EBME Forums
Posted By: Nozza OEM service - 10/03/21 10:41 AM
Hey everyone

Long time no post, couple of quick questions if you don’t mind.

If an OEM was installing a piece of equipment would you expect them to carry out an on-site EST, or do your site policy mean you would have to carry one out anyway?

If you were receiving a free PPM would you expect OEM to provide EST?

If you were paying for an OEM repair would you expect an EST?

If anyone knows of a policy, standard or regulation that says and OEM is required to carry out an on-site EST it would be much appreciated.

Thanks
Posted By: Geoff Hannis Re: OEM service - 10/03/21 4:25 PM
When you say "installing" ... are you referring to a fixed item of equipment?

In general, I would want to do the EST myself - it should be part of the in-house acceptance procedure, anyway.

If I was paying for the service (any service, in fact), I would make my requirements clear on the Purchase Order.

"Free PM" ... what's that?

The hospital should have its own written policies regarding this, and many other matters.

But what we really want to know is:- are you the in-house biomed or the OEM contractor in this saga?
Posted By: Nozza Re: OEM service - 11/03/21 9:43 AM
Hi Geoff

Thanks for your response.

Definitely in the world of EBME/ NHS I would expect some sort of acceptance tests to be carried out as an OEM engineer in a previous role I saw a mixed bag, some places did want an EST, some wanted to carry out their own.

In the private sector of hospitals don’t really see much policy or procedure around acceptance test and it appears it’s up to the OEM to provide whatever they provide. Unless they have an on-site engineer.

I suppose ‘Free PM’ is a bit misleading you would have paid for it at some point through consumables or capital cost. But a device that you don’t own in situ through a trial (clinical not device) or a rented device etc.

It would be white box goods so portable medical equipment well as portable as a theatre microscope or anaesthetic machine is. Some assembly required so installation included with supply.

At the moment I work for neither really but I want to prepare an OEM for service delivery.
Posted By: Howard Re: OEM service - 11/03/21 1:32 PM
Hi Nozza, in my time as a technical sales engineer, the 'installer' (normally the sales rep) does not carry a EST with them, so they cant do that. It should have an EST test in the factory, and results included in with the device, but that test may not have been done with the same mains cable as you received.

In the EBME's I visit they mainly use their own tester, as you cannot guarantee (without seeing the test certs or calibration label) that the device used is in calibration. The hospital EBME then have to say they checked these are in date.

Yes every repair, if they opened the device should have an EST, if you compromise the electrical safety it must be tested prior to being put back into service.

When I supplied service contracts (and when in the NHS) the contract always stated that an EST must be performed to XYZ standard and results given. Some EBME's wont sign off a repair or PM unless a written safety test result is seen (paper or emailed).
As far as I know there is no regulation, but the person performing the PM, or repair must ensure the device is safe to use, if they dont and something goes wrong, where does the blame lie?
Posted By: Geoff Hannis Re: OEM service - 11/03/21 2:40 PM
@Nozza: yes; in short the in-house biomed should be the "custodian of electrical safety". There is always a degree of risk associated with any equipment failure; that's why PM was "invented"!

"Free PM" ... yes; typically lab analyzers that may be effectively leased from the OEM or their agent. I came across a lot of instances of that overseas, and (to be honest) did not touch those machines myself (just an inventory check). Even the operators (lab techs) would not let me near them! The deal was that the local service guy came in now and then to do whatever the OEM felt necessary. They also supplied the reagents (which was where the money was made, of course). I don't remember any problems. I don't recall even seeing the paperwork (service reports), which, in hindsight, was a little remiss of me (but in my own defence I had far greater things to concern myself with at that time).

MHRA Guidance (see below) mentions "loan equipment".

Private hospitals? In my (limited) experience of these in the UK, I would say that in-house tech support can be "patchy" at best! In overseas locations it can range from "nil" to "best international practise" (in other words, it all depends on what money is available - as well as, in some cases, the attitudes of the owners).

@Howard: BS EN 62353:2014 gets a mention by the MHRA ... hopefully NHS sites follow that "official guidance".
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