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KM Offline
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Bearing in mind all the above. What about if the 3rd party supplier actually advertises their batteries as for example
For xxxx manufacturers yyyy ventilator?
My legal advice (a QC) is that in a court of law the 3rd party would be liable if you could proove you bought the batteries as per the 3rd partys statement.
Therfore if you have relevant 3rd party literature that is directly linked to the batteries fitted you are covered. As its upto the 3rd party to ensure the batteries are fit for purpose. Especially if the 3rd party is a proven NHS supplier.

M
Mr R J Ling
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Mr R J Ling
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Quote:
Yes, but Richard if four companies sell you the same model of battery from the same battery manufacturer as long as they haven't been modified after dispatch from the supplier surely they should be the same?

I guess that's up to you as the purchaser to find out from the supplier. OEM manufacturers are expected to provide full specs on batteries used in their devices to 3rd parties so that they can manufacture equivalent and fully compatible batteries to replace them with.

The use of generic smart batteries in safety-critical applications, e.g. for defibrillators shouldn't really be an issue if the OEM recommended batteries are also generic. P9 DB2005(3) "Guidance on the Safe and Effective use of Battries and Chargers for Medical Devices" states:

Quote:
The manufacturer should provide the battery specification so that suitable replacement batteries can be purchased from third party suppliers.

A battery manufacturer/supplier should be able to obtain the relevant information and provide batteries and importantly the evidence to support that they are equivalent and fully compatible to the OEM device manufacturers specification and it's up to the purchaser to ensure that they are.

We're always going to face the problem that if the cheaper equivalent batteries are not as good, in terms of performance and/or manufacture, etc, in comparison to the more expensive OEM device manufacturer sourced ones - then being equivalent, compatible, and making savings, is irrelevant.

Quote:
If not I think there's a serious problem since staff have responsibility for the conditioning these, they are probably going to get mixed up and since they will have identical part numbers there will be no way of telling them apart!

Because of this I'd suggest that battery management includes labelling packs with supplier ID, purchase details, warranty expiry and references to the actual product ID recognised by the supplier rather than the generic number applied to packs. For traceability purposes if there are issues.

M
Mr R J Ling
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Hi KM,

Chris seems to be referring to the use of generic smart packs with equivalent battery part numbers that I guess are not listed in catalogues for use with particular medical devices - otherwise we wouldn't be having this discussion.

I reckon purchasers leave themselves vulnerable if they are reliant upon the generic part number on the side of batteries from different sources that're not specifically intended for medical applications; based on variations in performance and characteristics of batteries generally speaking.

Quote:
Therfore if you have relevant 3rd party literature that is directly linked to the batteries fitted you are covered.

Not sure what you mean here - would the battery supplier be willing to fully indemnify the purchaser against all eventualities? I doubt it. Perhaps the terms and conditions of sale need to be obtained beforehand?

I suggest that in the end it's up to whoever fits the batteries, whether they follow the manufacturer's recommendations to use their batteries, or not, and that ensuring a 3rd parties batteries are equivalent is an attempt to mitigate the fact that manufacturers recommendations are not necessarily being followed, with regard to battery replacement?

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Philosopher
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Richard what I'm talking about is battery manufactures like Moltech and the likes who produce a generic smartcell like the NJ1020HP and similar ranges which they produce in both their own brand and without a label for other device manufactures to put their own labels on.

Now if you could confirm that someone like EuroEnergy or Medgraphic were purchasing Moltech batteries and just programming the E2proms and they confirm they are equivilent, there would be slightly less risk than say purchasing a custom battery like the FR2 battery from a them.

Further more when purchasing batteries if you could confirm that Philips or another supplier used bog standard NJ1020HP it does raise the possibility of going direct to Moltech

M
Mr R J Ling
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M
There's guidance from the MHRA on this; maybe you've read it. Personally I wouldn't rely on a sales brochure or technical person giving me verbal assurances if I were going to install generic or custom packs into all our defibrillators for example. Not that I have the authority to do so anyhow.

I'd need some evidence that the batteries are not just compatible that they are "equivalent" and "fit for purpose", i.e. they have performance and characteristics that meet or exceed the medical device manufacturers origninal battery specification; as well as being "compatible".

You have to be careful what suppliers mean by "compatible" and obtain the information that proves that the battery is "like for like" in terms of specification. For example a compatible battery may work but its specified lifetime may be shorter than the original battery specification.

In my opinion you can't assume that all suppliers will be sourcing a particular type of generic battery from the same manufacturer. Even if the generic number on the side of the pack appears to be the same. Specifications may vary between similar batteries from different manufacturers.

I would be more inclined to ask Euroenergy why they don't manufacture their own medical-grade equivalent for the NJ1020HP since they appear to be highly reputable, registered with the MHRA as a medical battery manufacturer and guarantee batteries for 2 years. I'd still ask questions though!

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Meanwhile... Here's an interesting NHS puchasing link for you all to ponder...

http://www.nhspurchasing.com/brochome.asp?OrgCode=167279&header=product

confused

And another one...

http://www.nhspurchasing.com/supplierinfo.asp?OrgCode=167279&supptype=ebroc

smile

Last edited by John Stewart; 15/10/07 2:48 PM.

