The usual comment we hear on usage of this is that OSH equipment like a simple hammer would have to present a disclaimer such as "Can be fatal if used wrongly -

The usual comment we hear on usage of this is that OSH equipment like a simple hammer would have to present a disclaimer such as "Can be fatal if used wrongly -- bashing one's head with this device may prove dangerous" - but doesn't bring a lot to the debate. That being said, open source medical hardware is quite a new field, and lot of aspects need to be matured.