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Re: 58 news organizations are investigating medical devices (Cal

PostPosted: Tue Dec 04, 2018 8:29 am
by 4anewusers
You do not know what devices are implanted into your injured workers until you receive the operative report after they have their surgery? THAT is insane. It should be listed in the request for authorization for surgery.

Re: 58 news organizations are investigating medical devices (Cal

PostPosted: Tue Dec 04, 2018 9:35 am
by LawAdvocate
Insane or not that is the way it works. There is no way for anyone in our industry to keep track of implantable devices. That simple. You don't seem to understand the dynamics of how the medical world works with insurance companies.

Most devices are not FDA approved, they don't know how to do so. SO you again are touting a pipe dream for which there is no infrastructure to rely on .

Re: 58 news organizations are investigating medical devices (Cal

PostPosted: Mon Dec 10, 2018 7:02 pm
by 4anewusers
FDA "approved" devices that have a PMA or HDE application.Most medical devices in the US are cleared by the 510(k) process which is a premarket notification process.It must be submitted to FDA to review and provide clearance. I am very aware of the processes medical devices are either being cleared or approved. Unfortunately the 510k process allows untested, unproven medical devices to be sold.

I was not aware of the inner workings of how a work comp carrier approves medical devices to be placed into a patient, and why I asked the question. I appreciate the responses.


My hope for now is that patients will see some of these investigative reports and documentaries like "The Bleeding Edge" on Netflix and research the medical device or product their doctor wants to implant before they have surgery.