EBME Forums Forums Management Medical Equipment Management Alternative replacement parts

I've done a search of the forums & surprisingly found no mention of using alternative replacement parts from 3rd parties - if I am wrong forgive me.

On to my question - does anybody have any views on using spares from a 3rd party? For example, it is possible to buy ECG cables from somebody else other than the OEM. In our case here we can purchase 5 lead ECG cables & leadwires for less than half the price of the OEM. There are also other examples involving SPO2 probes, SPO2 extension cables, batteries & temperature probes.

Batteries tend to be bit easier because you know that you are getting the same cells in different packaging.

SPO2 probes - well, eventually the OEM have given us them at a price we are happy to pay!

We do some assessment of the product & the viability of using an alternative spare (I do realise what the MDA have to say on this issue) & come to a decision.

I feel that now some formal evaluation & risk assessment is required.

Has anybody else any views/experience of this?

Regards,Mark

We use 3rd party suppliers for things such as ECG cables, SPO2 probes, batteries etc and I have no sleepless nights over the worry of using them.

I think the MDA pitch is more aimed at "working" parts of the equipment as opposed to peripherals.

I ask myself the question, If everyone is using OEM parts, including peripherals, how come these 3rd party companies are in business?

If they are not supplying to anyone, where are they making their money?

Had this one out a few months ago, we normally receive a written statement from the supplier/manufacturer that the “spurious” parts they are providing are of similar or better quality than the original and that they are suitable “FOR MEDICAL USE” these companies (O2 cells, batteries, SPO2 cells etc.) are usually only to happy to provide this documentation. It is companies like this that limit the “rip-off” factor. Yes, gentlemen, the KPO (here we go again) charge over 10 quid for a PP3 battery. Dear me. As Dave says Says it all my co-functional’s, says it all
L3

I am quite happy using these spares/peripherals in the knowledge that I have used my professional judgement soundly. However, I was wondering if anybody documented this.

I was considering some sort of mini evaluation including risk assessment using the following template:

Description
Features
Comparison to existing methods
Technical Evaluation including:
Compatibility
CE marking
Comparison/Test Results
Risk assessment
Advanytages
Disadvantages
Support (guarantee/availability)
Life expectancy (MTBF?)
User Evaluation including:
Fitness for purpose
Decontamination issues
Usability
Conclusion


Has anybody anything to say/add to this?

Mark

Mark,
I agree with your list for assessing a longterm suuply of ECG leads or pulse-oximeter probes from a third source but for a resistor from RS?
If we use a replacement component I add another section to a list I keep saying why it was purchased instead of the manufacturers part and giving details of each part. In this way I am not neglagent but can show I have assessed the situation. I also have blanket acceptance such as "identical" semi-conductors or discrete components from an approved (ISO9000 hence tracable) supplier. But then comes the definition of "identical".....
Sometimes it does seem easier to pay the price of a PCB than go through hoops to order a component.
Robert

Do you include cost in this assessment Mark? - surely you do, otherwise you would go to the OEM in most cases if cost was not at issue - is this not the driving force to go to non-OEM suppliers ultimately? (I know you are discussing assessment and I think your list is comprehensive but cost isn't mentioned as far as I can see). I suppose this should not be the over-riding factor but I think it can be, in practice, unfortunately.

Surely it’s all about uncompromised safety at a lower cost. Isn’t it ?

Louis III

RL - You are absolutely correct, cost is an issue. If the peripheral wasn't significantly cheaper than the OEM's, I wouldn't even be considering it!

But ultimately it's a cost versus quality issue - if it's cheaper & it works as well as or better than the OEM, then surely I am giving the NHS value by "spending public money wisely" (I hate to think what the OEM's would say about this )

Mark

Nah, it makes sense to search for a cheaper, siutable, alternative Mark. I think most departments do.

Manufacturers rarely manufacture anything without having to use a 3rd party supplier for ready made bits such as ecg cables, cuffs, finger sensors, etc. even if they are badged as their own.
'The pot calling the kettle black'??

We should use alternatives to reduce cost where is is safe to do so and does not compromise the quality of care.