EBME Forums Forums Management Professional Issues Biomedical accreditation

Fair enough, Denis. But how do you demonstrate (prove is a bit too strong for me) that the manufacturer’s procedures have been followed, then? A printout from HECS (for example), swearing on the Bible, or what?

Come to think of it, Mate, this could be an opening for us – we could set up as “expert witnesses” to say whether the piece of kit in question was serviceable or not!

For the life of me, I can’t see why an official body such as the MHRA does not sort out matters like this. What do we pay our taxes for, anyway?

Its much the same in the middle east, you find yourself "specifying" equipment your sponsor or the consultant wishes to buy, different rules do apply though, Ill never forget the place.
Hareesh, re JCIA/JCAHO accreditation, contact moleary@jcrinc.com , youll get a lot of help there, there is a lot of good info re standards too from mpotter@jcrinc.com

Good idea Geoff, but unfortunately the MHRA are seen as the expert witnesses, god knows why! I have actually sat in on a coroners inquest and it was clear that the chap from the MHRA was anything but expert.

Sadly as far as the courts/coroner is concerned they are the people from the government therefore they must be in the know.

How do we go from here I just don't know.

A few years ago when I was a company man we had been asked by the hospital to check a piece of equipment which had been in use when a patient died. Subsequently, I was called by the coroners court as an 'expert' witness to give evidence on my findings. This was an interesting, but definitely not a pleasant experience, and I wouldn't recommend it to anyone.

Hi,nice to hear diiferent ideas.
Think about a hospital were we have more than 3000 assets(now I am refering to hospital in india where I was working before) and all the models are different.Do you think all the service manual will be available?If available also will it be possible to use all different chacklist for the PMs.Probably we will have around 400PM in a month and refering service manual and manufacturer checklist to perform PM will be a huge task,unless we have a maintanance contract with the supplier.The checking procedure for most of the medical equipments are same,any model you take the items whatever you check for a defibrillator or infusion pump etc will be the same.I strongly feel its easy and good to follow some common check list(for each type of equipment)for all models and manufacturers.Thats were I thought of ECRI's IPM procedures.How many of the suppliers are doing a proper PM with all test equipments and manufaturer checklist?I am not sure about in your cpuntries,but here in middle east or india the PMs done by the supplier usually documented with a single service report.

Hareesh,
I agree that common check lists are good. For a given type of equipment you need to check the same functions on all the models you have.
i.e. you check power output and battery capacity for a defib as part of the test routine.
But you then either have to know the equipment extremely well or have a sheet for each model to tell you how to do it. Each model will have a different way to access service mode for a battery test or it may be available from the user mode or even not at all. And different defibs might have different recommended energy tests. I do not think it is safe to assume all those doing the tests can remember how to operate each model in detail.
I am affraid it is not possible to write a generic test routine that ocvers all models. You can write what a particular type of equipment needs to have tested but then modify it to give the correct instructions for each model. Then you have the problem of optional extras i.e. defibs with 12 lead ECG, pulse-oximetry etc.
I personally do not thing their is a quick easy way to get around a lot of paperwork.
Sorry
Robert

Hareesh,

I reckon that the ECRI I/PM system is the “gold standard”. Trouble is that it does not cover every bit of kit (as far as I recall). But they still provide an excellent model, or template, on which to develop your own procedures. I suggest using these as the baseline, generic documents, together with a simple (eg, on one page) checklist for each type of equipment (ie, for each different model). This method actually works.

It can all be on a computer, of course. But it’s nice to have your binder of checklists (on your biomed cart, of course) with you when you’re out and about doing the PM’s (I ask, once again, how many people actually do this?). Where the computer really scores is in organising the schedule, PM dates etc.

If anybody, anywhere, needs someone to give them a hand in setting up this sort of thing, I am always available. Over the years, I have been interested also in developing a set of “definitive” PM procedures. Now that I have a bit of time, I really should get down and finish off that particular project. Anyone have any clues there?

At the end of October last year I attended a session with ECRI and one of the things we were told was that ECRI had been in touch with a firm of legal experts in the field of medical cases.
The question about prosecuting a case against someone who had not followed the manufacturers procedures was asked. The advice given (as I remember it) was that provided that a proper risk assessment had been done and recorded, it would be unlikely that a prosecution would result. Of course that doesn't mean you won't end up in court!

Is any-one from ECRI (or at the session) reading this, availlable to confim, deny or correct my memory.

Just be careful.
PPM is an estates based procedure.

for medical Equipment you should be using PVI, performance verification Inspection.

The suppliers recommendations must be followed, unless your Risk Team have discussed and agreed a variation to the procedure and you have signed the new protocols.

The Clinical Governance team must also be informed.

you should also, for record, write to the supplier and inform them about the decision your Trust has taken to for example, not to do PVIs 4 times p.a. but twice.

You also have be careful about using words such as "Prosecution". In the Medico Legal world, it is difficult to prosecute, because CPS are one of the bodides who prosecute due to a criminal activity, or recommend to police to take action.

in the event of a patient death due to an error in the use of a medical device or a belief that there was diviatin from practice or competency, the Police may interview individual staff "Under Caution".

The trust will also be critised for a mistake or not following procedures but will not be prosecuted.

in any event, and in the worst case, an MTO or head of department will be asked via the Trust Legal Advisor, to stand as witness (very rarely) that this happens.

It is the Trust who will ask for statements and settle the claim in or out of the court. The Trust may also suspend the individuals, but not PROSECUTE.

I hope this helps.

the legal field is very comlicated and use of words must be relevant.

alex Zarneh
Medical Physics
Mid Yorkshire NHS Trust

Alex

The Medical Device Directive is enacted into UK Law as the Medical Devices Regulation under a Statutory Instrument which means any breaches can be prosecuted. Failing to maintain in accordance with the MDD is a breach and therefore a breach of the MDR. The worst case scenario is that whoever is responsible for the breach whether it is the Trust or an individual CAN be prosecuted. Breaches may not be criminal but they are against UK law and therefore punishable by the courts. The MHRA assume the responsibility of the police for the MDR as the UK Competent Authority (trying not to laugh as I type)

As you say the legal field is complicated which is why the MHRA won't make definative statements and point us in the direction of the courts and our own lawyers. Look at the French who have raised prosecutions against manufacturers and the healthcare profession for breaches of the MDD.

We cannot get complacent and assume that we will not face legal consequences, the fact of the matter is we just don't know what the punishments are if an incident occured and we did not follow the manufacturers recommendation even though it is obviously to us that it was not the cause of the incident.

Unfortunately we are working in a field where we must cover our backs, this is the consequence of the public taking more readily to legal action.

Also I raised the issue of varying maintenace schedules with the MHRA in the past. Basically they said if we get written confirmation from the manufacturer accepting our revised procedures then we would not fall foul of the MDR. We approached a few pump manufacturers in the past and were informed that they have passed it on to there regulatory affairs and legal team, 2 years on we are still waiting for a response.