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The first open-source ventilator tested on human patients

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Re: The first open-source ventilator tested on human patients

#21

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 devi…

"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.

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.

Re: The first open-source ventilator tested on human patients

#23
post #14

Earlier quoted context omitted.

thanks for sharing so many details about the process. 1. quality controls for medical devices are necessary since they can be fatal as you said. that said, are there ways of accelerating the certification/control process without sacrificing quality? 2. it sounds like you had access to great local talent. how could we improve the collaboration process so other people could contribute to the design process? 3. if you w…

1. What we did is we worked on certification and on the eneenering at the same time. We figured out that it was easier to certify an hospital ventilator rather than an emegerncy transport ventilator. An emergency ventilator needs to support 15G (so around 330KG in our case) accelerations. Quite a lot :) So, we choose to the "hospital ventilator" regulations then. We unit tested everything using a lung simulator (ASL…

> [Software certification] is something that needs to change, because in the future, we will have more and more sotware in medical devices.

I think this is wrong thinking. Software which drives safety critical systems needs to be perfect, and that is an impossible bar. Whether or not such a target is achievable, it is much MUCH harder if the software is under continuous development. It needs to take enough time to do it properly, and therefore software for critical systems ends up basically being your MVP. It does only what it must, but it does it right. You really don't get a second chance on safety critical systems.

Re: The first open-source ventilator tested on human patients

#24
post #4

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 devi…

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.

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.

Re: The first open-source ventilator tested on human patients

#25
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 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.

Re: The first open-source ventilator tested on human patients

#26

Earlier quoted context omitted.

> 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 sig…

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…

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 .....

Re: The first open-source ventilator tested on human patients

#27
post #13

Earlier quoted context omitted.

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.

Medical devices and transportation sound like exactly the kind of areas that should be heavily regulated (and are in the USA as well as the EU).

No, transportation definitely is not as regulated in the USA as it is in the EU. I'm not against regulation, and you're right that medical devices should be regulated more than less, but tranportation is overregulated for nothing.

Re: The first open-source ventilator tested on human patients

#28

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

> 3D-printed?

With typical consumer-grade machines that produce garbage bathtub-toys, no.

But there's high-end commercial machines that are more capable.

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