EBME Forums Forums Management Medical Equipment Management Safety Test Results: To keep or not to keep?

I would like to know what other departments do about the recording (or not) of electrical safety test results. We have been recording results for years but are now re-considering. We may just record the initial acceptance values and then record a "Pass" for future tests.
I know all the arguments for trending results etc., but has that proved useful in recent years to anyone?

We have always recorded results of all tests, first manually, now electronically.
This enable both monitoring of changes within item under test and the test instrument itself.
This validates both instruments and working practice, who knows when these may be questioned.

Hi Paul.
Yes, recording actual test results has proved useful. We found a mains transformer which was gradually getting leaky, had a replacement made (which took weeks !) and replaced it before it had a chance to cause any problems.
We are just on the point of getting the COBAC computer system up and running, so we will be recording everything on there - but will probably still keep the written / printed test results as a backup / reference.
You're right - you never know when someone might ask for them - like the Coroner !

Paul

We do as you have said. That is, we record the initial electrical safety test results and compare these with any others that we carry out during the life of the medical device.

Therefore, we tick off on the recording system that a electrical test has been carried out and that the device passes. You can still see any variations between the initial results and the latest, eg ripple heat unit, immersed water heaing elements, (insulation breaking down).

Of course it is your risk assessment that matters, my assessment is that I do not need to see a plethora of useless figures, thus creating a lot of wasted time.

Thanks for your answers! I have also spoken to Adrian Mann at the MDA about this and asked for his opinion.
He said that recording the initial values, recording future tests as a Pass/Fail only and investigating any appreciable change seems a good compromise.

Hi Paul.
Just a simple question. If you are only recording the fact that the equipment has passed (the only figures available being from the original acceptance test) how are you going to decide when the changes which are bound to occur with age (that sounds familiar !) have become significant ?
Originally the unit might have passed by a significant margin which has been gradually reducing over the years, but then suddenly there is a step change and the thing only just passes. How would you pick that up if you're not recording results ?
That is exactly what happened with the transformer I mentioned. The equipment certainly wouldn't have been safe within a few months, judging by the rate of change of the readings and would have posed a risk long before its next annual test was due. But it did still pass !

Well, that's a good question Roy! I suppose that if we do what is suggested then a risk assessment will have to take that into account.

If an item of equipment changes constantly then there will be a point when an engineer will think it's on the high side and check the initial results.
Even if that doesn't happen then does it mean that at 501uA it suddenly becomes lethal? It would be picked up within the 12 month period (hopefully!). You could argue that a step change could happen at any time I suppose.
Paul

Surely keeping the life History including it's electrical safety is the only way too go??

In these days of " Liability" and Risk Assessment and then Controls Assurance, the gradual breakdown of insulation and earth leakage should be kept?..on record Always..??

We all know that tests can be falsified?..Wasn't that why the Tester with printer was introduced??..( Hard copy..evidence..?) and an Engineer can pass something which is on the edge of tolerance, but surely the point is to check it again before the next PPM. If one suspects that the electrical safety is failing then surely the item should be withdrawn from service and or repaired??...
I personally would not agree with the old system of "Elec safety OK" being brought back..!!

I do not beleive in recording every single result, electrical or otherwise, after the initial commissioning tests have been done.

If the machine passes the required tests, why write a 'life story' about it.

We as technicians are empowered to do the job so the judgements we make should be qualified ones and respected by our employers.

If a piece of equipment has work done to it then the results should be recorded, at that time. Why burden ourselves with work that may not be necessary.

Sorry, Mark, but I disagree. It's a similar argument to the one about the MOT on cars. Just because it was tested yesterday and passed doesn't (apparently) mean it's still safe today. If you are testing something for safety reasons, then you should take account of the fact that you won't be testing it again for several months. You can't make a judgement about whether or not the device will still be OK till the next time unless you know the history and have some hard evidence to base that judgement on.
That hard evidence is the actual test results.