I sincerely hope that the MIT project is just an exercise in over-preparedness, and that enough "real" ventilators will be made in time, but it feels to me like they could be needed in huge numbers before they are able to be mass produced.
If there are not enough approved ventilators for everyone that needs them what will happen when a hobbyist tries to present their DIY ones to a hospital? The hospitals/patients need to have the authority to make the decision on wether or not to risk using a non-approved device. As long as the device has a reasonable chance to increase survival rate and a low chance at reducing it, then logically they should be allowed to be used when all other options have been exhausted.
I think it is a very plausible scenario where family members will be outraged over a hospital's refusal to allow DIY respirators to be used.
I suspect that in this circumstance, they would waive some strictures. We have way too many regulations for our own good. I wish they would waive a lot of food safety laws so that we could have lower-key places to eat. Where I live, there ought to be all kinds of roadside stands to eat locally grown foods, but by the time you jump through all the hoops, you've got the same uninteresting experience to offer as everyone else does, plus you're broke. Boring. Why even bother? That's why it's fun to go to Mexico or Thailand - more local food on a lower cost basis, more adventure. America is boring when it comes to eating.
Hope to god not when it comes to medical devices. As the parent of a special needs kid, you would not believe the amount of shyster devices and systems that are out there. A few gears ago, there was a device for autism treatment of no value, no clearance as a medical device, and I would bet some were sold before the FDA raided them. I called it the Lean Mean Shocking Machine. Can you imagine what is already being seen now? Check out the class I recalls. These are almost all from reputable firms. Consider the. consequences of a less regulated system......... Bad food may burt you and maybe a few others, but a medical drug or device failure can harm a lot more.
Whatever happens to an individual person: the great picture is: if a complete population is effected, about 1% will not survive That's a huge number and will bring down the average life time by 1%.
We see now what happens in a highly optimized world where all resources are used to the maximal level and where is no headroom for self healing processes. We had such situations all the time and there always were stand by systems that could fill a gap. This is no longer the case. So we have to realize: there is no Plan(et) B. But I fear, if the prize for my soul is 1200$ cash and 3500$ for a more save car, there is no place for hope. Science is hard work. https://who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf Like this. Imagine the fight for the P2. Next generation will just see a unique system but not the blood, sweat and tears behind it.
So let's just hope! And be careful and responsible.
Hope to god not when it comes to medical devices. As the parent of a special needs kid, you would not believe the amount of shyster devices and systems that are out there. A few gears ago, there was a device for autism treatment of no value, no clearance as a medical device, and I would bet some were sold before the FDA raided them. I called it the Lean Mean Shocking Machine.
That is quite a bit different. Ventilators are proven devices. They actually work. I think that hospitals should be able to make the decision on wether or not to use a DIY ventilator - obviously they would turn away devices that did not meet certain criteria...
If you found yourself in a situation where there were no more commercially made ventilators and a loved one of yours was denied treatment, would you then be okay with not being permitted to make use of a working DIY ventilator? Imagine that a skilled individual had made one (it worked) and was offering it to be used.
A short Google search for "ventilation corona mortality" results in about 405.000 results (0,41 seconds) including a link to this paper: https://physiciansweekly.com/mortality-rate-of-covid-19-patients-on-ventilators/ This is sophisticated clinical technology! Sorry: this is the truth, at least it seems to be close to the truth. If the president talks of "war" we have to accept that "war" is not an easter promenade, or as he would likely say: an easter stroll. It's just cruelty.
Stay all save, and hope for a person to create a vaccine, no matter where and how great his or her country may be.
A short Google search for "ventilation corona mortality" results in about 405.000 results (0,41 seconds) including a link to this paper: https://physiciansweekly.com/mortality-rate-of-covid-19-patients-on-ventilators/ This is sophisticated clinical technology! Sorry: this is the truth, at least it seems to be close to the truth.
I only get 388,000 result for the exact same Google search...
I cannot tell if you are in favor of, or against the DIY ventilators.
There are "open source" ventilators such as the Medtronic one where they have made available all the documentation for a well equipped factory to reproduce their FDA approved ventilators - with a very restrictive license. Not a DIY respirator for sure. If factories can get spooled up in time to churn them out then that is a very good thing. Probably, a factory would have to use exactly the same parts as called out in the designs in order to be able to have it certified for use. I think it very unlikely that sourcing large quantitates of very specific components is something that could happen it a short time frame. Substitutions would greatly increase the work/time required to get it FDA approved.
Then there are the open source ventilators such as the one being developed at MIT which are simple (but functional) devices intended to be easily manufactured by any skilled person. I think I have everything required to make at least a couple of the MIT ventilators - I would need to adjust the power transmission portion to match what I have on hand but that is within my capabilities. I'll bet a lot of 'makers" such as myself would be able to make them. It would be a very sad situation if we had the ability to construct devices that would save lives but were prevented from doing so due to regulations. Regulations that should be relaxed during times of crisis.
