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Are 510(k)s Overused?

As part of its ongoing series, “The Evidence Gap” The New York Times is calling out the use (or overuse) of 510(k)s in getting devices to market. The article does raise some interesting points, namely that the short lead time of 510(k)s was meant to be a stop-gap measure when FDA first began regulating devices.

Now, however, it is the most popular form FDA receives by a margin of thousands. However, author Reed Abelson seems to be forwarding a theory of mass conspiracy against patients, to fool them into using medical technology that does not work and could harm the most innocent of consumers. For example, the author uses radiation delivery through brachytherapy as an example of âEURoeexperimentalâEUR surgery that enables surgeons to get more money. But donâEUR(TM)t worry, according to Abelson, there is plenty of blame to go around. The new technology is used at the expense of âEURoethe gold standardâEUR of conventional radiation because reimbursement facilities reward hospitals for using the technology. He points out that conventional radiation has 30 years of use, while brachytherapy, which came out in the mid 1990s, logically does not have such venerable evidence. And while he does explain that brachytherapy enables patients to receive treatment in a much shorter time and recover faster (five days versus six weeks) with fewer complications, he doesnâEUR(TM)t make the logical leap that it ultimately saves hospitals money and is more convenient and represents less risk for patients than traditional radiation. So, according to Abelson, all players involved are to blame. FDA does not properly vet devices put forth by greedy medical device firms, who trick FDA into giving them market approval without having to prove efficacy. Medicare enables this system by rewarding greedy surgeons who embrace the new technologies. WonâEUR(TM)t someone please think of the patient?

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