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Super Hero
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Nice links, John. Official policy, we presume. So that's it, then! QED smile

Last edited by Geoff Hannis; 15/10/07 3:27 PM. Reason: quod erat démōnstrandum

If you don't inspect ... don't expect.
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Originally Posted By: Geoff Hannis
Nice links, John. Official policy, we presume. So that's it, then! QED smile

Kinda looks like it Geoff... Just wish I'd remembered about them earlier! grin


There are things that are known and there are things that are unknown. In-between there are doors.
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Super Hero
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What, and spoil Chris' and Richard's fun? wink


If you don't inspect ... don't expect.
M
Mr R J Ling
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I'm impressed but not that impressed. See any safety-critical device batteries there Geoff - defibrillators and suchlike? Good link but I'd still make sure I was getting like for like - makes sense given that NHS purchasing won't be fitting or using the batteries.

Is NHS purchasing advertising or recommending? When I get into work later in the week I shall contact them and MHRA and ask which it is. If NHS purchasing is recommending then perhaps this means we don't need to purchase from the manufacturer at all and that some policy has actually been agreed across the NHS.

As an aside on the website at the bottom of the page it states:
Quote:
nhspurchasing is an electronic procurement channel which is completely independent.

What are they independent of I wonder? I guess they're just putting together business links without a clue what's going on...policy? I doubt it's anything that organised.

10 products or thereabouts listed - 2 smart pack types NimH? the other 5 smart Li-Ion packs? Not sure about the other 2 types, probably NimH for the MPS? All appear to be American manufactured "legacy" products of a few years old.

I wonder if the battery manufacturer can give the information that's required, as recommended? Not that I don't trust NHS supplies or PASA rolleyes it's my nature to be cautious. We could ask Inspired Energy the battery manufacturer in the US perhaps.

Especially as there's plenty of stuff in NHS logistics catalogue that when I've enquired of the manufacturer it's not intended for clinical professional use, e.g. pen-type thermometers, battery operated NBP monitors, etc, because of calibration issues and inability to service/decontaminate/sterilize.

PS John & Geoff:

Got this extract from the Inspired Energy battery manufacturer website - STANDARD CONDITIONS OF SALE OF INSPIRED ENERGY,INC. ("Company")

Quote:
10. LIMITATION OF LIABILITY AND INDEMNITIES
Unless otherwise agreed in writing by a duly authorized Company representative, products sold hereunder are not intended for use in connection with any nuclear facility or activity, military application or medical device (as defined by the Food and Drug Administration). If so used and any damage, injury of contamination occurs, the Company disclaims any responsibility of every kind, and Purchaser shall indemnify the Company from any such damage, injury or contamination whatsoever arising out of any such use, including such damage, injury or contamination arising out of the Company's negligence. The Company also disclaims any responsibility and Purchaser shall indemnify the Company from any and all liability of any loss or damage or judgment whatever arising out of any unauthorized modification or adaptation of the product sold hereunder and the installation of any device, instrument or equipment or part thereof in or on the products sold hereunder, the use or combination of which has not been proven. In no event, whether as a result of breach of contract, warranty or tort (including negligence), shall the Company or its suppliers be liable or any consequential or incidental damages, including but not limited to loss of profit or revenues, loss of use of the products or any associated equipment, damage to associated equipment, cost of capital, cost of substitute products, facilities, service or replacement power, downtime costs, or claims of Purchaser's customers, for such damages.If Purchaser transfers title to or leases the products sold hereunder to any third party, Purchaser shall obtain from such third party a provision affording the Company and its suppliers the protection of the preceding sentence.Except as provided in the article entitled "Patents" the Company's liability on any claim of any kind (including negligence) for any loss or damage arising out of, or resulting from this agreement, or from the performance or breach thereof, or from the products or services furnished hereunder, shall in no case exceed the price of the specific product which gives rise to the claim. Except as to title, any such liability shall terminate upon the expiration of the warranty period specified under heading, "Warranties." If the Company, without separate compensation therefore, furnishes Purchaser with advice or other assistance concerning any product supplied hereunder or any system or equipment in which any such product may be installed which is not required pursuant to this agreement, the furnishing of such advice or assistance will not subject the Company to any liability, whether in contract, warranty, tort (including negligence) or otherwise. Each of the foregoing paragraphs in this article will apply to the full extent permitted by law. The invalidity, in whole or part, of any paragraph will not affect the remainder of such paragraph or any other paragraph.

Worrying that the company that makes these batteries dosn't accept any liability if they're used in medical devices in the USA, at least. Can't blame them in these litigious times I suppose.

But hang-on, just had a thought, don't they supply Moltech Power Systems in the UK with this range of batteries? Or does Moltech Power Systems also manufacture in the EU?

I wonder if there are similar conditions of sale in the EU? If not, why not, if they're not for use in medical devices, without special authorisation, in the USA? Does this mean different specification batteries or just different laws?

In the USA they don't appear to be intended for use in medical devices according the the conditions of sale. Wonder what's different in the EU?

Perhaps I should contact the MHRA and ask them to see what Moltech Power Systems standard conditions of sale are when selling-on or manufacturing the Inspired Energy range of batteries for medical applications, eh?

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