EBME Forums Forums Management Medical Equipment Management Oem obligations

Can anyone advise me on whether oem's or their agents have a legal obligation to supply parts to us, the owners of the medical equipment if we request them?
i've experienced issues in the past where some will refuse to provide parts, using the age old excuse of not been trained on whatever the particular item is, even if it is a basic piece of equipment! They are very willing though, to send one of there own engineers to squirt some lemon fresh on it and put a "service sticker" on it for a premium price.
A rep from a company recently mention that they have an obligation but can anyone clarify this? is there an official document that any of my more esteemed brethren can point me to so i can shove it in these hungry merchants faces?
Cheers in advance chaps/ettes.

It's an interesting question; and one that has never (as far as I am aware) really been put to bed in this forum!

It's something which (yet again) official Government Guidelines could easily adjudicate on ... but I don't recall any such words of comfort just at the moment.

On the other hand, feel free to wade through this lot (although I fear you would be wasting your time).

Over the years* I have heard various opinions banded about ... but I suspect that the real (legal) answer probably lies somewhere in Consumer Rights legislation. However, here is a quote lifted from this source:-


No Good News, there, then.

But note the so-called "Six Year Rule".

See also this earlier thread.

Meanwhile, the Management of Spare Parts for Biomedical Engineering Services (how's that for the title of a PhD thesis?) - as well as biomed logistics in general - has always interested me; so feel free to ponder (and hopefully, bring up to date) this ancient thread.

* In Saudi Arabia there used to be a (sensible) rule that parts had to remain available for purchase seven years beyond the initial (one year) warranty.

If I understand your position correctly, you are trying to bring as much maintenance as possible in-house - from a situation where most (if not all) was carried out by either OEM's engineers or third party service providers.

Well, we can't expect those guys to give up easily; revenue is going to be lost, after all. In other words (and as you have already mentioned) you may encounter difficulties in obtaining "support" (including spare parts) in future.

What you may want to do is take a hard look at each type of equipment within your domain, and then ascertain (estimate - guess) the likely future requirement for parts as the kit ages. Once you have such a list (which may, in fact, be not too long) you can set about obtaining those items (assuming that you have the necessary funds), and then holding them in stock. Your sourcing options could be:-

1) The OEM
2) The supplier
3) Third-party vendors

Source 3) could include service providers in the UK, Europe or the USA. The USA has a large third-party market for medical equipment parts.

You could also ask other ("friendly") hospitals to source parts on your behalf! Or even someone who has attended one of the training courses you have alluded to (the same goes for "difficult to obtain" manuals). And before anyone starts howling - just remember who actually owns your equipment.

There again, we need to distinguish between spare parts (for maintenance and repairs) and "consumable" items or accessories often swapped over by the user. I have in mind the usual examples of NIBP hoses, cuffs, SpO2 probes, ECG cables, ECG paper and what-have-you. As we know, there is a third-party market for such items, so we need not bother the OEM or (official) supplier with those.

And don't shy away (as I know some do) from using "generic" parts where appropriate. Batteries, and IEC mains cables for sure - but also many (almost all) components and such like when carrying out repairs. We are, after all, engineers - so we should be able to make engineering decisions!

Yes; "sticker maintenance" - no doubt we've all seen it.

On a historical note, I was lucky enough to be brought up in an era where we tried to ascertain ("scale") at the onset (as equipment was brought into service) the likely need for parts projected forward over the lifetime of equipment. In other words, we stocked parts at the various "lines" of maintenance (3rd, 2nd, 1st), with "ready use" items held close to the equipment concerned (that is, at 1st Line). Yes; it sounds (and sometimes was) expensive - but in the long run may not have been, as equipment was generally able to be kept going long after "support" had otherwise been withdrawn (manufacturers no longer around, etc.). I realise, of course that "modern (accounting) techniques" and Just-in-Time supply chains have rendered such attempts at good husbandry unfashionable, but maybe we need to return to such methods!

As always Geoff, thanks for the response. I'll have a look at the links provided later in the day.

I've been playing with the idea of adding the term to our tender offer to potential suppliers that they 'MUST supply technical training, support and parts' for the duration of the equipment life cycle of any product which we purchase going forward. They are more likely to agree with this term if it is the difference between winning or losing our tender. The hospital board of mgt seem to be in agreement with me on this as they see the cost savings from having it inhouse. I'm sick of the extortionate rates at which some OEM's/agents charge for menial tasks. If a garage asked for 350p/h to change an air filter on your car, what would you be likely to say?! I'm aware that there is some medical equipment kit which potentially justify their high rates, but for a lot of what we biomeds deal with on a day to day basis the high price is not justified.
I'll probably return to this thread in the coming months once I have everything up and running in the Biomed Dept. I'll keep you posted on how my "term" is going down during tenders as we have tenders going out in the near future.

rsysmexk, do you create individual specifications or a standard sheet, here I do all the specifications on an individual basis, the special terms and conditions (Arabic) include a period of 10 years that parts must be available, me I add training for the technicians, internal and external. There is also a statement that the equipment must be patient ready (accessories/consumables) upon delivery and that the consumables must be available for a minimum of 6 months and the delivery must be coordinated with the end-user.

As you have mentioned in your post you have used the word MUST and this is essential, I have seen a lot of tender specifications using the word SHOULD and to me this is too vague.

... don't forget to include:- "plus all available technical information* and [insert number required] copies of users' instructions".

This stuff should be standard practice!

* I used to expand this with "such as circuit diagrams, service manuals, maintenance and repair information, and parts lists" - but from what I have seen of a lot of the modern service manuals, they often do not have such detailed information anyway; hence the catch-all clause "all available" (as in:- whatever is available).

Ten years for parts, but only six months for consumables? Something's not right there, Neil.

Were you thinking of "shelf life"?

Also, what about "pipeline time" (time taken to deliver) - can we pin them down on that?

I know we all have stories about kit being "awaiting parts" for - err, years.

@Neil Porter
I've yet to enter my "term" on the tender documentation, but mgt, and probably more importantly, the CFO is interested in it as they see it as value in terms of cost and equipment uptime (no waiting for external engineers..) At the moment as I am super busy with setting up the Biomed Dept, I've suggest that the people who currently write the tenders include it as a minimum requirement. Only a couple of minutes ago, I've been told that we've got agreement from 1 of the big healthcare companies for pet/ct/mri with a cost saving of nearly 100k per year. We do ppm/1st line support, they'll provide us with training/documentation/phone support/parts and they will do the 2nd line support if needed. I'm happy with that news, its a good early result and hopefully a sign of things to come...

Once I've all my other ducks lined up here, I'll start drilling into other elements of tenders. I particularly like the way Lab contracts penalise agents who don't meet the tender specifications, it really ensures that service agents provide better service, but that's a job for some time in the future when I've got time to do it properly.

I'd be interested to discuss the topic of your individual specifications further Neil.
Do you have standard specification that you include in every individual specifications you generate? (a bit of an oxymoron there..)

Yes; that imaging deal is exactly how it should be done. Good work!

Meanwhile, you may need to distinguish between specifications for new equipment tenders, and "specifications" for service contracts.

To avoid confusion, you might want to use the term "templates" (as in:- "contract template") for the latter. Unlike most equipment specs, these can often be "boiler plate" (form documents) that, once nicely developed, can usually be used over and over again with little, or no, amendment.

Geoff, consumables will be added as stock item and ordered as required