In the US, there is a... not sure what to call it, but there is a general rule where it is permissible to break the law when doing so preserves life or property. Use of an unapproved medical device when no other is available to help save a life should fall within that rule.
What we experience now is not a movie. It's real. Apollo 13 was real and a realistic movie. Showed: individuals can change a game. A single person counts. But we all know what mass production means and know fully automated assembly lines. In setting up such a factory, skilled people are needed and every person counts as does personal ingenuity. But in running a site, every single person more or less has to be a robot and there must be someone to replace him seamlessly. The problem with supply of ventilators is how to ramp up production. And that is a question of tooling available, like moulds for injection moulding. There are plenty of CNC controlled milling machines. No problem to load programs, but fixtures may be needed. So this is the time for tool makers of any kind, which we now find close to the manufactures, that mostly are located in Asia. Fighting a pandemia is a global task! Watching a briefing at late night, trying to understand what happens to the US is very close to masochism. I can assure all the forumistas: the internet is running perfectly in Germany (not worse then normal ;-) ) and we know the sea level of Seoul, if we Google ;-)
We all are here together because we know, for different reasons, the Propeller is just a superior microcontroller! We are proud to know a person which is humple enough to share his spirit. And I personally grab every Propeller I have the chance to!
And: regulations are a two sided sword: they can protect a monopoly or they can equal chance like on Golfing. It is okay to cut away a hand of you are clamped between stones, but that is not the way it should happen. Lawsuits only create income when there is overflow. But this all seems to be very complex and I should better go back to work ;-)
What we experience now is not a movie. It's real. Apollo 13 was real and a realistic movie. Showed: individuals can change a game. A single person counts. But we all know what mass production means and know fully automated assembly lines...
Please forgive my inability to properly interpret what you have said, are you in favor of skilled individuals constructing MIT respirators or not?
No. Exponential grows of cases is a question of the time line. Imagine a town with 38 million inhabitants. Thats about 2^25. If the number of infected people doubles every day, it takes 25 days the have 38 million cases. This exponential law may be valid until half of the population is infected. There will be lack in everything: material and staff.
If the time scale is 1 week it will take 25 weeks. So what helps is social distancing, testing and isolation positive people and research. Personal genomics today is state of the art. The technology to produce tests or vaccine in masses should be available, we have to search for a blueprint. If the death toll is in the low percentage and only every second patient can survice ventilation, this indicated having ventilator or not doesn't make a large difference. If we want to do something for those in danger, we have to follow the advice of the scientists. The economy will recover, no doubt. This is not a war with all the destruction. This to me is just a warning.
Yes, cannot tell if it was for PR or to be legitimately helpful. The license is restrictive and temporary, the parts will be very difficult to source and any changes will make getting FDA approval much more difficult. If some other capable factory was going to manufacture a respirator for this crisis, they would have to cease making them after the crisis was over or they would be in violation of the license - if they used any of Medtronics data to develop their own respirator. I don't know if any company capable of making these machines would choose to do so within the limitations of that license.
Hope to god not when it comes to medical devices. As the parent of a special needs kid, you would not believe the amount of shyster devices and systems that are out there. A few gears ago, there was a device for autism treatment of no value, no clearance as a medical device, and I would bet some were sold before the FDA raided them. I called it the Lean Mean Shocking Machine.
That is quite a bit different. Ventilators are proven devices. They actually work. I think that hospitals should be able to make the decision on wether or not to use a DIY ventilator - obviously they would turn away devices that did not meet certain criteria...
If you found yourself in a situation where there were no more commercially made ventilators and a loved one of yours was denied treatment, would you then be okay with not being permitted to make use of a working DIY ventilator? Imagine that a skilled individual had made one (it worked) and was offering it to be used.
Yes, my example may be different, but it illustrates one of the most important reasons for the FDA's involvement in medical device manufacture. No device intended for medical use is a proven device until approval. And that is not always a guarantee. Problems could still show up after release. Severity of a recall is indicated by the class of the recall. Class I recall is really not an optimal situation. You could design the most capable, safe, etc ventilator in the world, but unless it has been tested and approved, it is just another device. At least in many of the more advanced countries in the world. That is the only real defense (and at times questionable) against the charlatans and snake oil sellers. And those who mean well but do not know enough to know that they in no way know enough.
Unless Medtronic supplied every assembly and part, the company cloning the Medtronic ventilator could not prove it was identical in every way to the FDA cleared device itself. Also given the age of the released materials, did Medtronic also release any FCOs with the plans? If there were any FCOs how critical were they? There is usually a good reason to go through the process of modifying an approved and released design. Corrective action post recall?
