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#60046 15/02/12 9:55 AM
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Do any of you who use the GMDN classification system?
If so do you have a decision tree to help with the classification of devices? Or a searchable database? Or any help at all.
Or a copy of ISO 15225:2010
Thanks
Robert


My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
RoJo #60054 15/02/12 2:56 PM
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Hi Robert,

The EU sets the classification of medical devices is based on MDD93/42/EEC (not GMDN) - just see and follow the rules in Article 9 in the link:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

GMDN gives a unique number to a device based on the description and its associated definition e.g. "Medical Air Terminal Unit" is defined as "A device that is a component of a medical gas pipeline system........................................", i.e. not a classification. You have to pay for the service to get an actual number and the rest(i.e. become a member). However if you are canny and use the Australian TGA site:

https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuDevices?OpenView

Details of many devices are there including GMDN and supplier classifications (be careful old registrations might give out of date GMDNs - since they get regularly updated or superseded). As to ISO 15225 - it's a copyright publication £136 from BSI (half price if a member).

I hope this helps.

Steve

RoJo #60056 15/02/12 3:54 PM
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I think I did not expess myself too well.
I am trying to search the GMDN list for equipment and cannot find certain simple things such as air mattresses - it does have have overlays. (I have paid for access to the official site)
I was wondering if anyone had a simple way of working out what heading things come under. If you start at the top and work down the tree (albeit an up side down one) I end up with not the item I wanted. there seems to be no logic at all in the groupings of equipment and there seems to be multiple paths to the same item. As you can tell I am new to this system and am struggling to understand it.
Any experienced people out there or is it really a mess as I am beginning to suspect?
I thought the collective terms were hierachical but it seems they are not. Am I right?
Robert


My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
RoJo #60060 15/02/12 6:54 PM
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Good luck with that Robert. I fear that your suspicions may be well founded. frown

I took a brief look at the thing a few years ago and, shall we say, failed to be impressed. But to be honest I didn't spend too much time on it once I noticed how much they were charging.

Frankly, my own "home grown" codes have always been good enough for anything that I have ever done, although I appreciate that you must be acting for some third party or other (that is, not free to pick and choose). frown


If you don't inspect ... don't expect.
RoJo #60072 16/02/12 10:09 AM
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Hi Robert
I have been using the GMDN for some time now and have just recently completed changing all our old medical device equipment codes to GMDN codes in our AIMS database. As the GMDN is being used more and more we felt this was the correct way to go.

There are still quite a few medical devices without GMDN codes but you can request that the manufacturers apply to the GMDN for codes to be created for their devices. I currently use 5 old codes to group devices not on GMDN into a general purpose category until new GMDN codes are set up.

I agree that finding the correct codes can be quite tricky at first but after using the system for some time you soon get a feel for what your search criteria should be. In the case of you’re ‘air mattresses’ you should not use plurals in the search just ‘air mattress’. This will bring up a selection of devices from which you can pick the most appropriate nomenclature and code.

At times the nomenclature will not even contain any of the search words, for your example above it gives… Flotation therapy bed, adult ... as one of the options with the device description as shown below…

A mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment. See also: Air-fluidized bed; Low-air-loss bed

As you can see at the end of the description it also gives alternatives to consider.

Despite what Geoff says this seems to be the way ahead as more and more countries and manufacturers are adopting the GMDN to name their medical devices.

I have found the people at the GMDN to very helpful in trying to trace codes when I have been stuck in finding the correct nomenclature in the past.

If you have any queries on finding other GMDN codes I would be only too happy to try and help you out if you email me. smile

John


There are things that are known and there are things that are unknown. In-between there are doors.
John Stewart #60075 16/02/12 11:40 AM
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There's nothing wrong with classifying and categorizing the kit, John ... and I say that having spent many hours (hundreds, thousands?) over the years doing just that ... just as long as the folk doing the classifying make a good job of it. smile

And I write as one who has suffered the consequences (usually in the form of extra - unnecessary - work) of it being done badly as well. Back in the army, for example (they were forever plonking lab kit under "general medical" ... and once the numbers had been assigned it was nigh-on impossible to get them corrected). And also on various overseas projects (they almost always got it wrong ... and we were forever having to "cross refer" to more sensible lists).

For those who have never tried it, I would advise that (just like writing specs) it's not as easy as it may first appear.

Don't forget that others have had a fair crack at it over the years. ECRI for example.

So, questions that come to mind are:-

1) Why not use the ECRI codes (they are in use worldwide)?
2) Who are these GMDN people anyway?
3) Are they a government agency (or a money spinning company)?
4) Do you want to rely on them (to be beholden to them)?
5) Can we be sure that they'll always be around?
6) How much does it all cost?
7) Why can't the National Health Service do this sort of thing for themselves (and have their own codes)?

Others tuning in may also be wondering:-

1) What are these guys talking about?
2) Why does the kit need to have codified anyway?
3) What purpose does it serve?
4) Does it relate to tech support and maintenance (or just "property control")?
5) Is it that important that (lots of) time needs to be found to carry it through?

... and stuff like that! think

Lastly (and it sounds like you have already done this, John) I would suggest that folk always retain a mechanism to be able to assign their own codes in cases where the "official" ones don't really fit ... or are just plain wrong!


If you don't inspect ... don't expect.
Geoff Hannis #60076 16/02/12 12:14 PM
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Geoff

1 ECRI are moving towards adopting GMDN codes
2 See GMDN website
3 No/This non-profit company, “GMDN Agency”, acting as the Maintenance Agency Secretariat (MAS), functions as the hub in the running and maintenance of the GMDN, providing services and information for access to the GMDN data through this present Internet site or other means. To ensure continuing permanency of the GMDN, revenues may be generated through the licensing or sale of GMDN Agency products and services, or by direct funding allocated by relevant global regulatory bodies or other parties.
4 As much as any other agency
5 Nothing is permanent
6 See GMDN website
7 The whole point is to create a Global Medical Device Nomenclature.

John


There are things that are known and there are things that are unknown. In-between there are doors.
RoJo #60083 16/02/12 5:01 PM
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@Geoff
6) approx. 800€ p.a. for a limited search (100 devices).

What information can we get from GMDN? I had a look at the website and came away with a sore head from trying to work out all the acronyms.

biomedbill #60084 16/02/12 8:33 PM
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I had better not say anything else, Bill, lest I get into "trouble" again with the Moderators. frown


If you don't inspect ... don't expect.
RoJo #60088 17/02/12 8:04 AM
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Just ask a nurse is it a Patient bed, Electric, a patient bed, mechanical! they don't care, when they report a bed faulty it is just a bed!! Our asset management system (home grown) will tell the tech if it is mechanical or not. No need for all the variations of beds, ultrasound machines etc, if your database can tell you the difference. One last thing will there be a different code for different software versions?


If you think hiring professionals is expensive, try hiring amateurs!
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