7 ms·

The first open-source ventilator tested on human patients

182 points by baptistejamin 6y ago

meekrohprocess 6y ago
Much respect to these people for continuing the project even after it became clear that ventilators aren't uniquely useful for treating covid. If they can get the relevant certifications and work out how to handle reliable servicing, it could be a significant boon to the medical community, especially in areas where cost is an issue. Better yet, it could show people that it is possible to develop critical medical devices without relying on a heavy veil of secrecy and NDAs, and give a much-needed leg up to projects developing devices like ultrasound imagers or EKGs/EEGs/etc. Here's hoping they can clear the regulatory hurdles without much difficulty and let people buy them without MIT-style license disclaimers, but it looks like those problems will likely fall on local manufacturers. Which raises an interesting question: is it smart to be the first company to start mass-producing an open-source medical device? You would need to foot the heavy certification bill as a large capital investment, while any future competitors wouldn't.
- Dahoon 6y ago
  They should just go for markets that aren't made up of lawyers that want to sue everyone and medical companies that want to rip everyone off. So somewhere outside the US. The EU would likely be a more welcoming market for open source.
  - emteycz 6y ago
    The EU is about as hostile to open source as the US is, and it's also considerably anti-business compared to the US, which manifests e. g. as extremely complicated regulatory requirements, which is not really what open source shines at.
    - capableweb 6y ago
      > it's also considerably anti-business [...] extremely complicated regulatory requirements Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else) I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sign some papers, pay the necessary fees (if even needed, not always a requirement) and make sure the company reports accurate numbers each quarter and you're basically good to go. Is it any easier in the US? Or are you simply echoing other peoples opinions here?
      - inglor_cz 6y ago
        IDK if "cz" means Czechia in the name of OP, but yes, once you employ somebody and are a VAT payer, your paperwork goes way up. You can outsource it to your accountant, though. AFAIK employment is bureaucratically easier in the US and none of the US states even has VAT. But other barriers have fallen recently. If you wanted to start a Ltd company here in Czechia around 2005, all the necessary paperwork took about 100 days to complete. This has been optimized, now it takes just several days and the fees have been cut in half.
        donaltroddyn 6y ago
        Only five US States don't have Sales Tax, and most counties and cities have their own, too.
        Taniwha 6y ago
        I ran a business in California - there sales tax is incredibly more difficult to manage than the VAT (GST) here in New Zealand. Imagine having to charge someone a different sales tax rate depending on which county they live in .....
      - emteycz 6y ago
        I was born in, live, work and do business in the EU. Perhaps you're talking about one of the 'free' sectors? My IT services business is as easy as you say, even being a VAT payer is not that bad to me (but is to others in different sectors). Medical devices, or e. g. people transportation (which I have experience with) are the polar opposite.
- emidln 6y ago
  Would another manufacturer automatically inherit your certifications? I'm ignorant here, but I would be very surprised to learn that merely having the same basic schematics means no certification cost.
  - peterfield 6y ago
    No they won't indeed. And that's a common misunderstanding within the "makers" community that Regulatory bodies approve or authorize a "Design". They approve a design and its supply chain, in the context of a specific market, intended use and indication for use.
- mushufasa 6y ago
  > is it smart to be the first company to start mass-producing an open-source medical device? Certainly none of the existing ventilator companies would have that incentive. The best case would be public funding -- a country with a large enough single-payer system could potentially justify as cost-saving and building supply chain resiliency. A new company, that doesn't have to worry about cannibalizing its existing line of business, may be able to make it work also. Just because a business model is less lucrative than another doesn't mean it's infeasible.
- hutzlibu 6y ago
  "even after it became clear that ventilators aren't uniquely useful for treating covid." Is that established knowledge now? I remember the discussions about it here on HN quite early, but for example here in germany, I believe lung ventilators are still the tool of choice for serious cases. At least, I never found information, that they changed policy towards it.
  - Herodotus38 6y ago
    Ventilators are useful, but now that we have more experience, we've learned that you don't need to intubate as early as originally thought, so the original concern that we will run out of ventilators is much less. In my experience, the biggest bottleneck for care has been nursing staff, especially critical care trained nurses.
  - deleted 6y ago
    [deleted]
  - athriren 6y ago
    ventilation is the standard course of care for ARDS and most covid crisis cases present as ARDS. it’s great. don’t look it up. in the first few months, ventilation was used extensively as both a last line of defense and a preventative (maybe we can keep your spo2 above 60% and you will therefore have a better chance to survive). covid presents very strangely for a respiratory infection, especially in regards to spo2 measurement where patients have greatly diminished capacity to carry oxygen but otherwise seem fine—having conscious conversation, walking. there were a couple of months of basically expert trial and error—take what we know of best practices and apply it in a real world setting with no ability to test effectivity other than whether or not your patient lives or dies. this has been awful for hc worker morale, stacked on top of all the other things (bad ppe availability, long hours for months with no end in sight, hospital administration getting paid while they fire hc workers due to lack of elective surgery, etc). we are intervening earlier in more proven ways now (such as proning the patient with supplemental o2 rather than immediately ventilating). we know what we are doing better than we did in march (when we knew almost nothing). but it is still extremely difficult to intervene once a patient declines past a certain threshhold. ventilation is still being used as the “keep this patient alive and hope for the best”, but something like 50% of patients with ARDS die within 3 years anyway so you really don’t want to need to be vented. everyone stay safe. i’m getting the war stories from my sister, who is an ER nurse at Vanderbilt—whose narrative has informed this post since i know fuck all about the application of medicine.
