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#74264 17/06/19 5:12 PM
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Dear All,

Where do NHS trust's EBME departments stand legally when OEM's / companies refuse to provide spare parts?

I have been engaged with a particular company, for some time now, regarding parts for a syringe drive (the device and provider to remain nameless). When hastening a spare part purchase order with this provider, I established that the training only had a valid life of 2 years and despite us having two techs trained, albeit about 4 years ago, they insist will not provide parts until our training is brought up to date.

For complex and high risk devices, such as anaesthetic machines or ventilators, you could agree with this approach but for a syringe driver, where we have the service manual, a skilled and qualified workforce I completely disagree.

During one of the many emails, I explained the work force have recently been trained on at least 4 other syringe driver OEM training courses recently and transferrable skills must apply. I also explained that should we (but unfortunately our site love them) or another site ask me to recommend a similar product, I would steer them to a competitor but no joy.

Earlier this year and through gritted teeth, I was left with no alternative but to purchase another course at part of an order of more devices. I was given a course date in April but explained that we were undergoing a TUPE transfer and would like the course to be delayed until some time in June or July; when I knew what the staffing situation looked like. Since then we have been managing the fleet the best we can and I contacted them earlier today to arrange the training. The company explained that due to leave they could not fulfil our training request until, at least, September!

I have heard about companies being taken to court in the US for this but nothing in the UK or Europe. If anyone does know where I stand legally it would be greatly appreciated.

Best Regards

Matt

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Super Hero
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What does your Trust Chief Executive have to say about stuff like this? think

Why not just tell him/her that you cannot support the items in question, and let those (big earners) on the Top Table sort it out?

Meanwhile I yet again make the point that a properly organised National Health Service would (should) be able to source parts centrally and "in bulk". This should especially be the case for common items like syringe drivers. They should also be able to drive down prices (through negotiation and "economies of scale").

Plus they should be able to "flex muscles" (and intervene) when companies and/or suppliers try to pull the kind of scam to which you prefer.

It seems that many of these "companies that care" are only really interested in money. To confront them, you need to be able to hit them in the pocket. Hopefully this will become easier once the various so-called National Health Services become fully privatised. whistle


If you don't inspect ... don't expect.
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Sage
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Check the original signed Pre Purchase Questionnaire

At the time of purchase, the seller would have stated that they would make spare parts available to the syringe driver purchaser for up to 5 years after the model ceased production.
If there are no preconditions, its a black and white case.

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I have had a similar situation with a supplier of a syringe driver, despite during procurement being very helpful including supplying a copy of the service manual when i tried to order a battery cover it was refused as we had not had the manufacturers training. They even had the cheek to suggest the manual should be returned as we were not authorised.

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Super Hero
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Maybe the Answer here is to insist on technical training being part of the initial procurement package. think


If you don't inspect ... don't expect.
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Hi All,

Many thanks for your replies. However I was hoping someone may have had experience of this and any specific legal healthcare consumer advice.

The original devices were purchased before my time and there is no record in the PPQ log.

Also, as a rule, I do not purchase any equipment without foc training. However on this occasion the department would not deviate from this device and the company would not provide foc training, hence the paid training course; so I was left with no alternative.

Best regards

Matt

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The PPQ forms part of the tender unless you've agreed on the availability of parts your out on a limb. The only thing you could try is suggesting their products will be boycotted from the Trust if maintenance is not possible. MHRA Managing Medical Devices booklet is located here

Did have this problem with a portable ventilator once, at the end of a two year period they wouldn't supply parts without attendance on a £2500 refresher course, needless to say, we now use their competitor.

Apparently, it's the same principle that existed with Apple phones, some manufacturers want to authorise who services their equipment as problems won't be blamed on poor maintenance but instead on the product.

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Hero
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Legally (in Europe: MDD 93/42), the company only has to provide 'all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times.

There is currently no legal obligation to provide parts or service training, unless they have agreed that as part of the PAQ process.

Last edited by John Sandham; 02/07/19 12:02 PM.

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Super Hero
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Originally Posted by John Sandham

...unless they have agreed that as part of the PAQ process.


Yes, John; and that's why the biomeds should always have input into (or better still, be part of) the procurement process. smile

I dimly remember one place where we tried refusing to maintain any pieces of kit that hadn't been "signed off" by our predecessors at time of purchase. Naturally, we didn't get very far; but having made our point to the Hospital Management, we were always consulted when further purchases were planned.


If you don't inspect ... don't expect.
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We had the same with a well known ventilator company, our chief technician argued that as the training had not substantially changed, the devices had not changed since the initial training that they would be teaching an engineer with 30 years experience to to the same thing he did 2 years ago. He somehow won that, and might ask him how next week and see if it was any special rule he pulled on them.
I think you have to get them to demonstrate that this is a technical need and not a ransom to sell parts or service contracts.

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