Challenge to Pelican Engineering -> Let's design and build an open-source Ventilator!

[Mahler9th]

I work in this field and have vast experience.

Even with federal laws in a relaxed state due to a pandemic, the lawful design, development and commercialization of a new type of ventilator would take years... not months. Cannot take shortcuts on that.

You can be certain that folks are working hard on making more equipment available as fast as possible-- both in government and in the private sector, including the related supply chains.

You can also be sure that it isn't only vents... it is a host of equipment and related supplies that are used and/or consumed in ICU care settings.

For example, what good are 100k more vent systems if we don't have enough disposable vent circuits? And those circuits must be changed at regular intervals, for example, to lower risks associated with hospital acquired infections.

I am confident that expert folks are highly motivated and working on these challenges.

Sidebar little "world is small" Porsche-related story...

A couple of years ago I was in Sarasota working on a consulting project for a well known Japanese company. We had a design firm down there helping us and I was meeting with them and some of their associated consultants.

The design company and one of their consultants (an EE) had some experience with medical devices and equipment, but we were working on a consumer product concept.

Over lunch, I probed the design consultant on his experience in medical, and he told me that his brother, a Ph.D was in charge of ODE at FDA. ODE is the part of FDA that manages the clearance and approval processes for medical equipment and devices! I first dealt with ODE back in 1987, helping to bring a new type of $1M medical system through approval. Lithotripsy system

In parallel, my buddies were doing the same thing for the first MRI systems. So we had a lot of dealings with ODE.

So now it is 2017 and I am sitting next to the brother of the fellow that runs FDA ODE. My heart was pounding.

Our conversation turned to hobbies and interests (again, we were at lunch) and I mentioned auto racing.

The EE asked if I ever heard of IMSA. I said yes of course.

He then said he once worked as an IMSA tech inspector at a race at Sebring. In the 70's I think. I asked about the circumstances.

He said his (I think at the time ex-) college roommate was running IMSA tech and was short handed so he got pressed into service.

I asked what his name was, by then knowing how the story was likely to turn out.

He said, "Mark Raffauf."

Well Mark and his brother Martin are very close friends with Porsche icon and my friend Jerry Woods. I am pretty sure that both of them were involved with Garretson/Barbour back when they were running 935's as the de facto Porsche factory team running out of Mountain View. Jerry Woods worked there under Bruce Anderson.

You can read a bit about Mark here:

https://racer.com/2019/01/19/my-racing-life-and-career-mark-raffauf/

Incidentally, that interview was conducted by Marshall Pruett, a friend to us Porschephiles who lives right here in Fremont.

The world is small.

[Won]

Thanks for the insight Mike.

What exactly is this printed part? Looks like a one way valve? Why do they need to be changed every 8 hours as per the BBC article?



If these things do in fact get used by hospitals, I think it just highlights how desperate the situation is. That's SLS printed and absolutely the worst option for hygiene/sterility.

Maybe things work differently outside of the US? Why else would the government ask for help? Surely even the supply chain must be certified otherwise.

[Mahler9th]

The laws in place regarding medical equipment and devices are well known to me-- perhaps not many of you. At the center are safety and efficacy.

Some of the laws have to do with proving safety and efficacy sufficiently to obtain an FDA clearance or approval (which one of these applies depends on a number of factors-- new types of vents are likely in need of clearance).

Others have to do with process-- the manufacturing process, which in itself may require approval(s) before anything can be sold and used on a patient.

I can envision the potential for some relaxation of legal/regulatory structure for the manufacturing of some types of devices and equipment in the face of a global pandemic... so for example if we needed more tongue depressors, I can envision a relaxation of manufacturing requirements (yes those simple things are medical devices by law).

But for others, like vents, I see a rockier path toward relaxation of US laws and regulations-- especially with our legal system.

In some ways these machines are simple, and in other ways they are complex. But the safety and efficacy of vents is absolutely critical given how they are used in healthcare. So relaxing any laws and/or regulations regarding design and/or manufacturing is likely fraught with peril.

So in this country at least, it is hard to envision a relaxation with respect to machines like vents.

But at this point I would not be surprised... this is all new territory. And some of this new territory may require new laws soon or eventually.

