Risky hack could double access to ventilators
vice.com
vice.com
What most people don't know is that vents cause a lot of injuries on their own. (See ARDS). Hypoxemic respiratory failure is serious stuff, and it's almost always not the only insult we're dealing with. So, it's about balance.
In the feedback loop is a lot of things. Certainly, oxygen saturation is a core measure, but we are also thinking about things like hypercapnia (and acidosis); overall perfusion status (blood circulation); infection management; etc.
Gas exchange is important, but there are a lot of things that have to go right for the lungs to take oxygen in, get it into the right transport, and get carbon dioxide back out. You can over-optimize for any of those at the expense of the other (see: hypercapnia).
In short, it's complex and there isn't a solid formula that will work for every patient. It's actually the subject of a lot of debate on details (some of it quite passionate in our Critical care / pulmonology community). This is why we call it PRACTICING medicine ;)
The example of the Vegas disaster is different because they were all gunshot victims; they were healthy, but wounded. I hope we would never need to see if these would be effective.
All that being said in the situation where this is deployed I think it would be a risk most providers would take.
Utter respect for you and all the other medical professionals who are having to adapt and deal with this unfolding situation. Many thanks for what you do.
Could you use a CPAP machine as a poor man's ventilator? Would it be better than nothing?
There's definitely a ton of CPAP machines out there.
Ventilating people with ARDS is hard. You have to use low, carefully considered tidal volumes and essentially allow the patient to be hypercapnic (CO2 higher than ideal), sometimes quite severely. You're doing a delicate dance between ventilating in a way the lungs can take and maintaining blood gases compatible with life.
Perhaps they could get the split ventilators and the COVID-19 patients could get their own?
Presumably ventilators are a relatively niche product - what's in them that the World's industrial complexes can't ramp up production of within a couple of weeks?
I imagine it's the pumps that's the limiting factor? Given humanity already has the working tested, established designs.
Can't governments requisition the design, turn the original factories in to test only, or construct and test, centres. Instruct the mega-corps, publicly, which parts they are to make and by when ...
In the West we throw away tens-of-thousands of highly engineered products every day; surely we can step up now?
0: https://en.wikipedia.org/wiki/Words_of_estimative_probabilit...
There's an implied difference between saying something will take about 2 months vs 8 weeks vs 57 days, even if they're all technically the same amount of time.
Moving to a bigger scale, and then back down to a smaller scale maintains that implicit wiggle room.
There is likely nothing magical from a purely mechanical standpoint about making a ventilator. The part that is difficult is:
* Have an adequate QA program for you and your suppliers, tracing safety-critical components down to the raw materials
* Adjusting your tooling, making molds, etc.
* Doing low-production runs followed by testing to validate your process
* Getting whatever certification is required; even if there is a flexible emergency process, I think we still want some demonstration of compliance
* Not having the lessons-learned of companies who have been doing this for years, and have worked through enough problems to have general domain knowledge
* etc.
My experience would lead me to believe that short-term returns would better come from finding ways to optimize the supply chain and manufacturing pipelines of existing manufacturers, which potentially could be done much more quickly.
If you look at the example of WW2, when auto factories converted to war production, it was not a quick or easy affair. The excellent book Arsenal of Democracy describes the conversion of the Willow Run factory to producing B-24s, it took at least a year and a half to get the plant producing planes at an acceptable quality and quantity.
I wonder if this would be longer or shorter today with how much of car assembly is automated. How many of the tools do one specific thing a human used to? How many are robots that can be reprogrammed? That, and cars and ventilators are completely different. I'd think a ventilator is closer to a dishwasher than a car (think appliance).
Base / core machinery- such as a 3-axis CNC machine, or a lathe, or a saw, for instance, are fairly nimble- if you have the right cutting bits (which you probably do, considering that it's industry) you can switch from milling out aluminum mounting plates to milling out enclosures for electronics fairly easily. At this level, generally humans are responsible for sticking in the material and telling the machine what to do each time an action is performed.
