Issue Clearance for use in hospitals CE marc or similar #8
Hi, we made 150 visors European A4 versions with PLA under clean room conditions and it worked very good !
Our congratulations for the straigtforward design ! ! !
But now we face tremendous concern by users.
Do you know if this model is somewhere in Europe approved by any official health agency or got a CE mark ? If yes, could you foreward a specific link ?
Spanish Hospitals and physicians MUST reject now all donations because they are afraid of legal demands ...
Thanks a lot
Thanks Eric for your quick feedback. This was also our impression, but this morning we learned that the clearance by our national medical agency is required, thus hospitals stopped using them. Lets hope that this changes, but there are so many very complex versions with many tiny plastic pieces and of bad (unstable) quality loosing fine ABS fibres ... Not like your design. Congratulations again for the desing and thanks for the link.
If you get a link to a validation by any European halth care agency, please let me know. It might help decisions makers in our local hospitals to take the responsibility.
Best wishes !
CE marking is simply not possible for any kind of distributed printing effort. It requires DoC amongst other things, that cannot be written not knowing the end production facility.
It has been validated for use on numerous hospitals around the world and there is probably a hundred thousand units of this face shield in use today.
Here is one article from the US: https://www.npr.org/2020/03/28/822911643/one-way-to-help-strapped-hospitals-print-ppe-using-3d-printers?t=1585485596389
In Sweden, multiple health care regions accept these and they are in use at multiple swedish hospitals. They are all using it under the rule of "self produced equipment", which means that the hospital or region itself takes on the responsibility as the producer, since it is not possible to get the CE mark that is otherwise needed.