58 news organizations are investigating medical devices (Cal

This category is meant for discussion of technical legal issues in workers' compensation. If you are an injured worker, do not ask questions here. Go to the Injured Workers' forum.

Re: 58 news organizations are investigating medical devices (Cal

Postby 4anewusers on Tue Dec 04, 2018 8:29 am

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.
Last edited by 4anewusers on Sat Dec 22, 2018 10:39 am, edited 1 time in total.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
4anewusers
 
Posts: 72
Joined: Sat Mar 15, 2014 1:09 pm

Re: 58 news organizations are investigating medical devices (Cal

Postby LawAdvocate on Tue Dec 04, 2018 9:35 am

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 .
LawAdvocate
 
Posts: 1167
Joined: Wed Jun 11, 2014 10:55 am

Re: 58 news organizations are investigating medical devices (Cal

Postby 4anewusers on Mon Dec 10, 2018 7:02 pm

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.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
4anewusers
 
Posts: 72
Joined: Sat Mar 15, 2014 1:09 pm

Previous

Return to Legal

Who is online

Users browsing this forum: No registered users and 4 guests

cron