Have I read this post three years ago, my immediate answer would have been “no”. My recent experience in the military, special with combat medic forces, has colored my perception. In a standard setting, where medical ressources are not scarce, FDA regulations should be implemented regarding the use of medical devices. However, as many pointed out above, certain regulations should be revised as to benefit patients who are terminally ill and left to die. Last semester, when doing some research into the evolution of BAK ( bioartificial Kidney) research, I came across some devices that didn’t fully met the FDA regulations but succeeded in prolonging ( by a few months) the life of some ESRD ( end-stage renal disease ) patients. However, the device was removed from the market as it began to be wrongfully used on non-terminal patients.
The context in which I have seen the most non-approved devices used in patients will have to be in combat environment. Medical care in those environments isn’t much concerned with FDA regulation, more than it is concerned with saving the life, leg, arm of the soldier at that very instant.