[Mahler9th]

See, e.g.:

https://www.qualio.com/blog/fda-medical-device-classes-differences

[Mahler9th]

Related stories:

https://www.nbcnews.com/news/world/coronavirus-ventilator-rush-faces-regulatory-logistical-obstacles-n1161651

https://www.mercurynews.com/2020/03/17/covid-19-hospitals-fear-a-shortage-of-ventilators/

[Mahler9th]

By the way, I started with medical devices and cap. equipment in 1978-- summer engineering job with GE healthcare in my home town, Milwaukee.

People in my network created things like pulse oximetry and CPAP and CT and MRI.

I am certain these folks are turned on and tuned in globally.

[Mahler9th]

But again, don't forget about the associated disposables, personnel et cetera.

And even the little things-- the governor of Rhode Island was interviewed on TV today and she was concerned about shortages of swabs for sample collection (part of the testing process of course- it is not a test, it is a process). She has been trying to get answers from the federal government.

Cotton swabs.

[wdfifteen]

Originally Posted by Won

But then, you would need to meter the air both ways so you don't over-inflate or over-extract?

Does anyone here know?

All I know is if the CPAP pressure is too high the next day you fart like a cow.

[Mahler9th]

From 2017:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443457/

I am sure the literature is replete with similar examples.

Folks are motivated... I think it is clear that we have to work these challenges from BOTH ends, and that seems to be happening.

[Mahler9th]

Excerpt from that publication:

"An important aspect of interpreting the results from the model of Huang et al. is the problem of expected unmet demand. There is an upper limit to the number of additional ventilators that any hospital can absorb and use to successfully help treat acutely ill patients needing mechanical ventilation. This limit is determined in large part by the number of trained staff—particularly respiratory therapists, nurses, and technicians—available to ventilate and monitor patients (6). That is, the number of machines is less of a constraint than is availability of trained personnel. Huang et al. allow for expected unmet needs, setting a default value of an acceptable level of 5 patients unable to receive mechanical ventilation at any given time. Assuming a moderate, 2009-type influenza pandemic, the authors estimate a 30% chance of this expected unmet need occurring. To meet this level of unmet demand in Texas, planning for a moderate or a severe pandemic requires stockpiling as few as 1,172 or as many as 15,697 ventilators, respectively. However, actually deploying and using such high volumes of mechanical ventilators would be challenging in terms of having enough hospital space and staff to support additional ventilator use. Thus, during moderate and severe pandemics, a higher level of unmet demand might need to be expected. Attending physicians will have to determine who gets access to the limited number of ventilators and who does not. Only a small number of studies describe how physicians might make such allocation decisions for critical, scarce resources (i.e., triage or prioritization) and how they would explain such decisions to the patients and their families (7–9)."

Well here we are...

[Mahler9th]

Maybe think about it like creating a WWII US warplane (excluding, e.g, modern design and prototyping capabilities, induction and enlistment).

Class 3 medical devices are like airplanes.

Maybe it makes more sense to help build them than to create our own design and manufacturing. Or to volunteer to take care of the kids of the folks that build them.

Some stayed home to take care of the kids. Some were Rosie's. Some did both.

Many people did many things. I like to think that the same type of culture is rapidly developing here and now. Globally.

[pavulon]

Every year, thousands of anesthesia machines are replaced and most of the old machines go to scrap yards. Integral to each machine is....a ventilator.

[john70t]

Human lungs are 1-1.6 gallons.
Use something common like a 5gal bucket.
Print a plunger/rod/crank. Glue some kind of seal.
Use some kind of very standard motor at 20rpm?
A check valve that opens to a tube/mask at a certain pressure to creates a burst of flow.

(Maybe too much new engineering required and not sterile)

[unclebilly]

Originally Posted by Mahler9th

The laws in place regarding medical equipment and devices are well known to me-- perhaps not many of you. At the center are safety and efficacy.

Some of the laws have to do with proving safety and efficacy sufficiently to obtain an FDA clearance or approval (which one of these applies depends on a number of factors-- new types of vents are likely in need of clearance).

Others have to do with process-- the manufacturing process, which in itself may require approval(s) before anything can be sold and used on a patient.

