death in the patient, the reasoning is that either choice will mean death. The only difference is that using the unapproved medical device could perform a miracle and save the patient’s life or help extend his/her life by some amount of time. I personally believe that there should not be a limitation on the number of terminally- ill people who are allowed to try an unapproved device. If the patient gives consent and decides to take the risk of dying from the medical device than the illness, then it shouldn’t be an issue because if there is a small chance of working, meaning that symptoms have started to subside, then it would be better than nothing. Even if the medical device doesn’t work and the worst scenario happens, then we would know that it’s useless and that the device should be abandoned.