ThinkBeat 6y ago
I do not have the backgrond to know much about this design. I do know that creating them is difficult and even small error can be fatal. I would not want to be a beta tester here if I could avoid it. There will be a long certification process and probably repeated in several different areas of the world. The Norwegian prime minister Erna Solberg decided during the 1st wave of the pandemic in Norway to make "her own" ventilators in Norway and in a hurry. There were many irregularities in the bidding process or rather lack there of and there were irregutlatires in how the -"winning". design was chosen" Once they were made, doctors and nurses refused to ever use it on a patient. Norway then tried to sell then to other countries (at a steep discount) and had no takers. Norway then tried donating them and again no takers. Now they are sitting in one or more warehouses somewhere in Norway. As 2nd wave is making its rounds in Norway, if it should get as chaotic as last time maybe someone will try them. https://www.ffi.no/en/news/emergency-ventilator-in-record-time https://www.ffi.no/en/news/emergency-ventilator-in-record-ti... https://kommunikasjon.ntb.no/pressemelding/norsk-nodrespirator-er-klar?publisherId=17846797&releaseId=17886381 https://kommunikasjon.ntb.no/pressemelding/norsk-nodrespirat... https://www.ffi.no/aktuelt/nyheter/ffi-svarer-pa-kritikken-mot-nodrespiratoren https://www.ffi.no/aktuelt/nyheter/ffi-svarer-pa-kritikken-m... https://www.dagensmedisin.no/artikler/2020/04/01/anestesi-miljoet-hardt-ut-mot-nye-respiratorer/ https://www.dagensmedisin.no/artikler/2020/04/01/anestesi-mi...
- baptistejamin 6y ago
  Hello. I am one of the members of this project. Your comment is totally accurate and a bad ventilator design or manufacturing can be fatal. The Norwegian ventilator design was a dead end since the beginning. Many different makers teams tried to create ventilators around the world by doing mechanization of "Ambubags" (https://en.wikipedia.org/wiki/Bag_valve_mask https://en.wikipedia.org/wiki/Bag_valve_mask). Those makers chose this solution because it was the easiest way to do a ventilator if a few weeks. This idea is bad because it creates many different problems: - After 30 minutes, patients will start having high C02 levels - It spreads the virus in the hospital room - It can clog At the beginning of the pandemic, we choose a completely different design and started something from scratch. Our goal was to make a very safe ventilator, so we could be confident our ourselves, our parents, our family would have to use it. We asked doctors, specialists, we quickly figured out that the best design was using a turbine design as most emergency ventilators come with turbines. The big challenge was to finely the pressure very accurately: so we needed valves to manage the airflow. All the Airflow systems needed to be biocompatible and no pressure valves existed on the market for that purpose. We tried many ways doing that and engineers in the team found that the best way to make those valves was doing a "Pinch Valve" The idea is you have a medical-grade flexible pipe, which is pinched using an excentric valve. This way you can finely tune the pressure. Researchers and doctors tested early prototypes and they found the design was smart and very promising. It was tested on very complicated lung simulators, and then two pigs. Following those studies, french authorities started to look at our project and gave us funding (around 500k euros). Allowing us to have access to 2 ASL 5000, the rolls of lung simulators to try our prototypes. Many different local companies (engineering, manufacturing) help us as well. A complete team (5 people) made internally all the paperwork for French Health Authorities so they can approve clinical trials. After a few months, the Makair was approved for Clinical trials and 2 hospitals started to try it on patients. Meanwhile, we are working on CE marking and production lines. Multiple countries are interested. If we had to start again, we would choose the same design.
Erlich_Bachman 6y ago
Would it be possible to have a design that could be largely 3D-printed?
- baptistejamin 6y ago
  Our initial design was mostly based on 3D printed SLS bio-compatible parts. The current design is still 3D-printable, but we had to go with metal valves for instance for long term usage, and mass-proction. 3D printed parts just don't scale. When possible, we replaced some 3D parts with on-the-shelf parts, for instance for the medical 22mm tubing connectors.
- redis_mlc 6y ago
  > 3D-printed? With typical consumer-grade machines that produce garbage bathtub-toys, no. But there's high-end commercial machines that are more capable.
zabhi 6y ago
And it uses Rust!
tahirkhan17 6y ago
A bit disappointing that your title suggests it's recent news when no work has been done on that repo apart from Readme updates since April. A couple of open-source ventilators have been tested on human patients in France (where this project originates from), all during the same very short period, but none were approved by the health authorities. I would have appreciated at the very least a description of the project and how it's different from other open-source ventilator projects that can be found on GitHub. Maybe that's included in the link you shared in the comments, but reddit's not pinterest, personally posts that are basically a baitclick title and a link to "more on this on my website" annoy me because I feel they don't enable discussion, they are empty self-promotion. For those who would like to know more on the rush to develop open-source ventilators due to the current pandemic, this research paper could be a good starting point: https://f1000research.com/articles/9-218 https://f1000research.com/articles/9-218 I'm afraid I don't have anything more recent because I've stopped doing a serious watch after May. I have no doubt some of the projects are still moving forward but they have been far less mediatised recently.

