There is a reasonable chance that this will not be as useful as the team hopes:
1) They are increasing maximum pressure and pressure rate changes beyond the built-in design parameters. If these new parameters are outside what the engineering requirements document spec, these changes are a problem in seeking EUA.
2) In regulatory affairs, authorized, cleared, and approved have very specific (and enforceable) meanings. If someone is loose with how they use these words, it suggests they don’t have someone with regulatory experience involved (a negative sign). The earlier the team can engage with someone with regulatory experience, the better.
The problem is that high pressures can cause barotrauma. So you might end up increasing PEEP beyond what a patient's lungs can survive, and because you're using a CPAP machine instead of a ventilator there's not really any facilities to measure pressures that high. Or there are but they were never characterized because the machine doesn't measure pressures that high. And because they were never characterized you may not actually be delivering the pressure that the machine says you're delivering. So this is pretty crazy.
The other thing ventilators typically include is pressure alarms and high pressure limits. Under routine use the high pressure limits keep you from popping patient lungs in volume-controlled modes. A pressure-controlled mode like BiPAP may be okay in this case since it provides those limits. The downside of pressure-control is that the patient's lung compliance and alveolar recruitment may change, so you can start off delivering a certain tidal volume at a certain pressure and then because of compliance changes the patient's alveoli lose the ability to contain the same volume of air, so the patient is losing oxygenation unless you change the settings.
My point is that there are a lot of considerations beyond simply delivering a fixed pressure of gas into a patient's lungs and hacking a CPAP may not meet those requirements.
The idea is manufacturers don't want to loose money and do this stuff themselves, so somebody donates their time to bring this hack to the FDA, and then the hospitals can use it.
This is possibly the most irresponsible project I've ever seen.
There appears to be a deep lack of regulatory experience, along with a deep lack of QC, and it's presented as a jailbreaking, i.e., what is done to your phone.
Some kinds of regulations are written in blood, or, in this case, bloody sputum.
I mean, there’s still time for George Hotz to enter the ring and win that title.
A lament, I wish it were possible to convince tech people that they are not the only clever people in the world: regulatory bodies and medtech and pharma companies are packed with equally clever people, who are quite capable of moving fast but without breaking things, that have an unmatched advantage in having domain experience (part of which is a healthy respect/fear of the unknown in medicine, like you say, regulations are written in blood). It would be a lot more productive to support those people than to do these hackathon projects.
1) They are increasing maximum pressure and pressure rate changes beyond the built-in design parameters. If these new parameters are outside what the engineering requirements document spec, these changes are a problem in seeking EUA.
2) In regulatory affairs, authorized, cleared, and approved have very specific (and enforceable) meanings. If someone is loose with how they use these words, it suggests they don’t have someone with regulatory experience involved (a negative sign). The earlier the team can engage with someone with regulatory experience, the better.