[koolk3ychain]

A good friend of mine had the experience of nearly dying after a mobile ventilator in an ambulance failed after he was involved in a serious car accident. It was later found that the ambulance operator was using devices that hadn't been cleared by the FDA yet. Although they came from a Turkish "medical device" company, they were not cleared for use in the US and left my friend with brain damage and PTSD.

I don't care that the hardware involved in your project was "made be a medical company", it's not hardened tech. Also, rust is by no means hardened - look into "provably complete" languages if you want to see what a true "hardened" lang is. There's a reason why medical devices and serious "hardened" tech (military or otherwise) is validated and cost tens if not hundreds of thousands of dollars. It's because teams of engineers spent weeks or years coming up with every possible problem or failure pattern.

To be frank, I'd rather pay a nurse $50k in cash to pump a vent bag next to me than rely on your "project".

[pp-ir]

Sorry for your friend.

Problem with vent bag is that you cannot maintain a positive expiratory pressure (around 10mmHg of pressure during the expiration to prevent lung to collapse alveoli). For Covid-19, all the projects based on mechanized vent bag where useless because of the type of disease.

There are several companies behind the project. The company who makes the electronics is Tronico (https://www.tronico-alcen.com/en/markets/medical). It has all the medical certifications needed.

We are currently going on with ANSM certification (equivalent of US FDA). It is a long 2 years way, with lots of papers and tests... If it is approved, sure it can save life everywhere in the world. If it is not, it was a project where we learned a lot.

By the way, ambulance ventilators are harder to develop and to approve. Hardware must resist huge shocks and accelerations.

As said previously, the Rpi part and the software is not critical at all, it is here to fill a gap between the minimal UX and the expected UX. See https://news.ycombinator.com/item?id=25671617 and https://news.ycombinator.com/item?id=25671318.

[ska]

> If it is approved, sure it can save life everywhere in the world.

It's worth noting that mostly regulatory approval is jurisdiction specific, so the device will need to be separately approved by a bunch of different bodies. ANSM is the french local body, but it is EU MDR you probably have to meet; this at least gets you the EU countries but for example will allow your device to be used in the USA, you would still need FDA there. Some jurisdictions, particularly smaller ones, will rubber stamp things if you have the right approvals but it's still finicky and of course with a physical device you have to deal with things like different power standards.

The approaches are similar but annoyingly different enough that this isn't easy. Luckily they are both reliant on ISO13485 at core, so there is overlap. It's not just paperwork either, you can definitely design something that will not pass in another jurisdiction if you aren't careful (e.g. due to materials used). Further, you need separate certification to a standard as both a manufacturer and developer, and these don't carry over automatically either.

People are working on making this easier to do worldwide, but it still isn't easy. For example you can use MDSAP to get a regulatory audit that meets multiple countries requirements at once.

[intricatedetail]

How big portion of these approvals is to have right people to get paid and to actually make sure the product is safe? We're the any "blunders" like with Boeing?

[ska]

Fwiw in my experience, a huge portion. Not that the system is perfect, but it’s trying to do the right things.

[jeroenhd]

I agree that this project can be incredibly dangerous if people try to sell them in countries with well-developed, well-tested systems of healthcare.

However, billions of people don't have the luxury of tested and verified medical devices. The price of a single machine might be close to the monthly budget of the entire hospital. In those cases, any small hacks are welcome if they can help save a patient's life. A crappy, half-decent ventilator is way better than no ventilator at all. Until rich countries start buying hospital devices for poor countries en masse, providing cheap alternatives to proper medical devices can save lives.

The company behind this seems to be French and if it ever gets used in France without certification then they've probably got a huge lawsuit and potential criminal liability on their hands.

According to the project's website, they are trying to comply with European medical regulation (if Google translate got that right) and their Github mentions they're working with regulators. This isn't a hobby project by a bunch of bored students, the project seems to be a proper attempt at making capable medical devices that can be extended upon without IP problems.

[mbreese]

While I don't disagree with your overall sentiment (I can't imagine relying on a RPi powered device -- even if it is just a display -- for clinical use), I think you're overthinking the motivation here...

> To be frank, I'd rather pay a nurse $50k in cash to pump a vent bag next to me than rely on your "project".

From what I've read (admittedly not much) -- this project isn't trying to disrupt the ventilator industry or make a bunch of sales. It isn't designed to give you a choice of a ventilator to remove a nurse. It's for situations when you don't have another choice... for when a hospital has run out of proper ventilators or there isn't a nurse available. This is not a first-choice device (even if it could be adapted to that in the future).

[kbelder]

To be frank, more people would be saved with fallible yet cheap medical hardware than 'proven correct' hardware that costs $100,000 plus.