182 points by baptistejamin 6y ago

Much respect to these people for continuing the project even after it became clear that ventilators aren't uniquely useful for treating covid. If they can get the relevant certifications and work out how to handle reliable servicing, it could be a significant boon to the medical community, especially in areas where cost is an issue. Better yet, it could show people that it is possible to develop critical medical devices without relying on a heavy veil of secrecy and NDAs, and give a much-needed leg up to projects developing devices like ultrasound imagers or EKGs/EEGs/etc. Here's hoping they can clear the regulatory hurdles without much difficulty and let people buy them without MIT-style license disclaimers, but it looks like those problems will likely fall on local manufacturers. Which raises an interesting question: is it smart to be the first company to start mass-producing an open-source medical device? You would need to foot the heavy certification bill as a large capital investment, while any future competitors wouldn't.

Dahoon 6y ago
They should just go for markets that aren't made up of lawyers that want to sue everyone and medical companies that want to rip everyone off. So somewhere outside the US. The EU would likely be a more welcoming market for open source.
- emteycz 6y ago
  The EU is about as hostile to open source as the US is, and it's also considerably anti-business compared to the US, which manifests e. g. as extremely complicated regulatory requirements, which is not really what open source shines at.
  - capableweb 6y ago
    > it's also considerably anti-business [...] extremely complicated regulatory requirements Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else) I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sign some papers, pay the necessary fees (if even needed, not always a requirement) and make sure the company reports accurate numbers each quarter and you're basically good to go. Is it any easier in the US? Or are you simply echoing other peoples opinions here?
    - inglor_cz 6y ago
      IDK if "cz" means Czechia in the name of OP, but yes, once you employ somebody and are a VAT payer, your paperwork goes way up. You can outsource it to your accountant, though. AFAIK employment is bureaucratically easier in the US and none of the US states even has VAT. But other barriers have fallen recently. If you wanted to start a Ltd company here in Czechia around 2005, all the necessary paperwork took about 100 days to complete. This has been optimized, now it takes just several days and the fees have been cut in half.
      - donaltroddyn 6y ago
        Only five US States don't have Sales Tax, and most counties and cities have their own, too.
      - Taniwha 6y ago
        I ran a business in California - there sales tax is incredibly more difficult to manage than the VAT (GST) here in New Zealand. Imagine having to charge someone a different sales tax rate depending on which county they live in .....
    - emteycz 6y ago
      I was born in, live, work and do business in the EU. Perhaps you're talking about one of the 'free' sectors? My IT services business is as easy as you say, even being a VAT payer is not that bad to me (but is to others in different sectors). Medical devices, or e. g. people transportation (which I have experience with) are the polar opposite.
emidln 6y ago
Would another manufacturer automatically inherit your certifications? I'm ignorant here, but I would be very surprised to learn that merely having the same basic schematics means no certification cost.
- peterfield 6y ago
  No they won't indeed. And that's a common misunderstanding within the "makers" community that Regulatory bodies approve or authorize a "Design". They approve a design and its supply chain, in the context of a specific market, intended use and indication for use.
mushufasa 6y ago
> is it smart to be the first company to start mass-producing an open-source medical device? Certainly none of the existing ventilator companies would have that incentive. The best case would be public funding -- a country with a large enough single-payer system could potentially justify as cost-saving and building supply chain resiliency. A new company, that doesn't have to worry about cannibalizing its existing line of business, may be able to make it work also. Just because a business model is less lucrative than another doesn't mean it's infeasible.
