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Unread 25-04-2016, 12:12
jee7s jee7s is offline
Texan FIRSTer, ex-frc2789, ex-frc41
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Re: Printing Prosthetic Hands for Children

To echo techhelpbb, using the word "Prosthetic" attaches a connotation of a medical device to their product. Their own website mentions doing the work in consult with a physician:

Quote:
Please do not use these devices without consulting a physician prior to use and consult with them as to the best fit and use for you or the person you have created it for.
Quote:
Please make sure you communicate with a licensed medical professional before you begin and consult with them as you begin to use the device.
So, don't just print them and hand them out. Make sure you are working with someone who is licenced to practice in the field, as the website suggests.

Also while their website has a rather thorough Waiver of Liability with Hold Harmless clause (http://enablingthefuture.org/safety-guidelines/), that may not hold up if certain three letter agencies decide this is a medical device. In foreign countries, that might be an even more onerous governmental organization.

Don't get me wrong, though, this sounds like an awesome idea to help people who can really benefit from techonology. I would just be worried that the byzantine nature of regulation that surrounds anything approaching "medical" might rear its ugly head.

I think the thing that's really missing is an explicit agreement with the printer. The folks at e-NABLE need something in an agreement that says as a volunteer who prints and delivers the devices that you, the printer, will be held harmless and e-NABLE will indemnify you. Indemnify is the key word, as that means that e-NABLE essentially pays your bills if someone tries to take action against you as the manufacturer.
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Last edited by jee7s : 25-04-2016 at 12:19.
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