EBME Forums Forums Maintenance Spare Parts CME T34 Internal Battery

give them a call, not in the catalogue as not many people have sourced it from them before, not sure of exact price, but it was under a fiver

The Medical Device Directive is an EU document (or set of documents). I believe that the idea behind it is to facilitate the free movement of new medical devices within the member states of the European Union; in other words, the EU market. I could be wrong, but I don't think it mentions maintenance very much.

Now I'm wondering - how come kit made outside of the EU - USA, China, Israel et al - gets a free ride (CE marked, and all the rest)?

Do we suppose that all medical kit has to undergo Type Testing before being released into the EU market? Or is it just a question of paperwork, and (or) the payment of extra tariffs? After all, the FDA are already pretty tough on new kit coming into the US market - "equal to, or better than" (probably the latter) the EU, I would have thought.

Yes.

Am I right in assuming that these batteries are simply for data (config) retention purposes? I wonder where the factory in Israel sources them from, and how much they (and the factory) would charge. They are the OEM, after all.

These parts are a copy and therefore not approved by the OEM. Just because Medgraphics are ISO 9001 registered does not mean they conform to MDR and ISO 13485.

Yes, most likely! If you report to the supplier a batch of lamps explode after 20 hours use and have required patients examinations to be repeated how will they report this to all other customers? An OEM would issue a field safety notice for all users.

They will only have 9001 certificates and not the higher level for medical devices, such as 13485. How do you know they are made in the same factory and to the same specifications? Did the OEM provide you with this information? Again if a fault occurs how will the supplier inform all others of the issue? I doubt they even know who they sold them to!

It may sound like that but the cost is justified when you understand the legal obligations medical device manufacturers are under. As always, until something happens and it results in a court case will you find out if the cost savings you think you are making are real savings or just “chancing your luck”.

I can't argue with any of that, Mike ... from the legal point of view, that is.

However ... I would point out that over the years we have heard a lot here on the forum about "court cases" and so forth - but I don't recall any examples of such cases actually being cited.

Meanwhile - any one else remember (the concept of) "Risk Assessment"?

Geoff, you don’t hear about many court cases as they are often settled out of court to avoid publicly!

I do know of some coroners court rulings that have required some changes to safety standards, such as the need for metal clad consumer units, and changes to guidance regarding socket-outlets in medical locations (see HTM 06-01). However, the information is not easy to come by unless you get directly involved with the incidents, consequences or changes to standards, etc.

Fair enough ... but neither have I heard of such incidents resulting in anyone being struck off the infamous "Register"!*

"Paper Tiger(s)" is the phrase that comes to mind.

* No doubt my contacts into the grapevine are not as strong as they once were.

The T34 states "made in Germany" on the label. I guess they make all the component parts in Israel, then ship them into Germany at low value to reduce EU tariff charges, assemble in Germany, where "the value is added" so that it then meets EU rules and CE marking rules.

from the CME website

"CME Medical operates a quality management system which is certified to ISO 9001. In addition, our technical service department has achieved ISO 13485 certification. To find out more, visit Quality and regulatory."

So looks like manufacture is ISO9001, but service is 13845, so the original fitted batteries will only be supplied to 9001...

The T34 specifications states:

So to maintain the CE marking you have to fit parts supplied by the OEM. You can't just use parts supplied by a company following ISO 9001 and assume you have not affected the CE marking or safety of the device.