Originally published at: https://boingboing.net/2020/04/14/tracking-and-ranking-open-sour.html
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Number of these that have (or are likely to get) FDA approval and thus will ever actually save a life: 0
I really appreciate the tinkering spirit and desire to help shown by these projects, but the reality is that a medical ventilator is a complex safety device that requires many layers of federal approval to use on humans. The FDA has relaxed some regulations for the emergency, but they are narrow and technical. For example, if a previously unapproved-for-medical-devices manufacturing facility wants to make approved parts for an approved device, there is now a fast track to get approved to do so. Another example is that ventilators previously only allowed for certain use cases, such as transportation between hospitals, are now allowed to be used in a hospital room.
The closest to anything productive is the MIT design which has applied to begin the process for some FDA approval in some particular use case, but as of this writing “we haven’t heard anything back”. It’s important to note that most of the hobbyist designs are mechanical contraptions for squeezing a portable bag, but that entire concept is not approved for the use case required to treat COVID in a hospital room. That is a long long way from sufficient to save a human life from COVID.
Medical devices are incredibly highly regulated (as they should be) and a modern ventilator is doing way more than moving some air. those hobbyist microcontroller-and-servo contraptions are not good uses of peoples’ time, however well intentioned they may be.
Just my $0.02. Donning my flame retardant suit for the inevitable onslaught now.
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might be of interest
If you want to inflate the cossts substantially, this is an option.
Phoenix man one of the first in the world to survive COVID-19 after rare ECMO treatment
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Philips has just announced an “emergency ventilator” that is significantly smaller, cheaper, and with less functions than its bigger sibling. They are intended to ventilate stabilized patients in temporary longer-term care outside of an ICU environment, such as converted hotel rooms, etc., freeing up the full-featured units for patients in need being admitted to the ICUs. Their factory is on track to produce 15,000 per week by the end of this month.
I’m not sure just how much production capacity the home-grown ventilator market will ever have (or need, given that none of them are approved for use in humans,) but all the 3D printers running in all the basements and garages of all the makers aren’t going to produce 15,000 per week.
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Of course we are a rich country. In the developing world these sorts of things might have more utility.
CPAP hackers are good … as hackers. This one is interesting, but it seems like long-shot. (Did the hidden functions software ever go through QA cycles?)
Security researcher Trammell Hudson analyzed the AirSense 10—the world’s most widely used CPAP—and made a startling discovery. Although its manufacturer says the AirSense 10 would require “significant rework to function as a ventilator,” many ventilator functions were already built into the device firmware.
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Well, some entity (MAKE) had more inventive goodwill rapportage ability in its chapter 11 pinky than the deep FDA is prepared for, that’s to celebrate on their side, right?
When it comes to being able to ship it through the ethylene oxide sterilizer unit of a hospital and hospice group, between patients say, the one made with a metal brake has a bit of advantage. Bags that will react with EtOH…kinda stiffening up.
I really hope I don’t have to (have family) stick the yoga ball inflator down my brachia, then try to bounce in my sleep. I mean that’s not even Andy Warhol Film Monster bad, but there’s will, and then there’s narrative Venn likelihood closure.
…Yes, I would have to feel sick in the first place, got some bets on that yet.
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