5 ms·

> They are also (rightly) highly regulated. A next step is trying to figure out how to maintain quality and safety in these kinds of DIY projects. I can see wh

> They are also (rightly) highly regulated. A next step is trying to figure out how to maintain quality and safety in these kinds of DIY projects. I can see why medical devices like pacemakers or implanted replacement joints need more regulation, but I don't understand why a prosthetic needs more regulation than other consumer products like gloves or eyeglasses.

Qantourisc 12y ago
I agree, although they should fall under tools. Like "Should try not to break in a way that could be harmful to the operator of the device."
icegreentea 12y ago
I broad terms I agree that there's probably too much regulation on medical devices in general. There are a variety of areas where there can be considerable stream lining or reduction to the net benefit of all parties involved. That said, the myoelectric device at a minimum falls under some level of regulation since it is a biopotential device. The moment you start measuring potentials on the human body, you add the risk of injecting current across the human body - obviously bad. If you wanted to ensure that the myoelectric device was safe, you would at a minimum ensure that a) sufficient isolation between the sensory and actuator circuits b) a safe sensory circuit. Now, while doing that is probably relatively trivial to actually design, you do need to verify it. So, once again, I agree that there's probably too much regulation piled on, but there is a good reason to regulate/verify in some form or way at least the myoelectric device. More generally, notice that the examples that you and sister component pointed out are relatively simple, especially compared to a prosthetic hand. Complexity in itself can cause the need for regulation. Oh, and on the side, you may find this document with regards to impact resistant and safety glasses (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070579.htm#3 http://www.fda.gov/medicaldevices/deviceregulationandguidanc...) a fun read =P.

Qantourisc 12y ago

I agree, although they should fall under tools. Like "Should try not to break in a way that could be harmful to the operator of the device."

icegreentea 12y ago

I broad terms I agree that there's probably too much regulation on medical devices in general. There are a variety of areas where there can be considerable stream lining or reduction to the net benefit of all parties involved. That said, the myoelectric device at a minimum falls under some level of regulation since it is a biopotential device. The moment you start measuring potentials on the human body, you add the risk of injecting current across the human body - obviously bad. If you wanted to ensure that the myoelectric device was safe, you would at a minimum ensure that a) sufficient isolation between the sensory and actuator circuits b) a safe sensory circuit. Now, while doing that is probably relatively trivial to actually design, you do need to verify it. So, once again, I agree that there's probably too much regulation piled on, but there is a good reason to regulate/verify in some form or way at least the myoelectric device. More generally, notice that the examples that you and sister component pointed out are relatively simple, especially compared to a prosthetic hand. Complexity in itself can cause the need for regulation. Oh, and on the side, you may find this document with regards to impact resistant and safety glasses (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070579.htm#3 http://www.fda.gov/medicaldevices/deviceregulationandguidanc...) a fun read =P.