(no title)
wiskinator | 1 year ago
Also, genuinely I’d be interested in helping this guy hack his exoskeleton to let it work again.
wiskinator | 1 year ago
Also, genuinely I’d be interested in helping this guy hack his exoskeleton to let it work again.
yellers|1 year ago
akira2501|1 year ago
https://www.accessdata.fda.gov/cdrh_docs/reviews/den130034.p...
The problem here, of course, is it's not the device itself, but the simple remote control peripheral that is designed to switch device operating modes.
The FDA should force manufacturers of "two piece" systems like this to have backup controls on the device itself and to exclude these non-medical components designed for control from any regulation covering "intended design life."
It seems like a daffy middle ground that the FDA lets exist and manufacturers take advantage of when they can.
tomrod|1 year ago
anigbrowl|1 year ago
dumbfounder|1 year ago
Also, this line is beyond ridiculous:
"Straight’s path to paralysis started in the 1990s at the Saratoga Race Course".
Ekaros|1 year ago
fargle|1 year ago
why is that ridiculous? seems tragic to me; not to mention the horse broke his neck as well.
kleiba|1 year ago
cptaj|1 year ago
It seems abundantly reasonable that a similar requirement be imposed for prosthesis. And it would also be very reasonable for the required period to be longer than that of cars.
So yeah, not forever, but definitely not a a short period either.
jjk166|1 year ago
In this specific case, the real issue is just the incredibly short service lifetime. While different medical devices are going to have different lifetimes, manufacturers need to continue to provide support for at least 36 months after reporting that they plan to discontinue support, which is 60% of the lifetime of this product. Typically medical devices are supported for much longer.
squarefoot|1 year ago
Yes, and also why products should be open sourced and documented when they're declared obsolete by their manufacturer, or the manufacturer cease operations. Let people be responsible for all repairs they do to their devices; this man would probably not give a damn about regulations if the alternative was essentially to become paralyzed again.
ars|1 year ago
He just needs a part. (They did eventually send it to him.) If they had not, he doesn't need the right to repair it, rather would need someone to manufacture the part.
rkhassen9|1 year ago
the_gorilla|1 year ago
Right to repair, in a broad sense, also covers access to parts. This is definitely an edge case and we might want to just consider that if we're going to do experiments on disabled with the aim of helping them, and they want to continue using the tools, we might have to subsidize access to the parts until they die.