As to your last example, I pray it's a choice that will never happen. How does one define working? It blows and sucks air, but will it cause permanent damage to the lungs resulting in a crappy quality of life if it does not kill the patient outright. I also believe that we will run out of the trained personnel to apply these devices long before we run out of ventilators as the supply of machines increases. Takes time to train up a Respiratory Therapist, seems a 2 year degree with clinical experience is the minimum to sit for certification. Even more in some states and for advanced certifications. So, who is offering open source training on that one?
We (the world) got caught out. How far back do we go? "The Stand", "Andromeda Strain" or any number of low budget doomsday movies and novels, and no one believed it can happen for real (maybe some preppers?). We set up the various levels of agencies to prepare, blew lots of money on "studies" about how this sort of thing may happen but did nothing with the information and ended up in the spot we are in now. So in reality, the governments at all levels should have been better prepared than they were.
So much to rant, so little time and space. My job is to keep medical imaging systems running, so in that small way, I continue to contribute whatever I can to support the ones who depend on these things.........
Yes. Whatever one can do. I run a small business with few people where every single person is undispensable. But every week one half stays at home, as I decided that this will reduce commutation of possible viruses by a lot: form graph theory we know that increasing the number of nodes increases the number of possible edges by a high order. That is what everybody can do for sure: calm down, act as if there were a catastrophe in place and be happy, that not the children are affected first.
And, as running idle, switch on the NI-system and think about why something like this can happen. Singular systems, when failing, are fatal. The wind alway blows somewhere. The more energy is collected in distributes places the more stable the system is. Necessary grid connections are expensive, give you as a side effect more stability, reduce transportation losses, ... Being a child I wanted not to be a pilot or firefigher, I wanted to make nuclear power plants to create energy at no cost in any amount. Grown up I realized that energy is available in any amount at very low cost and nuclear power has proven to destroy everthing that was build up by generations, while some say we have to run those facilities just to keep our standard of living, knowing very well, that this can not be rolled out to the rest of mankind.
What is the reason, that when I work with other nations, politics is off limits? What do we have to hide?
As to your last example, I pray it's a choice that will never happen. How does one define working? It blows and sucks air, but will it cause permanent damage to the lungs resulting in a crappy quality of life if it does not kill the patient outright. I also believe that we will run out of the trained personnel to apply these devices long before we run out of ventilators as the supply of machines increases. Takes time to train up a Respiratory Therapist, seems a 2 year degree with clinical experience is the minimum to sit for certification. Even more in some states and for advanced certifications. So, who is offering open source training on that one?
I would define "working" as meeting the specs defined by the MIT project.
The discussion on wether or not DIY respirators should be allowed is only relevant if that choice becomes a reality. For purposes of this discussion let us assume two things;
1. There are not enough approved ventilators to treat everyone that needs them.
2. There are DIY respirators that meet the MIT specs that are available, but they are not approved.
Hoping and praying that the described situation never occurs is irrelevant with respects to this discussion.
The point about not enough trained therapists to operate the respirators also applies to the approved respirators. It is the same problem regardless of the approved/not approved status of the machines.
The point about an inferior respirator saving a life, but that life having a poor quality... well that is a decision for doctors, patients and families to make. The availability of an DIY respirator does not make that a necessary outcome. From what I understand about the healthcare field, the priority is to preserve life.
There are different points of view when it comes to "working". An accident mostly is originated in an unexpected behavior of a technical system. For example the cooling fan of a automotive motor today is driven by a switched speed regulator. A car suddently burns out. There is a little leak in the housing of the regulator to serve as a pressure vent. This leak is covered by a piece of goretex. If this little element is not glued perfectly, water vapor my enter, condense, electrolysed, the hydrogen is collected and so the fire ignited. The moment the car burns the whole car production line is stopped until the error is located. So a car is working if there is less than one error in a million of parts delivered! In the special case of Corona a ventilator has to work for 14 days. Thats not just an hour to survive a critical moment. A defibrilator is approved to apply a certain number of shocks. That makes them bulky and expensive. In reality you do not want to live if more then 2 shocks are needed to restart your heart after a sudden cardiac arrest. So it could be better to have low power defi's and have them omnipresent. But they are not approved.
Again: when it comes to the situation that so many ventilators are needed, there is no room for diy equipment.
The point about not enough trained therapists to operate the respirators also applies to the approved respirators. It is the same problem regardless of the approved/not approved status of the machines.
