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Hero
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Hero
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Louis
This may be 'pie in the sky'!
The MDA sounded confused when I asked about this document, but are looking into it and will phone me back later today.

I also phoned the DoH helpdesk, and drew a blank.
frown


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John, Louis has forwarded a copy of the afore mentioned e-mail that Louis received. Cast your minces over it and see what you make. John, to pass the CE standard:- a piece of equipment must be &#8220;classified&#8221;. Somebody must have a list. We compiled our list with the help of the manufacturer's, however; the list is only accurate for equipment < 5 years old. A little improvisation was required for other items but we had this procedure endorsed from the powers that be.

Louis wink


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كيف الآن يحمّر البقرة
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The classification you refer to for CE marking is the Risk classification.

Class 1 is low risk
Class 2a is medium risk
Class 2b is medium risk
Class 3 is high risk

Which class a manufacturer puts its equip in depends criteria set out in the MDD. You may recall that MDA sent all trusts a disk with a program called Classify, this enables users to determine which class a piece of equip falls into. Unfortunately I misplaced my disk years ago but somebody might still have it. Failing that it is not too difficult to workout the class using the MDD or the CE bulletins on the MDA website. Hope this helps.

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Sorry, finished this post without finishing.

How the classification works is that all equipment automatically starts on class 1, but manufacturers have to answer a serise of questions.

i.e. does device get used for channeling fluids into a body cavity if yes then Class 2b etc.

What class the equipment eventually gets classified determines how they get CE marking.

classification rules can be found on this link

http://www.medical-devices.gov.uk/mda/md...fd3//bull10.pdf

i.e. if Class 1 then company can self certify assuming its QA has been passed by notified body. Only Class 1 devices which are sterile or perform a measuring function need Notified Body (ie BSI) approval and have the 4 digit number assigned by the CE mark. If it has self certified then the 4 digit number is absent. There are many ways of obtaining CE marking even within each class category (I think Class 2a has at least 2 routes). Below is the link on how to get CE marking according to risk category.

Hope this makes sense

http://www.medical-devices.gov.uk/mda/md...7fd3//bull4.pdf

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Hero
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Louis,
Thanks for the message, I just received it.
I found the CE Risk classifications, and wonder about whether this 'manufacturing classifications' are entirely relevant to PPM scheduling from a risk perspective.

The CE risk classification is looking at the risk to the patient in the event of poor manufacture.

It is not looking at the risk to the patient in the event of not carrying out planned maintenance.

There are CE class III high risk devices such as implanted pacemakers which cannot receive a ppm.

or Class 1 low risk devices such as battery operated monophasic electrotherapy, which can cause electrolytic burns, which do need an annual ppm.

Do you combine the CE classification with some other cross check?


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Here is a link to the Medical Device Directive :
http://www.amtac.co.uk/MDD/mdd_directive.pdf
The classification criteria are in Annex IX.
Hope this helps.

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John

Who did you speak to at MDA earlier today? Did they work in Device Technology & Safety (DTS) or European Regulatory Affairs (ERA)? I suspect the correct section to talk to would be ERA as they would have known about Annex ix of the MDD. They would also know about the classify program I mentioned earlier, it came with all of the bright blue EC stuff that they sent out on mass in the mid 90's. Isn't it funny that which section you talk to within MDA (whether it is DTS, ERA or evaluation) determines the type of advice you get.

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Hero
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Bioman, Amanda,
I spoke to the MDA switchboard who put me through to the DoH helpdesk (who didn't help),but put back through to the MDA switchboard, who did then put me through to someone who said they would get back to me.
I got more help from you than I did from the MDA, but maybe I didn't make myself clear. I have had good advice in the past, just depends who you speak to I suppose.

Anyway, thanks for the links. I have a hard copy of MDD93/42. I'll have to dig it out and read it again. eek


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John, as Louis stated earlier, a little use of the grey matter is required. I agree, some equipment classification is a little ??? confused however, until a standard is produced, OR everyone can fulfill there PPM obligation, rolleyes then a system agreed within the trust has to suffice for now.... Also John, Louis is a little baffled, Louis has a copy of the CE classification and devices that exchange energy with the patient are "high risk". basically, our "other crosscheck" is good old "common sense".

Can Louis poll our fellow hombre's, here...

Who of you (if any) are up to date with your trusts entire equipment schedule?

Louis III


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كيف الآن يحمّر البقرة
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Louis,
I would have thought so, but the manufacturer put it through as a conventional battery operated TENS device, and it was accepted as such.
Without people like us to monitor the equipment as it enters use, these anomalies would not be found.

We audit our equipment schedule annually, but it can never be up to date, because equipment comes and goes, with and without our knowledge. Staff have protocols, but don't always stick to them.

We do our pm's 6 monthly in every area, minors and majors. This gives us a chance see most of the equipment we are responsible for. (Even if we can't service it all) Visual inspections are an important part of the work we do and we find quite a few problems. (Cracked cases etc)


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