Printing Prosthetic Hands for Children

[techhelpbb]

Originally Posted by Cynette

e-NABLE has each printing organization send in a test hand to do a pre-qualification. The hands are printed to their specifications. The printed hands go to e-NABLE for final assembly and distribution. What liability issues do you see arising?

I used to make modifications to everything from cars to equipment for the handicapped. The insurance involved can be significant. The sorts of things that may happen can be unusual.

I hate to bring this up but what if some child with the prosthetic has it fail while holding something sharp or possibly holding a hand rail? What protections do the people printing this stuff have in writing?

[Cynette]

Originally Posted by techhelpbb

I used to make modifications to everything from cars to equipment for the handicapped. The insurance involved can be significant. The sorts of things that may happen can be unusual.

I hate to bring this up but what if some child with the prosthetic has it fail while holding something sharp or possibly holding a hand rail? What protections do the people printing this stuff have in writing?

How about this? - from their website:

ACCEPTANCE

By accepting any design, plan, component or assembly related to the so called “e-NABLE Hand” , I understand and agree that any such information or material furnished by any individual associated with the design team is furnished as is without representation or warranties of any kind, express or implied, and is intended to be a gift for the sole purpose of evaluating various design iterations, ideas and modifications. I understand that such improvements are intended to benefit individuals having specific disabilities and are not intended, and shall not be used, for commercial use. I further understand and agree that any individual associated with e-NABLE organization shall not be liable for any injuries or damages resulting from the use of any of the materials related to the e-NABLE hand.

[techhelpbb]

Originally Posted by Cynette

How about this? - from their website:

Who agrees to that? The prosthetic user, their guardian or the people doing the printing? How do the people doing the printing request a copy of the signed agreement for their records?

[jee7s]

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:

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.

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.

[Cynette]

Ok. Thanks for all of that detail. We might have done all of that when we were vetted as a printing location, and I'm just not the person in the know!

[Thayer McCollum]

E-nable protects you as a manufacturer. The safety guidelines regarding the hands state that "The person signing below (“You”) is either the individual recipient of the Design or Component if the individual recipient is an adult under the laws of the relevant jurisdiction or the parent or legal guardian of the child if the individual recipient is a child under the laws of the relevant jurisdiction.

Furthermore, You (either for yourself or your child) release and forever discharge the Foundation and its officers, employees, contractors, subcontractors, volunteers and agents (“Releasees”) from any and all liability for acts or omissions— including negligent acts or omissions—causing damage, loss, injury, or death to the individual recipient from the use of the Design or the Component. You agree to defend, indemnify and hold the Releasees harmless from any and all liability or loss— including liability for negligence—arising in conjunction with or resulting from the individual recipient’s use of a Design or Component (including all attorney’s fees and expenses incurred by the Releasees).

You further understand and agree that the Foundation and any individual associated with the Foundation shall not be liable for any injuries or damages, including any consequential, incidental, indirect, punitive or special damages, resulting from or arising out of the use of the Design or Component provided by the Foundation or any individual associated with the Foundation."

Anyone accepting a hand (for themselves or their children) must sign a legal agreement saying anyone involved in the process that brought the hand to them is in no way responsible for anything that happens to them regarding the hand in any way.

So you don't have to worry at all about legal problems. Print away!

[GabrielaH]

This sounds like a wonderful idea and I was hoping to work on this in college. Now I can work on it with my team- this could also be a good pre-season project for new students who want to learn with a hands-on project of which they can take ownership and see results. Can't want to share this with my team!