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There’s a broader story about poor regulation in the medical implant industry as a whole. [1] Unlike drugs, implants don’t need to go through clinical trials i

by scribu 8y ago

There’s a broader story about poor regulation in the medical implant industry as a whole. [1] 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-faulty-medical-implants-harm-patients-around-world https://www.theguardian.com/society/2018/nov/25/revealed-fau... Edit: Summarized main problems from The Guardian article.

flarets 8y ago
"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
- tjoff 8y ago
  > 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.
  - flarets 8y ago
    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.
    - tjoff 8y ago
      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-medical-devices-in-10-years--.SkeMIhDd0Q.html http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-...
dmix 8y ago
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.
refurb 8y ago
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.

by scribu 8y ago

flarets 8y ago

"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

tjoff 8y ago
> 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.
- flarets 8y ago
  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.
  - tjoff 8y ago
    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-medical-devices-in-10-years--.SkeMIhDd0Q.html http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-...

dmix 8y ago

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.

refurb 8y ago

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.