As a retired critical care RN I often had to adjust vent settings. The RRTs are the absolute experts on this, even the pulmonary intensivist physicians would seek out their advice. Push comes to shove sometimes a short phone call from an RN to an RRT or intensivist works just fine. Communication is key. That said, there's nowhere near enough RNs either. The insane drive to save money by the suits over the past several decades was and is endangering patients who expect the best - but that's a discussion not germane to the current subject nor appropriate for this fine forum.
Again: when it comes to the situation that so many ventilators are needed, there is no room for diy equipment.
I honestly cannot see why there is resistance to using a DIY machine (when it is the only option). Again, this DIY machine is not something that Homer Simpson would make. It is a machine built to meet the requirements laid out by the MIT team - which are the minimum features and capabilities required for FDA approval.
Obviously no one would choose a DIY machine over an approved one. Why would you refuse a functional DIY machine when the only alternative is no treatment?
Law firms and the propensity for people who have lost a loved one to look for something to blame would be a very powerful motivator to just let people die rather than use an unapproved device. To be clear, I'm personally perfectly OK with using the best available solution - it beats doing nothing. Then there's reality.
Again: when it comes to the situation that so many ventilators are needed, there is no room for diy equipment.
I honestly cannot see why there is resistance to using a DIY machine (when it is the only option). Again, this DIY machine is not something that Homer Simpson would make. It is a machine built to meet the requirements laid out by the MIT team - which are the minimum features and capabilities required for FDA approval.
Obviously no one would choose a DIY machine over an approved one. Why would you refuse a functional DIY machine when the only alternative is no treatment?
Much like someone being rescued from a cliffside isn't going to refuse assistance if the offered harness doesn't have a test tag in date. An uncertain harness is better than a guaranteed plunge into the abyss.
Given the worldwide view that this is a war on the virus, many usual rules and regulations may be temporarily suspended.
All of that is moot if every person who looks at the problem is then convinced to not bother, purely on the basis of being unlikely to be FDA approved.
If nothing else, having more people looking into ways to solve the problem might lead to unanticipated side benefits.
In short, if all this is costing people is their spare time, what is the harm?
THis is the kind of things that can be done when people think out of the box. This university is about 29.5 Km from me (for my US friends that's :18.33 Miles LOL)
Dalhousie professors print a way to keep health-care workers safe
Give a group of engineers some 3D printers and a Staples gift card, and it’s amazing what they can come up with.
An “engineering task force” at Dalhousie University, working with the Nova Scotia Health Authority, took seriously a call from the federal government to use their expertise to take on COVID-19.
What they came up with, using 3D printing technology, is a way to reduce the shortage of face shields needed by health care workers.
“Originally we were talking about ventilators, but ventilators are really complicated, really delicate things,” said Clifton Johnston, who is leading the Dal team and is an associate professor of mechanical engineering.
Johnston and several of his colleagues took 3D printers home with them. He said his is the size of “two microwave ovens stacked on top of each other.”
“When there was the idea that we might be able to help by 3D printing, we were looking at how to manage it, given that Dal was working at a distance and they didn’t want people in labs,” Johnston said. “A lot of other people, like NSCC and NSCAD and companies have gotten in touch and said, 'Hey, we’ve got 3D printers and we’re happy to help, let us know what we can do.'”
“The ones I have at home are about $1,300 and they’re quite good quality. We have other ones that are worth $50,000 and we have ones that are worth $5,000. We’re not taking those home.”
Johnston was sent an article about a university in Hong Kong working to make face shields, and he shared that idea with his group of eight to ten people.
“The face shield has three parts, the clear shield cover which is not printable, the headband the clear plastic shield attaches to, and there’s an elastic that holds the headband onto your head. We 3D print the headband part, which takes about an hour and a half to print,” he said. “The 3D printers we have use a roll of plastic filament. Imagine a spool of 1.75-millimetre plastic thread. You feed it into this machine that has a brass nozzle that gets heated up…so basically it keeps pulling more plastic in, melts it in the nozzle and pushes it out on to this controlled platform that moves.”
The plastic filament costs just $20 a kilo, and Johnston’s team has the capacity to make about a thousand headbands a week.
Unfortunately, that’s not enough, so work has shifted to making the headbands by the use of injection moulding, a faster process. Johnston has found a company that says, given a design, they could produce ten thousand headbands a week.
No matter how the headbands are made, they’re no good to doctors, nurses or respiratory therapists without the actual face shield.
This is where Johnston’s team showed why only smart folks get engineering degrees.
“You know what works pretty good for this? Clear plastic report covers, like the ones that go on your spiral bound report,” he said. “You can get them at Staples, they’re quite cheap and they could just buy them and ship directly to NSHA in large quantities. Then the headband would be designed to match up with a standard three-hole punch and punch three holes in that plastic piece, which would then fit onto little pins on the front of the face shield.”
