Patients shocked, burned by spinal cord stimulators touted to treat pain(apnews.com)
apnews.com
Patients shocked, burned by spinal cord stimulators touted to treat pain
https://apnews.com/86ba45b0a4ad443fad1214622d13e6cb
8 comments
"Unlike drugs, implants don’t need to go through clinical trials in most cases."
The artical says "surgical innovations" which probably means instruments and procedures. Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).
All medical devices of Class 2 and 3 must go through clinical trials to prove safety and efficacy as part of the FDA IDE. Spinal implants would certainly be Class 3.
Edit: clarification
The artical says "surgical innovations" which probably means instruments and procedures. Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).
All medical devices of Class 2 and 3 must go through clinical trials to prove safety and efficacy as part of the FDA IDE. Spinal implants would certainly be Class 3.
Edit: clarification
> Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).
How about if the implant kills the patient?
There was a local story today about a pacemaker where the electrode had failed and he was defibrilated 47 times during 3 hours before the battery ran out.
How about if the implant kills the patient?
There was a local story today about a pacemaker where the electrode had failed and he was defibrilated 47 times during 3 hours before the battery ran out.
It depends if the implant does more good than if it wasn't implanted. All regulated devices require post market monitoring by the company and reporting to the FDA. If the data shows harm is being done to patients the FDA can issue a recall.
That seems like a very slow process. Another story today that implants has caused 83 000 deaths.
I assume/hope they have saved much more lives than that but regardless the types of failures seems to indicate that a lot more could be demanded of these products.
http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-...
I assume/hope they have saved much more lives than that but regardless the types of failures seems to indicate that a lot more could be demanded of these products.
http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-...
Unlike drugs, implants don’t need to go through clinical trials in most cases.
That’s a gross oversimplification. Yes, certain devices don’t need to go through clinical trials since their approval is based on a “predicate device” and only involves minimal changes not expected to greatly change the risk-benefit offered.
If you’re developing a brand new, never seen before device, you will have to conduct clinical trials.
That’s a gross oversimplification. Yes, certain devices don’t need to go through clinical trials since their approval is based on a “predicate device” and only involves minimal changes not expected to greatly change the risk-benefit offered.
If you’re developing a brand new, never seen before device, you will have to conduct clinical trials.
They make a pretty good counter-argument in the article:
> “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.”
The bigger problem seems to be responding quickly (or responding at all) to real life injuries/issues with medical devices than the approval process.
> “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.”
The bigger problem seems to be responding quickly (or responding at all) to real life injuries/issues with medical devices than the approval process.
I observed a total knee replacement surgery where the surgeons were not using their preferred system due to the fact that the patient already had one knee replacement and the doctors felt the same system should be used on both sides. The representative from the implant company was in the OR for a couple of good reasons. The first was that every system uses different jigs and guides to aid in the resection of the bone and placement of the appliance, the representative helped the doctors understand how to use the system. The second reason was that the surgeons needed to have access to a range of component sizes to make sure they could place a correctly sized implant. Using the same system on both knees also helped ensure that the geometry of both knees would be consistent.
At the time I was pretty stunned that the rep was talking the docs through the operation but the procedure was successful and I learned that when new devices are introduced it is very often the company that trains surgeons in its use.
At the time I was pretty stunned that the rep was talking the docs through the operation but the procedure was successful and I learned that when new devices are introduced it is very often the company that trains surgeons in its use.
In my experience of this sort of situation, the reps are there to yell ‘stop’ when the orthopod tries to smack something fragile with a hammer.
Each sub speciality has its traits and orthopaedics is no exception.
> Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.
> Although there are roughly 4,000 types of medical devices in the FDA’s data, just six of them accounted for a quarter of device injury reports since 2008. (Francois Duckett/AP) But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.
This is shocking (pun not intended). I understand the desire and rush to get us off of opioids, but I think this is a horrific reminder that we still need to approach things cautiously and not get swept up in excitement and the promise of a "panacea"
> Although there are roughly 4,000 types of medical devices in the FDA’s data, just six of them accounted for a quarter of device injury reports since 2008. (Francois Duckett/AP) But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.
This is shocking (pun not intended). I understand the desire and rush to get us off of opioids, but I think this is a horrific reminder that we still need to approach things cautiously and not get swept up in excitement and the promise of a "panacea"
the promise of a "panacea"
Especially considering that the “panacea” of OxyContin’s “impossible to abuse” marketing is kinda what got us into this mess in the first place.
Especially considering that the “panacea” of OxyContin’s “impossible to abuse” marketing is kinda what got us into this mess in the first place.
Such a device has been life-changing for my elderly father, who is in constant pain. No malfunctions so far -- don't know the exact product, this is Germany.
From the 1930s to the 1950s, 'fluoroscopes' used strong x-rays to let customers and employees of many shoe stores consider shoe 'fit'. Each second they were turned-on exposed customers -adults and children- to a year's worth of natural exposure. And employees?
New medical technologies should be avoided during the de-bugging stages. Guinea pigs are underpaid.
New medical technologies should be avoided during the de-bugging stages. Guinea pigs are underpaid.
If this device works in a certain percentage of users, what is the problem?
Pain sufferers have further options i.e. opiates
As one who's been in this exact situation it seems very good that there is a partially workable option.
If it causes other issues they can fall back to the other ( opiate ) treatments
Basic ethics? Seriously, think through the implications of allowing companies to sell medical treatment that don't mention the risks.
I would assume that in the US as with the UK with any implanted device/surgery the doctor/surgeon goes through the risks.
I have done this several times in the UK - oh and one of the most serious ones was 1/5000 chance of death :-)
I have done this several times in the UK - oh and one of the most serious ones was 1/5000 chance of death :-)
Unlike drugs, implants don’t need to go through clinical trials in most cases.
Furthermore, there is no central registry for aggregating problems that patients experience with particular devices.
[1] https://www.theguardian.com/society/2018/nov/25/revealed-fau...
Edit: Summarized main problems from The Guardian article.