Help advice needed please, testing medical devices

[zacazoom]

Hi

I’m hoping someone could point me into the right direction. Thank you in advance for my many questions.

To give you my background I currently work as an IT consultant / trainer and look after approximately 70 GP practices.
I am freelance and have been asked on a few occasions about PAT testing their items.

I did a Pat Testing course about nine years ago and had a few contracts but stopped them after my IT side of the business started to take off. I am 2391 qualified but not been testing for a long while.

What’s involved in testing medical devices? I believe you do the normal pat tests but also have to do patient leakage and patient auxiliary.

What would be the going rate for this? Is it the same as just pat testing ordinary items which wasn’t a lot from memory. I remember a while back I used to charge £40 for the first ten items and then something like £1.00 per every other item after that.

Would you charge more for these additional tests?

Then I believe you test items to make sure they fall with in certain tolerances, spirometers, ecgs, defibrillators etc.

Why do people put a calibration sticker on an item if it hasn’t been calibrated and just tested with in tolerances. Is this correct?

I take it if it doesn’t fall with in the correct tolerance then you would have to send it off to the manufacturer to get it calibrated.

So I take it you change separate for these tests on top of the pat testing cost.

Does anyone suggest a good place to research this. Where I can buy the test equipment, sims etc from maybe secondhand etc because I believe they are really pricey.

Thank you again.

 

[netblindpaul]

It's not that onerous, but, well there are two buts, the testers are an order of magnitude more in cost than a PAT tester, and, remember if you get it wrong, you can easily kill someone, and then there are two standards you would need to get, I think they come to between £400 & £500 IIRC for the two, then you need to know the details on the equipment you are testing.
That would mean manufacturers data, which they may be reluctant to give you without the surgery intervening, and, you would need to be familiar with the product standards they are between £300 & £400 each again IIRC.
The charges would be considerably more than PA testing, but, you would need not just the medical equipment tester, you would need the patient simulators too.
I have been down the route with a local health trust looking at us doing the electrical testing on some equipment they have in patient homes, and it is quite a bit more.
When I looked into this about 5 years ago at the request of the trust it was going to cost about £3k to set up with the tester & info on top of that.

 

[zacazoom]

Thank you very much. Appreciated.