[Boston-Sean]

Very interesting documentary called The Bleeding Edge showing on Netflix about how medical devices are tested and approved. Or rather how they are not tested and still approved.

Specifically, anyone with a device with Cobalt in it should definitely watch this.

[Northwoods]

Originally Posted by Boston-Sean

Very interesting documentary called The Bleeding Edge showing on Netflix about how medical devices are tested and approved. Or rather how they are not tested and still approved.

Specifically, anyone with a device with Cobalt in it should definitely watch this.

Can you be more specific about medical devices? Imaging devices like MR, CT, etc. need to be FDA cleared to be sold in the US. It's a long, expensive process. Yes... many physicians prescribe things "off label," but that isn't on a whim. I'm curious what medical devices you are referring to.

[Boston-Sean]

Originally Posted by Northwoods

Can you be more specific about medical devices? Imaging devices like MR, CT, etc. need to be FDA cleared to be sold in the US. It's a long, expensive process. Yes... many physicians prescribe things "off label," but that isn't on a whim. I'm curious what medical devices you are referring to.

Sure, by medical device I mean things inserted in humans. Not equipment like MRI machines.

Joint implants, stents, etc.

I think the stat for how devices are approved was 97% are being approved based only on the testing of some other "similar" device. A chain of devices can get approved that way. And even if the source device is pulled off the market that does not affect the daisy chain of approvals based on that faulty device.

It's a screwed up system and an eye opening documentary.