Comment by pp-ir | Hacker News Reader

Comment by pp-ir | Hacker News Reader

Parent Full thread

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.

> 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.

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?

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

Reply on news.ycombinator.com