Where it gets more complicated is at the higher levels of automation, where humans might be supervising the machines, but aren't initiating processes themselves- for example, there was a prod cell that I worked with that had a robot putting raw material into a mill and then removing it- humans program those arms, but then after that, it just goes, and goes, and goes. Programming those arms is generally an exercise in making sure the math works, and then implementing the job in a bunch of for loops and hard-coded / static adjustment variables and the like. In these instances, to make the cell produce something else, not only do you have to program the machine that actually produces parts, but you also have to reprogram the bot that puts and pulls from it, and you may also need to change the grip on the bot to support the new geometry.
At the really high levels, like how car manufacturing is currently, there are processes where metal blocks go in and a whole monoframe chassis comes out. Taking that and saying "I want a ventilator assembly" is pretty much insane- besides reworking the entire line to support the new process, you've got to wire everything up, test it, inspect it, make sure everything is up to OSHA standards, etcetera etcetera, etcetera.
Going from producing one thing with a high amount of automation to another that doesn't have any similar parts is insanely difficult. Not saying it isn't worth it, but it might be better to go to the factories that are already producing the stuff we need- ventilators, masks, respiratiors, tests- and seeing if there are any bottlenecks that could be removed.
The best way? Have enough stuff on hand to actually handle a crisis. Too bad prepping for a rainy day doesn't really align with maxing out dividends and payoffs.
https://www.welt.de/wirtschaft/article206603525/Beatmungsger...
2) With bellows (anesthesia machines)
3) Turbine, either dynamic or constant speed with a proportional valve (home use or patient transport)
4) Piston
Let's assume that we use a pneumatic device driven by centrally purified air as that is simplest. The parts then are:
-Gas blending to mix O2 and HP air
-A fast, precise, and accurate proportional solenoid valve. This turns the constant pressure into the desired waveform
-another valve for controlling exhalation pressure. Can be another proportional solenoid, alternatively a manually adjustable valve to ensure constant minimum end exhalation pressure (PEEP)
-Flow sensor (range of options, typically variable orifice or hot wire anemometer but other type exist)
-Pressure sensor (silicon waver transducer)
-Overpressure valve
-O2 sensor (highly desirable, arguably you can estimate from O2 blending settings but that will work better on a very well characterised design which this would not be. Anyway O2 sensors are widely used so this will never be a constraint.
-Piping to connect it all together
-A control and alarm system to drive desired waveform based on user settings and sensors
-Patient circuit: Humidifier / heat exchanger, patient valve (one time use), viral filters for intake and exhalation air (one time use), ET tubes (one time use)
Probably the limiting factor as far as parts go are the valves since this is a niche application.
Here's the problem: as a civilisation, if we had to make a hundred million vents by the end of the year it would be easy. Expensive, sure, but not that hard in an emergency.
It is much harder to make an extra 50,000 in a few weeks because it just takes time to turn the machinery of mass production in a different direction.
without much awareness of how much specialization goes into almost every aspect of every job. Hell, even fast-food workers-- a skilled grill operator at McDonalds -- take time to train up.
No, we cannot quickly undo the 20 years of systematic dismantling of our core infrastructure. We are in for a very rude wake-up call.
And then, once we are awake, and are dealing with our new realization on the complexity of our economy, where every part depends on every other part functioning, and trying to get this restarted with a significant number of the parts NOT working...
Then we realize that the economy is embedded in an even bigger system called "life on earth" which we have degraded and destroyed on a much larger scale than our economy.
If you think the weakness in our society which the virus uncovers are a big deal, you simply lack the full picture.
> No, we cannot quickly undo the 20 years of systematic dismantling of our core infrastructure. We are in for a very rude wake-up call.
Wait a minute. I was with you up until the end of "...take time to train up.", but I've lost the plot between there and "No, we cannot quickly undo the 20 years of systematic dismantling of our core infrastructure." To me, these seem like two extremely different issues, but it appears that you see them as being ~equivalent, or am I misunderstanding?
> And then, once we are awake, and are dealing with our new realization on the complexity of our economy, where every part depends on every other part functioning...
Agree, but I just wanted to add my $.02: Be careful when using "awake" - this is a very, very tricky word. To say it can be be deceptive is a major understatement.
