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Yes, it is. Medical devices have to be FDA approved (or the equivalent in other countries) and that costs LOTS of money. On top of that, you have to account fo

Yes, it is. Medical devices have to be FDA approved (or the equivalent in other countries) and that costs LOTS of money. On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.

AnthonyMouse 7y ago
> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies. Where does this meme that companies get sued for parts made by completely independent third parties come from? The most obvious reason that wouldn't be true is that without a patent on the part or similar, companies generally have no right to prevent third parties from making replacement parts for their equipment. It would be pretty silly to impose liability for something they have no control over.
- Turing_Machine 7y ago
  > Where does this meme that companies get sued for parts made by completely independent third parties come from? "Meme"? Where does your your that malpractice lawsuits are just "memes" come from? Because I can assure you that they exist in the real world. As do massive fines for using equipment that hasn't been FDA approved.
enriquto 7y ago
> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies. In that case, the alternative was a few people over there going to die by slow asphyxiation, so the 3D-printed knockoffs were a really good thing, even if some of them failed.
- UnpossibleJim 7y ago
  Except, that the 3D printer plastic might not hold up to the medical grade plastic and might cause system wide infections that hadn't been accounted for culminating in a brain or spinal infection that leaves a person in a coma for the rest of their painful life while the family watches. The family then Sue's malpractice, doctor's lose their medical license and hospitals lose millions which could go to treat patients. Hypotheticals can go both ways.
  - unionpivo 7y ago
    Thats why they printed so many, that they can change them for each patient.
  - enriquto 7y ago
    Yes, this is a difficult decision. If you were a doctor what would you do? Let the patient die today, or try the newly 3D printed valve that looks and feels like the real one but may have unintended side effects?
nexuist 7y ago
As opposed to not having a valve at all? The hospital wouldn't need knockoff valves if they had the real thing. In such dire circumstances I don't think any judge would fault you for going the unconventional route to deliver results. It's similar to how captains on boats and airplanes are allowed to break almost any regulation in the book to ensure the safety of their passengers.
- sokoloff 7y ago
  This. I have set this policy as the first rule of our SRE response teams to make it clear the broad extent of their power. Because it’s our written policy, it’s incorporated into our PCI and SOX compliance programs as well. The auditors don’t always love it, but we’ve always gotten them to understand. The aviation law: https://www.law.cornell.edu/cfr/text/14/91.3 https://www.law.cornell.edu/cfr/text/14/91.3

AnthonyMouse 7y ago

> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies. Where does this meme that companies get sued for parts made by completely independent third parties come from? The most obvious reason that wouldn't be true is that without a patent on the part or similar, companies generally have no right to prevent third parties from making replacement parts for their equipment. It would be pretty silly to impose liability for something they have no control over.

Turing_Machine 7y ago
> Where does this meme that companies get sued for parts made by completely independent third parties come from? "Meme"? Where does your your that malpractice lawsuits are just "memes" come from? Because I can assure you that they exist in the real world. As do massive fines for using equipment that hasn't been FDA approved.

enriquto 7y ago

> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies. In that case, the alternative was a few people over there going to die by slow asphyxiation, so the 3D-printed knockoffs were a really good thing, even if some of them failed.

UnpossibleJim 7y ago
Except, that the 3D printer plastic might not hold up to the medical grade plastic and might cause system wide infections that hadn't been accounted for culminating in a brain or spinal infection that leaves a person in a coma for the rest of their painful life while the family watches. The family then Sue's malpractice, doctor's lose their medical license and hospitals lose millions which could go to treat patients. Hypotheticals can go both ways.
- unionpivo 7y ago
  Thats why they printed so many, that they can change them for each patient.
- enriquto 7y ago
  Yes, this is a difficult decision. If you were a doctor what would you do? Let the patient die today, or try the newly 3D printed valve that looks and feels like the real one but may have unintended side effects?

nexuist 7y ago

As opposed to not having a valve at all? The hospital wouldn't need knockoff valves if they had the real thing. In such dire circumstances I don't think any judge would fault you for going the unconventional route to deliver results. It's similar to how captains on boats and airplanes are allowed to break almost any regulation in the book to ensure the safety of their passengers.

sokoloff 7y ago
This. I have set this policy as the first rule of our SRE response teams to make it clear the broad extent of their power. Because it’s our written policy, it’s incorporated into our PCI and SOX compliance programs as well. The auditors don’t always love it, but we’ve always gotten them to understand. The aviation law: https://www.law.cornell.edu/cfr/text/14/91.3 https://www.law.cornell.edu/cfr/text/14/91.3