They want a:
> global medical device registry where patient outcomes for all medical devices are openly monitored
A global open database of people’s most sensitive medical information, what could go wrong.
> global medical device registry where patient outcomes for all medical devices are openly monitored
A global open database of people’s most sensitive medical information, what could go wrong.
Money distorts incentives in ways that are not always desired.
First, the product is considered 100% unsafe and criminal to use until going through some defined set of steps.
Then it is considered 100% safe forever, and no further knowledge needs to be collected.
Any sane system based on gathering knowledge and saving lives would be very different.
A risk/benefit profile is what drugs have.
Even there, 100% is an overstatement, there are some minor and slow feedback mechanisms.
By the way, every medical device will have a registry number that you can certainly use to browse for things like recall notices.
Like I understand that metal in plastic has a long history of use and that in practice that means that they likely have lower risk (in the sense that there are probably less unknown unknowns and known unknowns). But it still feels a little weird, since it doesn't automatically reduce the risk of any specific product/implementation.
(For context, compression socks designed to prevent blood pooling in the legs are also Class 2... but all other medical compression socks are Class 1).
I feel like that mechanism makes sense for somethings, but certainly feels kinda sketchy for other things.