> Then we realize that the economy is embedded in an even bigger system called "life on earth" which we have degraded and destroyed on a much larger scale than our economy.
I see your point, but again: for specific definitions of "degraded" and "destroyed", maybe. And even if so, does this have bearing on this particular issue? If not, it should not be part of the analysis. It confuses people, and this situation is confusing enough.
> If you think the weakness in our society which the virus uncovers are a big deal, you simply lack the full picture.
I assume you meant "...are not a big deal..."?
The equivalence between "takes time to train up" and "20 years of systematic dismantling" is that we have lost many of the experts we might otherwise depend on in a national emergency. For example, Trump dismantled the Pandemic Response Team. You can't easily replace that overnight. Longstanding cuts to CDC budgets, etc.
You are also correct that I was making a rather unexpected analogy between our current crisis and the environmental crisis. Yes, this would catch a reader off guard and cause the confusion you suggest.
Here it is again: The economy is a complex system. Each part basically assumes that the rest of the parts are there. Imagine Amazon without a postal deliver service, for example. Or your grocery store without a trucking industry.
Much of the global economy is now shut down. We will have to re-start it, which we will do, but it will be painful because of complex interdependencies between parts.
Here is the analogy: Life on earth is also a complex system. We have done our best to extract and destroy as much of it as possible. For example, insect populations are down by 80% in Western countries.
We take for granted that the natural environment is there, providing what it has always provided, without realizing how badly we have disrupted it.
Just as the US has taken good health for granted and dismantled things like the CDC, taken good roads for granted and not repaired them, taken good education for granted and demonized public school teachers (hello, Wisconsin!)....
Do you have trustworthy (confirmable), conclusive data that suggests the ideas (assumptions) in this statement are actually objectively true, and materially relevant to the actual problems we are experiencing? I've read a billion claims of this, but literally every single time I interface with the person that wrote it, the response is angry and evasive. Literally 100% of the time. Note that I'm not strongly implying any conclusions here, I am simply pointing out what I think is an extremely interesting and important phenomenon that is currently occurring on our planet, and I think there is a causative relationship between the two.
I follow your new analogy, it makes perfect sense to me, but how you connect this back to your conclusions is where you continue to lose me.
There are many companies using things like 6D CNC machines with high accuracy that can essentially spit out a part for which there's a definition (and we can 3D scan parts to micrometer accuracy with laser scanners); many electronics companies can make "any" circuit to some extent (I'm guessing ventilators use generic components, some circuits might be generic - like valve controllers, whatever, certainly display controllers I'd expect to be generic). Parts like keys, cases, outside the gas flow/control path are probably injection moulds that factories could pop out a million of within a week (once the dies are duplicated).
A skilled grill worker takes a while to train, but any grill worker given McDo's recipe could make you a functioning BigMac in an hour. I'm not asking for a new product to be designed (one effort - opensourceventilator.ie - are doing exactly that, making a modified BVM system).
Still looks like production could produce output in weeks rather than months.
It's mass automated production. Once you take the human out of the picture to get a machine to do the work you've now involved a programmer, CNC operator, roboticist. and an industrial engineer at a minimum just to get the rough task doable.
We could probably have a fully human operated production line up and going relatively quickly, but getting the machines all cut over and integrated so as to do it themselves is hard.
Look, thought experiment. You ever watch that show, "How It's Made"? They literally make entertainment out of watching the end result of the final outcome of integrating all of these stages of the fabrication process.
But if you have ever watched it, did it not strike you as interesting that they never seem to do an episode with regards to the production of the very industrial equipment automating the fabrication process?
They can't/won't because it is bloody hard, error prone, and freaking expensive. Once you've got it, you're gold, but it is by no means a short route getting there.
Large manufacturers including Vauxhall and Airbus are apparently planning to produce parts [2].
[1]: https://ktn-uk.co.uk/news/call-for-businesses-to-help-make-n...
[2]: https://www.theguardian.com/business/2020/mar/17/uk-manufact...
https://en.m.wikipedia.org/wiki/Positive_end-expiratory_pres...
