EBME Forums Forums Management Medical Equipment Management Assessing EBME dept competence

It would appear that this discussion has two key questions:

1. What evidence do we keep for ensuring that our staff are competent?
For me registered staff should be on the VRCT (IPEM)and have records of training esternal and internal. Records of teaching back to a more experienced engineer how the equipment is serviced is a very good method.

2. CQC/NHSLA compliance
I too had a CQC interview recently. I started by asking them for a definition of safety. In the end they agreed that the IEC Guide 51 definition I gave them was right. Safety is 'freedom from unacceptable risk'.

All medical engineering teams either in a structured was or simply intuitively manage down risk. We have a structured approach in that equipment models are classified into 5 risk bands based on the 'immediacy of the impact on the patient'.
And we have a system of monitoring how well we are doing.
That's our model - it's the best we've come up with so far, but it's not the only model. there are things where we declare that we don't routinely service, but have a rationale why we don't.

The impression I get is that the CQC want to hear that medical engineering teams understand the challenges and risks, have a structure/model that addresses these to the best of our ability and resources.

Good records and a monitoring system are these days essential.

And is there a mechanism for passing up difficult problems (e.g. major risks) up the ladder, rather than hiding them within the local medical engineering team.

"Immediacy" only?

Not "consequence"?

Care to list your five levels of Risk, there, Chris?

Chris

You are right on the record keeping especially if there is a chance of standing in front of the judge.

We have the problem here that a ward says There was a problem with a piece of equipment while it was on a patient. They raise an incident report and send it off to risk. Now they get around to telling us we test it and find it good/bad but there is no link to the incident. The powers that be have been told and have done sod all about it.

As for the training records we maintain them as education was tasked and has so far lost everyones record in the trust. Lucky for our backups. (certs in a folder). They are now asking everyone if they have done their health and safety, so far it looks like everyones up to date

I dont agree with the VRCT in that the name gives it away (Voluntary). How are you going to defend yourself in court if you dont employ someone not in the voluntary register. If your driving licence was voluntary would you pay for one?

Keep your records up to date as there is no support when the proverbial hits the fan. That includes all the emails highlighting the problem.

Sounds like you're besieged by incompetence there, Billy.

But, don't worry Mate ... "lessons are being learned" the whole time.

Yes but they are only learnt when it hits the fan. They are talking about using bore hole water here now even though the renal national guidelines say this is a no no. Why does it have to end up in court with someone dead before they get there act together. It is all down to cost by the way.

If we had less management we may have the money to pay for people who can do the job and for the equipment needed.

I used to work for a company installing bore holeds and water systems. One client a farmer was told that he could not use the water from the mains for food production as it did not meet the standards, but the water he got from his own well / bore hole did pass the standards. He was unable to get recompense from the water company as they said that it was fit for human consumption. Enough said!

It could be something to do with the big radioactive place down the road here

Getting back to Russ.

If you are going to use an outside agency for the calibration/service of your equipment then things to check.

1. A list of the test equipment used on the returned item (for audit purposes).
2. Sevice engineer (print and signature) again for when it all goes wrong (Are they in possession of certification from the manufacturer or are they covered under the companies insurance)
3. Is the company you are using insured to carry out the task.
4. Do you operate a full trust procedure or do you carry out a batch test of equipment returned.
5. Full data access to the tests carried out (Flow/occlusion graphs with time/date of test).
6. If a repair has been carried out, have they used oem parts or third party. Also whats the warranty on the repair.

Its a minefield, good luck.

All good stuff, Billy.

But I think you may find that Russ could be thinking in terms of an NHS EBME department at a nearby hospital.

Remember also that you get what you pay for. So all that stuff you mention should be listed up front in the original contract tender, and not sprung on the "contractor" later on.

No-one likes surprises (well, not in this context, anyway). And neither do clients usually enjoy receiving change orders, either!

Meanwhile, in situations like this, I would advise that it may be better to bring in temporary staff to carry out the work you need doing. That way, you remain in control.

Interesting topic...

Russ, ask the provider for their own PCA form for outcome 11 and use this as evidence and use this for your own evidence of 'external assurance'. If they are ISO then you could also seek a copy of their certificate or audit report as further verified checks of their competence.

After all, both CQC and ISO will be monitoring competence under various clauses and this will be a good source of evidence with very little work for you to do.