Team member Craig Arthur said several people were working on the headband design simultaneously, though never in the same room at the same time.
“It definitely has been a steep learning curve for everyone to incorporate technology fully. The biggest difference for us is you can’t get the key designers in one room around one table, picking up prototype and talking about it,” said Arthur, also part of the Dal faculty of engineering. “People would say ‘Hey, I found this feature from this design,’ and when we found something we really liked, that got incorporated into the prototype that we were working on.”
While his colleagues are working from home, engineering professor Jeremy Brown still goes to work every day in Dalhousie’s fabrication lab, having received special permission to do so.
“If you’re working on COVID-19 research you can get permission to come in and use your lab under certain circumstances,” said Brown, who didn’t know about the (personal protective equipment) shortages until he was asked to work on the task force.
“I immediately started Googling what other people were doing around the world, and sent a link to one of my graduate students, and he just started remotely printing one of these prototypes. Within two hours we had a prototype in the room,” Brown said, who is now working on some small tweaks to the headband design before manufacturing by injection moulding begins.
He described the process of virtual meetings as “surprisingly seamless.”
“Makes me wonder why we ever had in-person meetings.”
The science schools here have rooms of 3D printers, 1 per student, and the students are now on holidays, so yesterday I asked about the possibility of using them for the covid19 effort. It comes down to having someone to collect the prints as they finish. There are quite a few of these schools dotted around
Here in AU we've been experimenting with variants of the lasercut headband that Trotec released. The cut time in 6mm acrylic is currently 4 minutes, with nice shiny mirror edges, but this could be sped up. Even at 4 minutes this is over 2000 a week, from a single 80w laser cutting machine. The edge of the acrylic can optionally be lined with a pvc or rubber pinch strip
I'm looking at EVA foam variant what would just work with the standard office supplies clear plastics. A4 seems slighty too small, US Letter might be slightly better, but it seems a larger size visor would be better again. Deepnest.io to see how many brims can squeeze into a single EVA foam tile (the common ones here from Bunnings etc have 450x450 unspoilt area)
I'm seeing whether we can nest the brims and match inner and outer curves. We really need M C Escher.
Our N95 replacement mask is compatible with 3M P100 filters. The filters are approved by the National Institute for Occupational Safety and Health and have an emergency use authorization from the United States Food and Drug Administration.
We are technicans. If you have a hammer, every solution to a problem is a nail. But realize: if you have a oral herpes this virus can be sleeping or activated e.g. by stress. There is no medication available aside from removing newly produced viruses. Why the virus is limited to the lip and stays in place? It is a fact, event if I do not understand why it works this way. Now there is a new virus. He settles in the lung. Evolution will take care of the human species. But for us as individuals this is not the solution. Social distancing is what we can do, professionals are working world wide around the clock and someone will hopefully find the Holy Grail.
But even now we do NOT think out of the box. Because then we would recognize the mechanism behind this outbreak: we are overstressing the ecosystem and that is not what can go on. The pioneers went west, but when they reached the Pacific they should have realized that going west no longer is a solution. Higher clock rates made faster computers, but some moment parallelization was the next solution... Chip thinks out of the box. And in some aspect we do also. There is hope! If only there were no press briefings !
I don't want to be 'that guy', however this is a rather loopy idea.
Making medical devices are a pretty esoteric niche, and everything in there is usually qualified up the ying-yang, and for good reason.
Make a life-supporting medical device out of a non-production, non-qualified device over some qualified ARM/MIPs/X86 thats had years of errata?
I doubt Parallax could even buy insurance for something like that, and even under somewhat relaxed regulations I think this would take a year or two of high-cost validation and qualification.
For a proof of concept, sure.
If you're somewhere where this are none, but you can somehow get a P2 and the parts to DIY, then sure.
However no matter where you are, there a lawyers about....
And this would be a spectacularly bad way to try to get the Prop some 'Press', as it would come off as just that.
Comments
If there are not enough approved ventilators for everyone that needs them what will happen when a hobbyist tries to present their DIY ones to a hospital? The hospitals/patients need to have the authority to make the decision on wether or not to risk using a non-approved device. As long as the device has a reasonable chance to increase survival rate and a low chance at reducing it, then logically they should be allowed to be used when all other options have been exhausted.
I think it is a very plausible scenario where family members will be outraged over a hospital's refusal to allow DIY respirators to be used.
Hope to god not when it comes to medical devices. As the parent of a special needs kid, you would not believe the amount of shyster devices and systems that are out there. A few gears ago, there was a device for autism treatment of no value, no clearance as a medical device, and I would bet some were sold before the FDA raided them. I called it the Lean Mean Shocking Machine. Can you imagine what is already being seen now? Check out the class I recalls. These are almost all from reputable firms. Consider the. consequences of a less regulated system......... Bad food may burt you and maybe a few others, but a medical drug or device failure can harm a lot more.