The real problem will be getting actual oxygen (concentrators are not free) and people to tune the system.
But these are definitely worth looking into at least a little, since they're so much easier to make than a modern ICU ventilator.
I’m biased though: I’ve designed a 3D printed improvement on this idea that potentially allows you to ventilate multiple patients with different pressures: https://www.prusaprinters.org/prints/25808-3d-printed-circui...
Perhaps check this out as well; someone used a common valve from a hardware store to titrate pressures up and down: https://www.youtube.com/watch?v=eSVbwWANqRI&feature=youtu.be.
I've been thinking about how we might increase ventilation to one part of the circuit if the pCO2 drops too badly--any thoughts there?
I’m not sure I understand your question: do you mean if the one patient is getting hyperventilated? My suggestion is to set the pressure settings to ventilate the poorly compliant compliant lung, then use the flow restrictor to compensate on the more compliant lung.
Is there increased risk of ventilator failure with this approach? That seems like it could be an additional terrible factor to weigh, because parts have become so scarce.
It was mentioned in a blog post by an ER physician linked from hn back then.
https://epmonthly.com/article/not-heroes-wear-capes-one-las-...
Based on the specs, he estimates that a single ventilator could support up to 4 patients [0].
The bigger issue is the control system. Ideally, a ventilator will allow the patient to decide when to breath, and provide assistance; only forcing a breath when the patient fails to breath at all. WIth multiple patients, this is impossible, and you are forced to use continuous mandatory ventilation mode, where the ventilator cycles air pressure at a constant pattern regardless of what the patient is doing. Modern ventilators do not even support such a mode; although it can be emulated by programming the ventilator such that it would never detect a breath.
Another issue is doctor error. When programming a ventilator you can either program it in terms of air-flow or pressure. With multiple patients, programming in terms of air-flow is almost certainly wrong, and would cause a change in condition of one patient to negatively effect the treatment of all attached patients. This problem goes away with pressure based controls. However, if you have doctors who are used to using flow based controls, and are overworked, while using a novel treatment method, I would expect to see accidents where they either continue to use flow-based controls, or do switch to pressure based but are less effective at it due to it being yet another change from their normal practice.
Another downside is that all patients attached to the same ventilator need the same settings. You could potentially mitigate this cheaply by using analog pressure step-downs on the valves, but this just compounds the above problems, and introduces even more room untested elements to the equation.
[0] The exact number depends on how much airflow you want to provide. Apparently, in cases such as this, you actually want to provide relatively little airflow to avoid further damaging the lungs by over-inflating them.
Advantage would be that it would not require liquids of any kind and not be labor intensive.
1. Spray mask with alcohol.
2. Place in the sun or under UV light.
3. Wait as many hours/days as possible before reuse.
Seems better than re-using a highly contaminated mask day after day. I'm not an expert so I could easily be wrong though.
The reality is that we all need to have our own individual PAPR systems but we simply don't have the supplies and probably won't for weeks or months so we need to do the best we can with what we have and try to minimize the amount of healthcare workers who get sick and spread it or get taken out of rotation and place a bigger burden on the system.
Do we have more data showing they even move the needle?
non-COVID mortality is typically a coin-toss: https://www.google.com/search?q=mortality+rate+ventilators
I think early on, it was assumed ARDS was the worst outcome; your lungs stopped functioning and ventilation would tide you over.
But the more we dig in, there are multiple systems failing and ARDS is just one of many destructive processes going on.
This is one of the really important data points to work out. If almost everyone ventilated will die... it makes no sense for hospitals to extensively treat this way. Give people palliative care. It directs resources away from other, more productive efforts... for example ... running clinical trails on potential treatments to PREVENT ARDS/sepsis.
Pay everyone who contracts Coronavirus in the next 4 months and is refused ICU care, $100,000. If they die, the amount is divided between their surviving immediate family members or previously registered carer.
The current panic seems to be driven by the guilt of not being able to treat everyone. This payment should alleviate that guilt and allow us to continue with life.
https://emcrit.org/pulmcrit/split-ventilators/
It has certain disadvantages (like not being able to trigger a breath on yiur own)
So presumably in a scenario like this it's less of a problem about 'triggering own breath'.
https://news.sky.com/story/coronavirus-they-call-it-the-apoc...