hutzlibu 6y ago
"even after it became clear that ventilators aren't uniquely useful for treating covid." Is that established knowledge now? I remember the discussions about it here on HN quite early, but for example here in germany, I believe lung ventilators are still the tool of choice for serious cases. At least, I never found information, that they changed policy towards it.
- Herodotus38 6y ago
  Ventilators are useful, but now that we have more experience, we've learned that you don't need to intubate as early as originally thought, so the original concern that we will run out of ventilators is much less. In my experience, the biggest bottleneck for care has been nursing staff, especially critical care trained nurses.
- deleted 6y ago
  [deleted]
- athriren 6y ago
  ventilation is the standard course of care for ARDS and most covid crisis cases present as ARDS. it’s great. don’t look it up. in the first few months, ventilation was used extensively as both a last line of defense and a preventative (maybe we can keep your spo2 above 60% and you will therefore have a better chance to survive). covid presents very strangely for a respiratory infection, especially in regards to spo2 measurement where patients have greatly diminished capacity to carry oxygen but otherwise seem fine—having conscious conversation, walking. there were a couple of months of basically expert trial and error—take what we know of best practices and apply it in a real world setting with no ability to test effectivity other than whether or not your patient lives or dies. this has been awful for hc worker morale, stacked on top of all the other things (bad ppe availability, long hours for months with no end in sight, hospital administration getting paid while they fire hc workers due to lack of elective surgery, etc). we are intervening earlier in more proven ways now (such as proning the patient with supplemental o2 rather than immediately ventilating). we know what we are doing better than we did in march (when we knew almost nothing). but it is still extremely difficult to intervene once a patient declines past a certain threshhold. ventilation is still being used as the “keep this patient alive and hope for the best”, but something like 50% of patients with ARDS die within 3 years anyway so you really don’t want to need to be vented. everyone stay safe. i’m getting the war stories from my sister, who is an ER nurse at Vanderbilt—whose narrative has informed this post since i know fuck all about the application of medicine.

ThinkBeat 6y ago

I do not have the backgrond to know much about this design. I do know that creating them is difficult and even small error can be fatal. I would not want to be a beta tester here if I could avoid it. There will be a long certification process and probably repeated in several different areas of the world. The Norwegian prime minister Erna Solberg decided during the 1st wave of the pandemic in Norway to make "her own" ventilators in Norway and in a hurry. There were many irregularities in the bidding process or rather lack there of and there were irregutlatires in how the -"winning". design was chosen" Once they were made, doctors and nurses refused to ever use it on a patient. Norway then tried to sell then to other countries (at a steep discount) and had no takers. Norway then tried donating them and again no takers. Now they are sitting in one or more warehouses somewhere in Norway. As 2nd wave is making its rounds in Norway, if it should get as chaotic as last time maybe someone will try them. https://www.ffi.no/en/news/emergency-ventilator-in-record-time https://www.ffi.no/en/news/emergency-ventilator-in-record-ti... https://kommunikasjon.ntb.no/pressemelding/norsk-nodrespirator-er-klar?publisherId=17846797&releaseId=17886381 https://kommunikasjon.ntb.no/pressemelding/norsk-nodrespirat... https://www.ffi.no/aktuelt/nyheter/ffi-svarer-pa-kritikken-mot-nodrespiratoren https://www.ffi.no/aktuelt/nyheter/ffi-svarer-pa-kritikken-m... https://www.dagensmedisin.no/artikler/2020/04/01/anestesi-miljoet-hardt-ut-mot-nye-respiratorer/ https://www.dagensmedisin.no/artikler/2020/04/01/anestesi-mi...

