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During the COVID-19 pandemic, ventilators are in short supply. As an engineer, I am interested in learning the risks/challenges of designing an OpenSource ventilator. And how it could be tested for proper functionality.

Medical equipment has to rise to the highest standards, especially when it is required to work flawlessly in an emergency situation.

Are there existing OpenSource ventilators projects? What requirements would a OpenSource ventilator have to fullfil?

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In the United States, any ventilator must fulfill:

  1. Safety and
  2. Efficacy

requirements as set forth in Medical Device Standards.

Sales of medical devices are regulated by the FDA: a lengthy (data intensive) and paperwork intensive process. FDA ventilator specific guidance within the context of COVID respirator demand

I would suggest that you identify testable system requirements. The quickest way to learn is to operate an existing device: if you have access to a healthcare professional (Anesthesiologist or Respiratory Therapist), he / she would be the best functional resource. A good starting point (do your homework before talking to anyone) is this functional explanation on youTube.

Challenges for hacking a ventilator for the COVID crisis comprises:

  1. A design where parts (Bill of Materials) are readily available (100K to 1M devices needed)
  2. A testbed to demonstrate Safety and Efficacy testing + any required regulatory approval
  3. Skilled labor to manufacture assemble and test

UPDATE

April 8 2020: Medtronic is sharing its portable ventilator design specifications and code for free to all That being said, a 510K and all the document would be required by the FDA ensure requirements discussed above are met.

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    I started to write an answer referring to the FDA and so forth, but then I thought about the developing world where there are no such regulatory agencies and where an unregulated device that basically "just works" and that they can afford might be welcome. Taking those countries into account would greatly improve your answer.
    – Carey Gregory ♦
    Mar 24, 2020 at 4:14
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    @CareyGregory Efficacy (basically just 'works') does not confer safety. Because of my experience with medical device development, I would argue safety is just as important as efficacy, if not more.
    – gatorback
    Mar 24, 2020 at 4:57
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    Sure, I get it, but imagine you're a doctor in Sudan and you've been offered a ventilator that might malfunction and kill half your patients. The alternative is 90% of those who need it will die due to lack of that ventilator. What do you do?
    – Carey Gregory ♦
    Mar 24, 2020 at 5:20
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    Doctors use what they have. They would not choose losing 90% of their patients over 50%.
    – Carey Gregory ♦
    Apr 8, 2020 at 16:19
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    @gatorback Good luck manually ventilating patients who outnumber your staff and need ventilation for days or weeks.
    – Bryan Krause ♦
    Apr 8, 2020 at 17:04
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This is not my work, but there is now a Youtube video that goes into the complex details of actual medical ventilators, and what needs to be done for a DIY device to do it safely.

A Guide To Designing Low-Cost Ventilators for COVID-19

By Real Engineering, published April 4, 2020

https://www.youtube.com/watch?v=7vLPefHYWpY

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    Can you add a brief summary of the video's main points? Maybe just a bullet list. Otherwise your answer is a link-only answer that's in danger of becoming useless in the future if the video is ever removed, which happens a lot on youtube.
    – Carey Gregory ♦
    Apr 8, 2020 at 14:14

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