non-technical: Petition to EU & health ministries for Emergency Use Authorization

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bdb
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Joined: Thu Apr 02, 2020 10:11 pm
Location: now in Italy -- from San Francisco
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non-technical: Petition to EU & health ministries for Emergency Use Authorization

Post by bdb »

l found Ventilaid via Pubinv.org. l am impressed by how far along it is in development and testing. l wish that it can be implemented in hospital and non-hospital settings right now. To that end, pardon my forwardness, but would you sign this petition to the EU and member state health ministries to expedite new/ open source technology for the current public health emergency?

Petition is hosted here, (a copy was also submitted to the EU Parliament): https://secure.avaaz.org/en/community_p ... h/details/

The EU Parliament has the power to adapt enforcement of CE regulations in the face of this crisis.

l've looked into a couple of European OS ventilator projects, who began to worry about compliance. l contacted the health ministries of Italy, Spain and France to ask if they have a Emergency Use Authorization (FDA policy) equivalent. Italy says they want to expedite but need more information, they have no enforcement policy. France said they will expedite clinical trials. Spain returned a document (https://drive.google.com/file/d/1xtO3Km ... sp=sharing) that listed ISO regulatory demands that seem quite rigid.
But the biggest hurdle is third party testing/ certification bodies are offline in places like Italy and Spain. Such provisions also favor companies with existing connections. This sucks. A design cannot get to the patient if it cannot cut through the red tape.
The EU promulgating a suspension of strictly enforcing CE/ ISO standards will prompt member states to allow emergency use. Please sign the petition. Thank you!

-Bullitt D. Bourbon