Would require a modification to the mask or hose for most of these machines. (One way valve from O2 source at least.)
Once reality sets in, only the absolute idiots that don't care for being socially ostracized (or in some cases even legal consequences) will continue that behaviour. And luckily those are normally a minority.
No, the reason the top level federal government isn't doing much is because Trump is an incompetent idiot who doesn't have a second brain cell to rub against the first. The federal government has the funds and the coordinating agencies (FEMA, CDC, military and national guard) and could be buying masks, ventilators, tests; solving distribution problems; coordinating with states on social distancing and even lockdown/shelter-in-place policy. They did nothing during the early weeks when they knew it was a coming problem and it is not clear how much Pence is doing now.
As it so happens, President trump has been limiting international travel starting all the way back in January.
Why do you think the federal government isn't "doing much" (https://www.usa.gov/coronavirus)?
And what exactly would you have it do that you don't think it is doing?
Current measured growth rates are closer to 15% per day (5 day doubling time). And people's behavior changes not when people die, but when people get sick. Which happens (depending on your sensitivity) only 1-2 weeks after exposure.
But the basic principle still applies. We are trying to buy as much time as we can to ramp up emergency provisions. And are trying to avoid overwhelming emergency rooms. By the time people's behavior modifies through direct experience, it is too late.
Making this concrete I live in Orange County, CA. Population, 3.3 million. Hospital beds, 6600 (source https://www.hasc.org/orange-county). I don't know how many ICU beds, but https://www.accjournal.org/journal/view.php?number=630 suggests it likely is about 6% of the total. So about 400ish.
Now walk that backwards. 400 people in ICU beds probably means 4000 people with symptoms means less than 0.1% of the population with COVID. Except that it is worse than that. We have those beds for normal stuff that goes wrong. They aren't actually empty now.
Long story short, we start piling up excess dead bodies due to lack of capacity long before most of us personally know anyone who actually shows symptoms.
Citation needed. In the US, via Wikipedia:
https://en.wikipedia.org/wiki/2020_coronavirus_pandemic_in_t...
2020-03-17 5656 infected 96 dead
2020-03-19 11980 infected 172 dead
That's doubling time of 2 days, not 5. When was it 5 days the last time? If that 2 days continues, in two weeks: 1.5 million infected, 22000 dead. Also, the data across the world show only: the typical doubling time once it really starts going is 3 days, never 5, at least without the beneficial contribution of lockdowns:Italy dead:
2020-03-16 1809
2020-03-19 3405
It's 3 days doubling time there, and they started to quarantine municipalities since February 22, and locked down the whole country on March 10.https://en.wikipedia.org/wiki/2020_coronavirus_pandemic_in_I...
Netherlands dead:
2020-03-16 24
2020-03-19 76
Doubling time faster than 3 days there. Not much of measures.https://en.wikipedia.org/wiki/2020_coronavirus_pandemic_in_t...
So "the risky hack" this article is about buys one not more than 3 days under the circumstances.
Speed of deaths is a good indicator because the number of those who die and those who need an intensive care unit are very close.
A lot of countries aren't able to test as much as it would be needed, so the number of "verified cases" which have less serious symptoms tends to be lower than the actual numbers. But those who die and could have been exposed to the virus and have matching symptoms are more consistently tested.
Main point: the US data can't be considered in vacuum, we know much more than US was able to test due to their botched procedures. But across the world, it's nowhere 5 days, as soon as the number of dead is more than a single digit.
Measuring what is going on by confirmed cases measures ramping out of testing more than the actual growth of the virus. Death figures are likely to be more accurate. But note that we expect it to take 3 weeks before quarantines show up in fatality figures. (A week for exposed to get sick, 2 more weeks before they die.) Therefore Italy shouldn't yet see the benefits of quarantines.
topic of which isn't the evaluation of the recorded growth across the world, but to show that lax measures are problematic even using the slower growth rates.