I can envision the potential for some relaxation of legal/regulatory structure for the manufacturing of some types of devices and equipment in the face of a global pandemic... so for example if we needed more tongue depressors, I can envision a relaxation of manufacturing requirements (yes those simple things are medical devices by law).

But for others, like vents, I see a rockier path toward relaxation of US laws and regulations-- especially with our legal system.

In some ways these machines are simple, and in other ways they are complex. But the safety and efficacy of vents is absolutely critical given how they are used in healthcare. So relaxing any laws and/or regulations regarding design and/or manufacturing is likely fraught with peril.

So in this country at least, it is hard to envision a relaxation with respect to machines like vents.

But at this point I would not be surprised... this is all new territory. And some of this new territory may require new laws soon or eventually.

For the record, if things go badly for me, I would rather have a functional vent than not be able to get access to a FDA approved vent.

The purpose of this thread is to develop something for use in an emergency situation, not something for used or sale on the open market in normal circumstances.

[HardDrive]

Originally Posted by unclebilly

For the record, if things go badly for me, I would rather have a functional vent than not be able to get access to a FDA approved vent.

The purpose of this thread is to develop something for use in an emergency situation, not something for used or sale on the open market in normal circumstances.

This.

That was a great Porsche story. Snore.

I 3D print. My wife is a physician. If we rope something together using tubing from HD, and printed valves, are you suggesting that governmental approvals will be relevant?

[Mahler9th]

Cold water is cold by definition.

I did not know the intention was to, for example, create a design for one to use on one's loved one(s). In that case anything goes.

If we get desperate enough, folks with "health care basic knowledge" may start providing intensive care to folks close to dying with crude tools and methods that may not be safe or may not be effective or in between.

Regulations and laws and litigation will not matter anymore...

I wonder if that is going on in Italy? Aren't they desperate? Don't they have engineers and 3d printing machines?

It has not been my intention to pour cold water on Wayne's idea. I would hypothesize that many others are discussing things like this all over the world using social media tools like these Forums.

We know experts are working to increase production... lots of articles on this and I posted a few links.

I hope that folks can see the bigger picture, that there are myriad resources which must be considered, for example trained folks to provide care.

I hope that folks can focus energies and enthusiasm toward efforts that science suggests are potentially much more impactful in the near term.. In my opinion, by the time we get to cobbling and monkeying around in "an emergency situation," other factors will likely be be in play.

Likely enormously powerful and very, very unpleasant.

Like who gets professional care and who does not... challenging.

How will Sutter Health decide?

How will the Mayo Clinic decide?

Based on insurance coverage? Socioeconomic class?

How?

All that being said (and asked), I fully recognize that part of what goes on here is that some folks are "working through" the hard realities of our situation. Our global situation.

[Mahler9th]

From the link provided by Wayne:

"Many health authorities are preparing for the possibility of a flu pandemic in the next few years.
If a pandemic occurs that is related to the type of virus that is currently spreading in birds, they fear that it may be as bad or possibly worse than the 1918 Spanish flu pandemic. It is expected that the number of people that require treatment with ventilators may be much greater than the current number of ventilators in existence. If a pandemic were to strike, the hospitals could not just go out and buy all the ventilators they need, because there would not be enough parts or manufacturing capability. Many governments already have plans for triage and rationing programs that will determine who gets access to the limited number of ventilators and who will be left to die. When I first heard about this, I thought, "This is not good enough, if someone I know or love needs a ventilator, I would get one, I would build one myself if I had to". Thus the idea was born."

I see no date on the article.

Nosotros veremos.

[93nav]

I agree, and that is what some groups are planning for.

Originally Posted by unclebilly

For the record, if things go badly for me, I would rather have a functional vent than not be able to get access to a FDA approved vent.

The purpose of this thread is to develop something for use in an emergency situation, not something for used or sale on the open market in normal circumstances.

[unclebilly]

So why are the asco valves needed? Couldn’t a simple vent be built with a diaphragm and a couple check valves?

I’m thinking control the speed of a dc motor with a pot (or cheap vfd on a 3 phase motor) and have a crank shaft with an adjustable throw to set the displacement.

[Mahler9th]

Related link:

"Pandemic Ventilator Project "

https://panvent.blogspot.com/2020/03/how-lethal-is-covid-19-and-will.html