I haven't got the standards to hand but I am sure that there is a clause in the ISO 15189 and/or 22870 that states if a device or test is an established product with good published evidence of its accuracy, then a smaller verification is acceptable. I left the standards in work but if someone can reference this please do.
It would cut down on a lot of time consuming work in an emergency situation where deployment is rapidly required to support patient management.
Regards
Tony Cambridge
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Theresa Hornsby
Sent: 28 March 2020 09:19
To: [log in to unmask]
Subject: Re: SPARE ABL90 FLEX OR ABL90 FLEX PLUS
Hi Divina,
Like Tony we are looking to purchase handheld devices for use in some areas.
I am sure that we will all be willing to share validation data to assist others - as much as that can be of use to us. I appreciate that we will all have to do our own work too.
Theresa
NNUH
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