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OpenVent Bristol create opensource low cost ventilators

Favourite things are Family, Music and Judo. Also, I have the ability to retain and quote useless facts, something that pleases me but can annoy others. My engineering hero - Isambard Kingdom Brunel


June 14, 2021 08:39

So I am curious about a ventilator not authorised, and I think you mean not certified by an appropriate third party body, for medical use? Are you able to explain the point of that approach? Do you feel all medical devices should be sold as unfit for medical use, to reduce the cost? Obviously, the cost of medical devices sky rockets when you have to certify them for medical use. If we are moving to low cost uncertified medical devices, when or how does one know when a device is fit for medical use? Obviously by telling people the device is unfit it seems. Is your position based upon the idea that many devices claiming fitness for medical use are often found not to be, so better be honest up front? If the question is how unfit for medical use a device is, where would this unit fit on a scale of dangerously unfit up to fit? Can you answer that without pulling out a medical device certification standard? Or asking a third party medical certifier?

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June 15, 2021 08:42

@Asterion thank you for your comment. We reached out to Darren and here is his response: "The simple reason that our device is not certified is because we are still developing it, medical certification happens right at the end of development once there are no more changes to make. Medical devices are not be allowed to make it to market without certification by the appropriate body for the country of sale (each country has its own process for this). OpenVent-Bristol will not be applying for medical certification or taking the project to production, instead once our design is ready we will pass it onto one of our manufacturing partners who will be responsible for this. We are beginning to work with to get our design to market in India." If you want to follow up, please feel free to reach out to us or Darren directly. Thank you, Kamilla

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