We see now what happens in a highly optimized world where all resources are used to the maximal level and where is no headroom for self healing processes. We had such situations all the time and there always were stand by systems that could fill a gap. This is no longer the case. So we have to realize: there is no Plan(et) B. But I fear, if the prize for my soul is 1200$ cash and 3500$ for a more save car, there is no place for hope. Science is hard work. https://who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf Like this. Imagine the fight for the P2. Next generation will just see a unique system but not the blood, sweat and tears behind it.
So let's just hope! And be careful and responsible.
That is quite a bit different. Ventilators are proven devices. They actually work. I think that hospitals should be able to make the decision on wether or not to use a DIY ventilator - obviously they would turn away devices that did not meet certain criteria...
If you found yourself in a situation where there were no more commercially made ventilators and a loved one of yours was denied treatment, would you then be okay with not being permitted to make use of a working DIY ventilator? Imagine that a skilled individual had made one (it worked) and was offering it to be used.
Stay all save, and hope for a person to create a vaccine, no matter where and how great his or her country may be.
I only get 388,000 result for the exact same Google search...
I cannot tell if you are in favor of, or against the DIY ventilators.
There are "open source" ventilators such as the Medtronic one where they have made available all the documentation for a well equipped factory to reproduce their FDA approved ventilators - with a very restrictive license. Not a DIY respirator for sure. If factories can get spooled up in time to churn them out then that is a very good thing. Probably, a factory would have to use exactly the same parts as called out in the designs in order to be able to have it certified for use. I think it very unlikely that sourcing large quantitates of very specific components is something that could happen it a short time frame. Substitutions would greatly increase the work/time required to get it FDA approved.
Then there are the open source ventilators such as the one being developed at MIT which are simple (but functional) devices intended to be easily manufactured by any skilled person. I think I have everything required to make at least a couple of the MIT ventilators - I would need to adjust the power transmission portion to match what I have on hand but that is within my capabilities. I'll bet a lot of 'makers" such as myself would be able to make them. It would be a very sad situation if we had the ability to construct devices that would save lives but were prevented from doing so due to regulations. Regulations that should be relaxed during times of crisis.
In the US, there is a... not sure what to call it, but there is a general rule where it is permissible to break the law when doing so preserves life or property. Use of an unapproved medical device when no other is available to help save a life should fall within that rule.
We all are here together because we know, for different reasons, the Propeller is just a superior microcontroller! We are proud to know a person which is humple enough to share his spirit. And I personally grab every Propeller I have the chance to!
And: regulations are a two sided sword: they can protect a monopoly or they can equal chance like on Golfing. It is okay to cut away a hand of you are clamped between stones, but that is not the way it should happen. Lawsuits only create income when there is overflow. But this all seems to be very complex and I should better go back to work ;-)
Please forgive my inability to properly interpret what you have said, are you in favor of skilled individuals constructing MIT respirators or not?
https://www.abc.net.au/news/2020-04-01/supercar-engineers-create-ventilators-to-help-covid-19-crisis/12109718
We're watching the MIT e-vent too. It's very useful information that they are publishing as they work through the problems.
If the time scale is 1 week it will take 25 weeks. So what helps is social distancing, testing and isolation positive people and research. Personal genomics today is state of the art. The technology to produce tests or vaccine in masses should be available, we have to search for a blueprint. If the death toll is in the low percentage and only every second patient can survice ventilation, this indicated having ventilator or not doesn't make a large difference. If we want to do something for those in danger, we have to follow the advice of the scientists. The economy will recover, no doubt. This is not a war with all the destruction. This to me is just a warning.
Medtronic released the specs of one of their older ventilators recently so others could use it to create their own!
https://www.medtronic.com/us-en/e/open-files.html
Yes, my example may be different, but it illustrates one of the most important reasons for the FDA's involvement in medical device manufacture. No device intended for medical use is a proven device until approval. And that is not always a guarantee. Problems could still show up after release. Severity of a recall is indicated by the class of the recall. Class I recall is really not an optimal situation. You could design the most capable, safe, etc ventilator in the world, but unless it has been tested and approved, it is just another device. At least in many of the more advanced countries in the world. That is the only real defense (and at times questionable) against the charlatans and snake oil sellers. And those who mean well but do not know enough to know that they in no way know enough.
Unless Medtronic supplied every assembly and part, the company cloning the Medtronic ventilator could not prove it was identical in every way to the FDA cleared device itself. Also given the age of the released materials, did Medtronic also release any FCOs with the plans? If there were any FCOs how critical were they? There is usually a good reason to go through the process of modifying an approved and released design. Corrective action post recall?