baptistejamin 6y ago
Hello. I am one of the members of this project. Your comment is totally accurate and a bad ventilator design or manufacturing can be fatal. The Norwegian ventilator design was a dead end since the beginning. Many different makers teams tried to create ventilators around the world by doing mechanization of "Ambubags" (https://en.wikipedia.org/wiki/Bag_valve_mask https://en.wikipedia.org/wiki/Bag_valve_mask). Those makers chose this solution because it was the easiest way to do a ventilator if a few weeks. This idea is bad because it creates many different problems: - After 30 minutes, patients will start having high C02 levels - It spreads the virus in the hospital room - It can clog At the beginning of the pandemic, we choose a completely different design and started something from scratch. Our goal was to make a very safe ventilator, so we could be confident our ourselves, our parents, our family would have to use it. We asked doctors, specialists, we quickly figured out that the best design was using a turbine design as most emergency ventilators come with turbines. The big challenge was to finely the pressure very accurately: so we needed valves to manage the airflow. All the Airflow systems needed to be biocompatible and no pressure valves existed on the market for that purpose. We tried many ways doing that and engineers in the team found that the best way to make those valves was doing a "Pinch Valve" The idea is you have a medical-grade flexible pipe, which is pinched using an excentric valve. This way you can finely tune the pressure. Researchers and doctors tested early prototypes and they found the design was smart and very promising. It was tested on very complicated lung simulators, and then two pigs. Following those studies, french authorities started to look at our project and gave us funding (around 500k euros). Allowing us to have access to 2 ASL 5000, the rolls of lung simulators to try our prototypes. Many different local companies (engineering, manufacturing) help us as well. A complete team (5 people) made internally all the paperwork for French Health Authorities so they can approve clinical trials. After a few months, the Makair was approved for Clinical trials and 2 hospitals started to try it on patients. Meanwhile, we are working on CE marking and production lines. Multiple countries are interested. If we had to start again, we would choose the same design.

Erlich_Bachman 6y ago

Would it be possible to have a design that could be largely 3D-printed?

baptistejamin 6y ago
Our initial design was mostly based on 3D printed SLS bio-compatible parts. The current design is still 3D-printable, but we had to go with metal valves for instance for long term usage, and mass-proction. 3D printed parts just don't scale. When possible, we replaced some 3D parts with on-the-shelf parts, for instance for the medical 22mm tubing connectors.
redis_mlc 6y ago
> 3D-printed? With typical consumer-grade machines that produce garbage bathtub-toys, no. But there's high-end commercial machines that are more capable.

zabhi 6y ago

And it uses Rust!

tahirkhan17 6y ago

A bit disappointing that your title suggests it's recent news when no work has been done on that repo apart from Readme updates since April. A couple of open-source ventilators have been tested on human patients in France (where this project originates from), all during the same very short period, but none were approved by the health authorities. I would have appreciated at the very least a description of the project and how it's different from other open-source ventilator projects that can be found on GitHub. Maybe that's included in the link you shared in the comments, but reddit's not pinterest, personally posts that are basically a baitclick title and a link to "more on this on my website" annoy me because I feel they don't enable discussion, they are empty self-promotion. For those who would like to know more on the rush to develop open-source ventilators due to the current pandemic, this research paper could be a good starting point: https://f1000research.com/articles/9-218 https://f1000research.com/articles/9-218 I'm afraid I don't have anything more recent because I've stopped doing a serious watch after May. I have no doubt some of the projects are still moving forward but they have been far less mediatised recently.