They specifically write just:
"Infection was assumed to be seeded in each country at an exponentially growing rate (with a doubling time of 5 days) from early January 2020, with the rate of seeding being calibrated to give local epidemics which reproduced the observed cumulative number of deaths in GB or the US seen by 14th March 2020."
That's what they use in their model to demonstrate the point.
They never claim it's accurate or quote any sources for that number, because they just use that very "optimistic" value for the demonstration purposes: to show that even with that number, it's not reasonable not to implement serious measures. That's how mathematical proofs are constructed: you construct the lowest bound which doesn't have to be accurate, just to be obviously lower than the actual numbers, and show that even then some assumption doesn't hold.
I'm claiming here that that is not a "current measured rate."
> But note that we expect it to take 3 weeks before quarantines show up in fatality figures.
That's why I've stated about Italy: "they started to quarantine municipalities since February 22." It's not that they let it waiting for "herd immunity" like UK or NL. It was less than 4 weeks ago.
2020-02-22 2 dead
2020-03-19 3405 dead
with 3 days doubling time they would have today 2048 dead. It doesn't appear to be possible to be slower than 3 days. With 5 days doubling time they would have now just 128 dead, with 4 days doubling time 256 dead. It's that easy to calculate.That's the Italian "current measured rate" for a month now.
References such as https://www.imperial.ac.uk/media/imperial-college/medicine/s... have used a doubling time of about 5 days. As https://www.statnews.com/2020/03/10/simple-math-alarming-ans... points out, studies of what happened in Wuhan suggest a real doubling time of about 6 days.
There are admittedly a lot of question marks about everyone's numbers.
Previously it has been communicated that 99% of deaths are to people with existing health problems.
https://www.reuters.com/article/us-health-coronavirus-italy-...
There are two people in my life I expect to die of the virus: my sister who is in her late 20s, with a lifetime history of Anorexia/Bulimia, who is currently in stage 5 kidney failure. Secondly my Aunt, a lifetime smoker, who currently has terminal lung cancer.
Both of these people, speaking personally, are going to die sometime this year. Will their deaths be accounted against the Coronavirus death toll or to their underlying conditions?
Is there any point to shutting down everything for 18+ months so that they can live another few months, doing so under lockdown conditions and general panic, with nobody able to visit them? And at the end of it all, many of the people who care for them will be unemployed.
Hash tagging #coronavirus #wfh on a photo of a table full of food and 65" TV with Netflix makes it sound like a party.
* not tested in humans
* cross infection potential
* different sized people mess it up
... but I see no reason why any of these things would stop me from using this in the real world. If things are bad enough that we need to do this, then we should be able to find relatively similar sized people. Cross contamination is not a concern when someone is dying here and now and likely has the same disease as the guy next to him who is also dying. Priority 1 is save them. Make their next of kin sign a waver or something, but save them. Lastly, who cares if it hasn't been "tested"? It was used in the real world, in a real life and death scenario, and it worked. I'd absolutely take my chances with it given that the failed option is to pull people off and set it back to single person mode. At least try.Lastly, I would imagine that some common pressure regulation values could be used to compensate for different sized people.
If COVID evolves into multiple strains, then there is a real risk of cross-infection that would make the immune system forced to work harder? Moreover, a lot of the pneumonia deaths are not due to covid itself but rather due to opportunistic infections (often bacterial) that end up causing the pneumonia that causes death. Letting two COVID patients share a ventilator could mean that now one is exposed to a novel bacteria in the other that causes them to develop pneumonia.
I'm sure they can figure out how to re-use ventilators, but there probably needs to be some kind of assurance so that things can't cross.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
The Ventilator just keeps them alive for a few days, but there are other bodily systems failing and causing death.
Most simple pressure regulators will not fare well in the environment, either, because of the bidirectional flow, etc.
The "Y" hack definitely has use, but finding matches and keeping patients matched definitely means we will only be able to use it sparingly.
https://emcrit.org/pulmcrit/split-ventilators/
Continuous mandatory ventilation (CMV) is required, however it is necessary to accept permissive hypercapnia.
