Quick tests - bad results in Spain

That's very bad news, hope they find an alternative for you guys over there.

This is why things take so long to get out medically, as not having something is sometimes better having confidence in something that probably doesn't work, it's like going climbing with a defective rope. You only find out when it's too late.
 
Wev1 said:
That's very bad news, hope they find an alternative for you guys over there.

This is why things take so long to get out medically, as not having something is sometimes better having confidence in something that probably doesn't work, it's like going climbing with a defective rope. You only find out when it's too late.
Click to expand...
Yep. Makes you wonder about new manufacturers of ventilators.
 
The EU scheme was to bid on the basis of delivery of the proven ventilators within two weeks of contract signature. A minister this morning pifflewaffleing was indicating weeks to get a prototype (at odds with previous reports), then a need to test it and then manufacture starts - so a month before they even begin to arrive in hospitals. I don't fully understand the mechanism of ventilation of patients, but the government spec for a cheapo ventilator is for emergency use for a few hours, but clearly preferably longer. I hope this 'miscommunication' with the EU doesn't seriously come back to bite us.
 
spanishman said:
Yep. Makes you wonder about new manufacturers of ventilators.
Click to expand...

At least you can see if a ventilator is working, they're a lot more simple and there's already 1000's of designs out there.

I think I would rather have it this way with easy ventilators, than having easy tests, unless we had 60 million tests that all worked instantly. Although both options are crap.
 
Wev1 said:
At least you can see if a ventilator is working, they're a lot more simple and there's already 1000's of designs out there.

I think I would rather have it this way with easy ventilators, than having easy tests, unless we had 60 million tests that all worked instantly. Although both options are crap.
Click to expand...
I agree having low numbers of both is a very bad thing. I guess the worry with something like ventilators is probably their reliability. With the new tests it is a bit different as it is more about accuracy.
 
Following the cosmetic surgery scandal in France a few years ago manufacturers of medical devices were forced to implement quality systems that were as rigorous as pharmaceutical companies. To get a CE mark they have to adhere to ISO 13485 a bit like 9001 but for device companies. Before you get a product you have to have the system in place. The device will have to be produced through an audited and defined process using parts from approved sources. The device has to be tested and performs the way it claims to do.
If the new players don't have those systems this could take ages.
As a non-member of the EU, the government could decide to scrap the red tape and produce non CE marked product for domestic consumption.
Ironically my last project was for an ECMO device that takes the load off infected lungs. I couldn't raise the investment needed to complete its validation......
 
You must log in or register to reply here.
Back
Top