As to your last example, I pray it's a choice that will never happen. How does one define working? It blows and sucks air, but will it cause permanent damage to the lungs resulting in a crappy quality of life if it does not kill the patient outright. I also believe that we will run out of the trained personnel to apply these devices long before we run out of ventilators as the supply of machines increases. Takes time to train up a Respiratory Therapist, seems a 2 year degree with clinical experience is the minimum to sit for certification. Even more in some states and for advanced certifications. So, who is offering open source training on that one?
We (the world) got caught out. How far back do we go? "The Stand", "Andromeda Strain" or any number of low budget doomsday movies and novels, and no one believed it can happen for real (maybe some preppers?). We set up the various levels of agencies to prepare, blew lots of money on "studies" about how this sort of thing may happen but did nothing with the information and ended up in the spot we are in now. So in reality, the governments at all levels should have been better prepared than they were.
So much to rant, so little time and space. My job is to keep medical imaging systems running, so in that small way, I continue to contribute whatever I can to support the ones who depend on these things.........
And, as running idle, switch on the NI-system and think about why something like this can happen. Singular systems, when failing, are fatal. The wind alway blows somewhere. The more energy is collected in distributes places the more stable the system is. Necessary grid connections are expensive, give you as a side effect more stability, reduce transportation losses, ... Being a child I wanted not to be a pilot or firefigher, I wanted to make nuclear power plants to create energy at no cost in any amount. Grown up I realized that energy is available in any amount at very low cost and nuclear power has proven to destroy everthing that was build up by generations, while some say we have to run those facilities just to keep our standard of living, knowing very well, that this can not be rolled out to the rest of mankind.
What is the reason, that when I work with other nations, politics is off limits? What do we have to hide?
I would define "working" as meeting the specs defined by the MIT project.
The discussion on wether or not DIY respirators should be allowed is only relevant if that choice becomes a reality. For purposes of this discussion let us assume two things;
1. There are not enough approved ventilators to treat everyone that needs them.
2. There are DIY respirators that meet the MIT specs that are available, but they are not approved.
Hoping and praying that the described situation never occurs is irrelevant with respects to this discussion.
The point about not enough trained therapists to operate the respirators also applies to the approved respirators. It is the same problem regardless of the approved/not approved status of the machines.
The point about an inferior respirator saving a life, but that life having a poor quality... well that is a decision for doctors, patients and families to make. The availability of an DIY respirator does not make that a necessary outcome. From what I understand about the healthcare field, the priority is to preserve life.
Again: when it comes to the situation that so many ventilators are needed, there is no room for diy equipment.
I honestly cannot see why there is resistance to using a DIY machine (when it is the only option). Again, this DIY machine is not something that Homer Simpson would make. It is a machine built to meet the requirements laid out by the MIT team - which are the minimum features and capabilities required for FDA approval.
Obviously no one would choose a DIY machine over an approved one. Why would you refuse a functional DIY machine when the only alternative is no treatment?
Much like someone being rescued from a cliffside isn't going to refuse assistance if the offered harness doesn't have a test tag in date. An uncertain harness is better than a guaranteed plunge into the abyss.
Given the worldwide view that this is a war on the virus, many usual rules and regulations may be temporarily suspended.
All of that is moot if every person who looks at the problem is then convinced to not bother, purely on the basis of being unlikely to be FDA approved.
If nothing else, having more people looking into ways to solve the problem might lead to unanticipated side benefits.
In short, if all this is costing people is their spare time, what is the harm?
Dalhousie professors print a way to keep health-care workers safe
https://www.thechronicleherald.ca/news/local/dalhousie-professors-print-a-way-to-keep-health-care-workers-safe-433200/
Give a group of engineers some 3D printers and a Staples gift card, and it’s amazing what they can come up with.
An “engineering task force” at Dalhousie University, working with the Nova Scotia Health Authority, took seriously a call from the federal government to use their expertise to take on COVID-19.
What they came up with, using 3D printing technology, is a way to reduce the shortage of face shields needed by health care workers.
“Originally we were talking about ventilators, but ventilators are really complicated, really delicate things,” said Clifton Johnston, who is leading the Dal team and is an associate professor of mechanical engineering.
Johnston and several of his colleagues took 3D printers home with them. He said his is the size of “two microwave ovens stacked on top of each other.”
“When there was the idea that we might be able to help by 3D printing, we were looking at how to manage it, given that Dal was working at a distance and they didn’t want people in labs,” Johnston said. “A lot of other people, like NSCC and NSCAD and companies have gotten in touch and said, 'Hey, we’ve got 3D printers and we’re happy to help, let us know what we can do.'”