Good on them for trying to save human lives, but our legal system does not always reward the ethical behavior.
Our laws are not a suicide pact and sometimes they must be broken.
I’m not qualified to assess whether this risk is worth it but I am surprised that Vice’s editing is so shoddy. It certainly doesn’t engender faith in the veracity/accuracy of their reporting.
And also "Babock".
It’s unfortunate, because their reporting seems to be quite good.
of course you don't want to
but in italy, fatalities increased because there aren't enough ventilators.
US is days away from that point
so if it's a matter of no ventilator or a dirty ventilator, most people will take the dirty vent.
after all: the sanitary crisis is for Coronavirus, and you already have it.
https://en.wikipedia.org/wiki/Robert_Liston#Liston's_most_fa...
F! This solution might be worse than the disease.
Hacks are ok with web and app deployments where you are able to patch and fix to your heart's content and the damage is not life threatening.
I have worked with the medical industry, the amount of formal validation and verification that goes through on software is insane compared to what we have in the "move fast and break things" world.
Even if it is "temporary" and "desperate" I would stay away from this mentality as much as humanly possible.
Just like you would use a sweaty t-shirt over an open wound in a life or death situation if there is no certified sterile bandage at hand. The calculus is different.
Different circumstances with different levels of risk, require the ability to adapt.
Nobody is suggesting 'sharing ventilators' would be normal practice because in normal circumstances we want to make sure that equipment is 99.999% reliable.
But as you imply, this requires extensive testing and regulation. Within these regulations are also significant safety margins that can be exploited if conditions change. If we can multiply the usage and maintain 99.99% reliability, then this is probably a risk worth taking.
Also - if you've worked in the medical industry, you know how vastly overpriced and bureaucratized everything is.
The situation of 'not enough ventilators' is literally happening right in front of us, and it is causing death.
The risk tolerance for utilizing the gear in such a manner is such that it may very well be possible to create better outcomes.
The individuals involved are medical practitioners who are well versed in the equipment, procedures, and inherent moral dilemmas, they're not fools.
This is exactly the kind of procedural innovation required in times of crises - hopefully, a few doctors and especially the Engineers from the manufacturer can be involved. The people who built the gear may be able to give a much better articulation of the actual risks involved, and they may even be able to mitigate, for example 'the risk will be power consumption' or 'the risk will be this specific valve which could wear and break' thereby implying the 'new operational procedure' would involve daily checking of said valve etc..
The world is facing crises we absolutely must be adaptive while trying to quantify risk and outcomes.
Quality guy here,though not in medical devices... Yet. Still trying to get up to speed on all the regulations; but I know enough to be able to vouch for some of the bureaucracy around the industry.
The risks in medicine being what they are, when launching into any novel space, there is simply no substitute for A) data and B) audit trail.
Your data varies from lot numbers of source material from suppliers (contamination happens), batch numbers of parts (and revision numbers of the process involved in making that batch) from manufacturers, to serial numbers matched up to individual patients in order to be able to implement some form of high-level statistical process control, and rapid intervention when things go wrong in order to figure out why, what you can do about it, and who else may be at risk. No one wants to be the one told "whoops, someone goofed, and that thing we put you on is trying to kill you," anymore than anyone in the chain from treatment inception, to installation wants to hear that they missed something, and even worse, get caught not knowing what to do about it.
That means paperwork, signalling mechanisms, and procedures involved with marshalling whatever response is to follow, which is not at all a trivial process to orchestrate, and while all of us wish there wasn't so much bullshit, there are plenty of examples where "falling asleep on the job" has led to catastrophic outcomes.
I can't necessarily say I that justifies the overriding though. The markups are ridiculous, but without access to the books, I can't really discount it either.
You don't seem to be reacting to the situations that the idea addresses, situations where there is an immediate shortage of ventilators.
As of about 48 hours ago Lombardy's hospitals were not turning anyone away:
https://www.cnbc.com/2020/03/19/italys-death-rate-reaches-re...
Medical facilities in Lombardy will “soon” be unable to help new coronavirus cases, regional Gov. Attilio Fontana said Wednesday, as he urged everyone to stay at home.