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They want a: > global medical device registry where patient outcomes for all medical devices are openly monitored A global open database of people’s most sens

They want a: > global medical device registry where patient outcomes for all medical devices are openly monitored A global open database of people’s most sensitive medical information, what could go wrong.

cannonedhamster 7y ago
You can measure outcomes without specifics of who was impacted. The doctor actually as a bulwark in this case and only provides the data specific to the devices as a report. I.e. we performed 175 hip replacement surgeries using x device. During that time there was a median issue rate of x percent. This is within x range of standard. This would have the added benefit of evaluating the medical professionals against similar circumstances especially if you factors in removing outliers that have a higher risk profile.
macspoofing 7y ago
That's a mess. How do you measure patient outcomes of, say, using a radiology software package (which is typically designated a Class 2 Medical Device)? By the way, every medical device will have a registry number that you can certainly use to browse for things like recall notices.
- icegreentea2 7y ago
  I think that gets to the heart of one of the problems in the current system, which is that Class 2 is hilariously broad and the distinction between Class 2 and Class 3 is also little odd... For example, I actually had no idea that metal in plastic hip implants were Class 2. I think the fact that metal in plastic hip implants are Class 2, but metal on metal were shifted to Class 3 points to something being really off in how the system is implemented. Like I understand that metal in plastic has a long history of use and that in practice that means that they likely have lower risk (in the sense that there are probably less unknown unknowns and known unknowns). But it still feels a little weird, since it doesn't automatically reduce the risk of any specific product/implementation. (For context, compression socks designed to prevent blood pooling in the legs are also Class 2... but all other medical compression socks are Class 1).
  - Konnstann 7y ago
    Medical device regulation has a clause where if your product is close enough to a product that is already approved there is a shorter regulatory process, that could apply here. There's a lot of grandfathering of medical devices due to those rules.
    - icegreentea2 7y ago
      Oh yes I know (I work at a company making diagnostic medical devices). I feel like that mechanism makes sense for somethings, but certainly feels kinda sketchy for other things.
refurb 7y ago
Jesus! As someone who works in the Pharma industry that’s dam near impossible. We’d love to get outcomes data for our product post-approval. Getting that data is damn near impossible as physicians have zero incentive to provide it, even when something goes wrong.
- ouid 7y ago
  So provide an incentive. If Pharma has an obligation to gather that data, they can be required to incentivize physicians.
  - marcinzm 7y ago
    Then physicians will send fake data because they can't track many patients but still want money or just don't want to put the effort into tracking. Since they can't send back individual tracking info trying to filter out the false data will be nearly impossible. Money distorts incentives in ways that are not always desired.
- icegreentea2 7y ago
  Oh, nice to see it's not just us. We build diagnostic devices, and getting some performance data (like how frequently our device provides inconclusive readings) out of some hospitals networks is a pain.
- BurningFrog 7y ago
  Yeah, the current binary model of "proven safe" is utterly broken. First, the product is considered 100% unsafe and criminal to use until going through some defined set of steps. Then it is considered 100% safe forever, and no further knowledge needs to be collected. Any sane system based on gathering knowledge and saving lives would be very different.
  - refurb 7y ago
    No one in the industry calls drugs 100% unsafe or 100% safe. That’s why there is a long list of side effects on every drug commercial. A risk/benefit profile is what drugs have.

cannonedhamster 7y ago

You can measure outcomes without specifics of who was impacted. The doctor actually as a bulwark in this case and only provides the data specific to the devices as a report. I.e. we performed 175 hip replacement surgeries using x device. During that time there was a median issue rate of x percent. This is within x range of standard. This would have the added benefit of evaluating the medical professionals against similar circumstances especially if you factors in removing outliers that have a higher risk profile.

macspoofing 7y ago

That's a mess. How do you measure patient outcomes of, say, using a radiology software package (which is typically designated a Class 2 Medical Device)? By the way, every medical device will have a registry number that you can certainly use to browse for things like recall notices.

icegreentea2 7y ago
I think that gets to the heart of one of the problems in the current system, which is that Class 2 is hilariously broad and the distinction between Class 2 and Class 3 is also little odd... For example, I actually had no idea that metal in plastic hip implants were Class 2. I think the fact that metal in plastic hip implants are Class 2, but metal on metal were shifted to Class 3 points to something being really off in how the system is implemented. Like I understand that metal in plastic has a long history of use and that in practice that means that they likely have lower risk (in the sense that there are probably less unknown unknowns and known unknowns). But it still feels a little weird, since it doesn't automatically reduce the risk of any specific product/implementation. (For context, compression socks designed to prevent blood pooling in the legs are also Class 2... but all other medical compression socks are Class 1).
- Konnstann 7y ago
  Medical device regulation has a clause where if your product is close enough to a product that is already approved there is a shorter regulatory process, that could apply here. There's a lot of grandfathering of medical devices due to those rules.
  - icegreentea2 7y ago
    Oh yes I know (I work at a company making diagnostic medical devices). I feel like that mechanism makes sense for somethings, but certainly feels kinda sketchy for other things.

refurb 7y ago

Jesus! As someone who works in the Pharma industry that’s dam near impossible. We’d love to get outcomes data for our product post-approval. Getting that data is damn near impossible as physicians have zero incentive to provide it, even when something goes wrong.

ouid 7y ago
So provide an incentive. If Pharma has an obligation to gather that data, they can be required to incentivize physicians.
- marcinzm 7y ago
  Then physicians will send fake data because they can't track many patients but still want money or just don't want to put the effort into tracking. Since they can't send back individual tracking info trying to filter out the false data will be nearly impossible. Money distorts incentives in ways that are not always desired.
icegreentea2 7y ago
Oh, nice to see it's not just us. We build diagnostic devices, and getting some performance data (like how frequently our device provides inconclusive readings) out of some hospitals networks is a pain.
BurningFrog 7y ago
Yeah, the current binary model of "proven safe" is utterly broken. First, the product is considered 100% unsafe and criminal to use until going through some defined set of steps. Then it is considered 100% safe forever, and no further knowledge needs to be collected. Any sane system based on gathering knowledge and saving lives would be very different.
- refurb 7y ago
  No one in the industry calls drugs 100% unsafe or 100% safe. That’s why there is a long list of side effects on every drug commercial. A risk/benefit profile is what drugs have.