While I am not familiar with the standards used in the UK, the Australian standards are, I believe, quite similar (AS 3551:2012). 3551 mandates that all devices must be tested at a minimum of 12 monthly unless a risk assessment shows that less frequently is acceptable. Do the UK standards mirror this approach?

If so, Kevin, have you done a full risk assessment on the devices you are now excluding from annual testing and if you have I would love to have a look at them?

I would agree that a lot of the testing that we do is a complete waste of time and resource and I wish we did not have to do it but this is what the standards require and until the standards change or we can produce a risk assessment that is robust enough to stand up in a court of law we are stuck with it. To ignore the standards without this is to expose both yourself and your employer to a legal risk that, if revealed, could expose you to disciplinary action, dismissal for gross negligence, or land you in court.

And by the way, I did not say that a thermometer was a "high risk" device, clearly it is not, but it is a diagnostic device and therefore falls under the standards.

Dave


Thoughts and information provided on this forum are mine and mine alone and do not necessarily reflect the policy of NSW Health. They may also be complete bollocks!!