Dying Baby Saved By 3-D Printer

[roo_ster]

http://www.outsidethebeltway.com/dying-baby-saved-by-3-d-printer/

What followed in Kaiba’s case was a painstaking process of creating the splint on the printer in layers. Information about each layer is transmitted from the computer to a laser beam, which melts the PCL into a 3-D structure.

“We can put together a complete copy of a body part on the 3-D printer within a day,” Green said. “So we can make something very specific for a patient very quickly.”

Green then took the splint, measuring just a few centimeters long and 8 millimeters wide, and surgically attached it to Kaiba’s collapsed bronchus. It was only moments before he saw the results.

“When the stitches were put in, we started seeing the lung inflate and deflate,” Green said. “It was so fabulous. There were people in the operating room cheering.”

Obviously, we need to regulate the crap out of this and, since the result is a medical device itself, it needs months years long  independent clinical trials before it is installed in the child and, of course, the Obamacare tax must be applied to it.

[AZRedhawk44]

Beautiful story!

Long live freedom of information in all manifestations.

[Gewehr98]

Obviously, we need to regulate the crap out of this and, since the result is a medical device itself, it needs months years long  independent clinical trials before it is installed in the child and, of course, the Obamacare tax must be applied to it.

As somebody who works in the medical device industry, and works my little regulatory tail off to make sure everything's perfect for 510(k) submission, I question the above statement.  Two words strike terror in the medical device world: "Adverse Event".

[roo_ster]

As somebody who works in the medical device industry, and works my little regulatory tail off to make sure everything's perfect for 510(k) submission, I question the above statement.  Two words strike terror in the medical device world: "Adverse Event".

I made one assumption: The regulatory burden imposed would be predicated on what gave the most power to the regulators, not what was best for the patient or reasonable for manufacturer compliance.

[Sawdust]

Well, good thing that docs may use devices off-label based soley on their own judgement (and sometimes need permission from hospital review boards, depending on their contractual agreements).

At least, that's the way it is (and has been for decades) now...

Sawdust

[Gewehr98]

Yup.  Off-label is at the discretion of the doctor.  Were this to be marketed for that indication, then all the normal rules apply.

[Hawkmoon]

WWHD *



















* What Would House Do?

[zahc]

Yup.  Off-label is at the discretion of the doctor. 

Too bad it's only at the discretion of doctors, and not anyone.

[Gewehr98]

Too bad it's only at the discretion of doctors, and not anyone.

 

You mean, like Cliffy down at the Cheers bar?

[zahc]

It was pointed out there is a loophole whereby the State will allow use of "medical devices" without FDA approval. I was pointing out that said loophole is only available to approved physicians. It's nice to be a doctor; the  you can take advantage of all kinds of modern lifesaving technology. But I'm not sure I should celebrate that.