“The ones I have at home are about $1,300 and they’re quite good quality. We have other ones that are worth $50,000 and we have ones that are worth $5,000. We’re not taking those home.”
Johnston was sent an article about a university in Hong Kong working to make face shields, and he shared that idea with his group of eight to ten people.
“The face shield has three parts, the clear shield cover which is not printable, the headband the clear plastic shield attaches to, and there’s an elastic that holds the headband onto your head. We 3D print the headband part, which takes about an hour and a half to print,” he said. “The 3D printers we have use a roll of plastic filament. Imagine a spool of 1.75-millimetre plastic thread. You feed it into this machine that has a brass nozzle that gets heated up…so basically it keeps pulling more plastic in, melts it in the nozzle and pushes it out on to this controlled platform that moves.”
The plastic filament costs just $20 a kilo, and Johnston’s team has the capacity to make about a thousand headbands a week.
Unfortunately, that’s not enough, so work has shifted to making the headbands by the use of injection moulding, a faster process. Johnston has found a company that says, given a design, they could produce ten thousand headbands a week.
No matter how the headbands are made, they’re no good to doctors, nurses or respiratory therapists without the actual face shield.
This is where Johnston’s team showed why only smart folks get engineering degrees.
“You know what works pretty good for this? Clear plastic report covers, like the ones that go on your spiral bound report,” he said. “You can get them at Staples, they’re quite cheap and they could just buy them and ship directly to NSHA in large quantities. Then the headband would be designed to match up with a standard three-hole punch and punch three holes in that plastic piece, which would then fit onto little pins on the front of the face shield.”
Team member Craig Arthur said several people were working on the headband design simultaneously, though never in the same room at the same time.
“It definitely has been a steep learning curve for everyone to incorporate technology fully. The biggest difference for us is you can’t get the key designers in one room around one table, picking up prototype and talking about it,” said Arthur, also part of the Dal faculty of engineering. “People would say ‘Hey, I found this feature from this design,’ and when we found something we really liked, that got incorporated into the prototype that we were working on.”
While his colleagues are working from home, engineering professor Jeremy Brown still goes to work every day in Dalhousie’s fabrication lab, having received special permission to do so.
“If you’re working on COVID-19 research you can get permission to come in and use your lab under certain circumstances,” said Brown, who didn’t know about the (personal protective equipment) shortages until he was asked to work on the task force.
“I immediately started Googling what other people were doing around the world, and sent a link to one of my graduate students, and he just started remotely printing one of these prototypes. Within two hours we had a prototype in the room,” Brown said, who is now working on some small tweaks to the headband design before manufacturing by injection moulding begins.
He described the process of virtual meetings as “surprisingly seamless.”
“Makes me wonder why we ever had in-person meetings.”
Here in AU we've been experimenting with variants of the lasercut headband that Trotec released. The cut time in 6mm acrylic is currently 4 minutes, with nice shiny mirror edges, but this could be sped up. Even at 4 minutes this is over 2000 a week, from a single 80w laser cutting machine. The edge of the acrylic can optionally be lined with a pvc or rubber pinch strip
I'm looking at EVA foam variant what would just work with the standard office supplies clear plastics. A4 seems slighty too small, US Letter might be slightly better, but it seems a larger size visor would be better again. Deepnest.io to see how many brims can squeeze into a single EVA foam tile (the common ones here from Bunnings etc have 450x450 unspoilt area)
I'm seeing whether we can nest the brims and match inner and outer curves. We really need M C Escher.
https://barrowneuro.org/get-to-know-barrow/barrow-innovation-center-2/3d-printed-n95-mask/
And there you have it:
emphasis added
But even now we do NOT think out of the box. Because then we would recognize the mechanism behind this outbreak: we are overstressing the ecosystem and that is not what can go on. The pioneers went west, but when they reached the Pacific they should have realized that going west no longer is a solution. Higher clock rates made faster computers, but some moment parallelization was the next solution... Chip thinks out of the box. And in some aspect we do also. There is hope! If only there were no press briefings !
Making medical devices are a pretty esoteric niche, and everything in there is usually qualified up the ying-yang, and for good reason.
Make a life-supporting medical device out of a non-production, non-qualified device over some qualified ARM/MIPs/X86 thats had years of errata?
I doubt Parallax could even buy insurance for something like that, and even under somewhat relaxed regulations I think this would take a year or two of high-cost validation and qualification.
For a proof of concept, sure.
If you're somewhere where this are none, but you can somehow get a P2 and the parts to DIY, then sure.
However no matter where you are, there a lawyers about....
And this would be a spectacularly bad way to try to get the Prop some 'Press', as it would come off as just that.
+1 for the idea though.