Dramatic story of how even the simplest medical devices require government approval

Someone please explain to me why it was necessary to get government approval for a simple tube that allowed this baby to breathe.  Fortunately, it was possible to clear this quickly, but why did they have to go through this process at all?  From Fox News:
. . . In the case of Kaiba Gionfriddo, doctors didn't have a moment to spare. Because of a birth defect, the little Ohio boy's airway kept collapsing, causing his breathing to stop and often his heart, too. Doctors in Michigan had been researching artificial airway splints but had not implanted one in a patient yet.In a single day, they "printed out" 100 tiny tubes, using computer-guided lasers to stack and fuse thin layers of plastic instead of paper and ink to form various shapes and sizes. 
The next day, with special permission from the Food and Drug Administration, they implanted one of these tubes in Kaiba, the first time this has been done. . . .



Blogger MaverickNH said...

There's some history there, with a company headed by a surgeon changing a cardiovascular device willy-nilly, and patients living and dying. As usual, someone without morals or ethics induced lawmakers to give government power to regulate and control something, and it turned into a mess. Today, FDA regulators fight over turf and funding, with science/medical eschelons just trying to make it to full-pension retirement and upper levels playing politics.

Sometimes it works, often it doesn't. The rich leave the US for the latest/best care, the well-to-do come to the US for good medical cre and the poor just die.

5/23/2013 7:33 PM  

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