EBME Forums Forums Management Medical Equipment Management Out sourcing for medical equipment testing

Very constructive and helpful post Geoff. As a suggestion, maybe try not picking peoples posts to pieces and complicating things from a simple question?

Just a suggestion..

Good day

So you know better than the manufacturers? If a manufacturer says you need to replace a wire rope every 3 years do you think they are saying this just to generate work? Of course not! There are many parts that need periodic replacement to ensure the continued reliability and safety of the medical equipment. Failure to carry out proper service work may well result in a reportable incident.

It seems you are just enticing cash strapped NHS managers to use your services even though they fail to ensure the equipment will be as reliable and safe as a proper contract.

It is similar to 3rd parties using non-OEM parts to repair equipment and therefore invalidating the medical device directive (CE marking). (Use of parts other than those directly specified by the manufacturer mean the equipment becomes re-furbished and requires full CE re-certification!)

You were doing so well there, Mike ... until I got to the final paragraph, that is.

Hi Lee,
Careful, you don't want to get on the wrong side of Geoff, although his bark is sometimes worse than his bite!
I will take issue with a couple of points though. "The first stand alone company that started calibration and testing in the UK" and "been established for 9 years". We've been doing it for 12 years and I can name a few were around long before that.
I do agree with Mike re changing parts as per manufacturers guidelines, manuals etc. They are specified for a reason (invariably patient/user safety) and to do otherwise does not seem logical especially when you read other posts concerning registration and liability (the hot topic of the month). Testing on it's own seems like half a job if the unit is not serviced first even in basic equipment e.g a nebulisers output flow and pressure will change when the inlet filter is replaced.
Anyway good luck and hopefully Geoff will re enter for round three.
Ed

You know me, Ed:- "slow to anger, quick to praise" ... and I would never hit a man when he's down (especially if he was "new"). No-one gets anything less than a fair crack (but not more); and sometimes the troops need to be jollied along a bit, do they not?

Many NHS trusts use the likes of batteries, ECG Leads SPO2 sensors which are non OEM with no significant performance issues and and a much more attractive price tag!

Indeed, Billy.

But there's a world of difference between "SPOT" testers (and the like) and Bowden cables supporting overhead x-ray tubes and image intensifiers (or whatever it was Mike had in mind).

For me, that's always been one of the interesting aspects of working with (on) "medical equipment":- it's sheer diversity!

As I may have said many times before, it's up to the biomed (you know, the experienced, skilled, type) to determine when it's prudent and (or) appropriate to fit parts and "accessories" from "second sources".

Only if you "bring it to market". CE marking is not a safety mark it is a commercial thing, the idea of it was to ensure that goods made in the whole of the EU were made to the same standard and that countries where labour was cheaper (usually in southern Europe) did not under cut those made in areas where labour is more expensive.
So if you totally rebuild something with lots of different parts but continue to use it in your own organisation you do not need to CE mark it. i.e. you do not have to use OEM parts.
Robert

PS If you are going to blindly follow the manufacturers instructions to the letter why are you in a job? Surely you just put everything out to contract? It is much easier to manage outsourced contracts than staff and the costs associated with them such as training holidays and sick leave.

I believe you are only "required" to resubmit if performance parameters have changed due to deliberate modification. Replacing a resistor on the main board with one from RS should be OK!

But your last point is interesting, Robert. I have known places where the policy was to do just that (ie, farm everything out). The trouble was they could not find any "company" to take on some of the kit - especially the "minor" stuff (too old, too unusual ... too difficult, couldn't source spares, no manuals etc., etc.). In fact, that's why I was involved (you know, to take care of all the crap)!

But that way what you often end up with is a mess of service contracts (various dates, various levels of service, various qualities, various prices, always on the 'phone trying to get "them" to come in ... and all the rest). So the next step is to bring in a Managed Equipment Services company to manage the whole thing on your behalf. Only then (you hope) can you sit back and relax - with just the one "company" for you to keep tabs on!

And to reiterate my point, only if you are "bringing it to market"

You can manufacture a device from scratch and use it within your own organisation without any CE marking. That is the ultimate in using non-OEM parts.

Robert