EBME Forums Forums Management Medical Equipment Management Neurotherm NT2000 - RF Lesion Generator

I believe that there are several of these devices, throughout the NHS in the UK. As part of our device evaluation, technical and clinical assessment, the PPQ form has come back as a 'NO' to question 5 (six sections of the same)of the said form.

I have taken this issue up with the UK arm of Neurotherm and I have discussed this with the USA manufacturer. They have informed me that they have not supplied or even been asked for, a service manual, by any of their UK NHS BioMed customers.

Is this correct, as I can not believe, that none of my learned colleagues have requested such standard technical documentation? How is the device evaluated against a specification, tested on receipt, repair and preventative maintenance checks. Spares and replacement parts, calibration, etc. all are necessary tasks, which one would expect throughout the devices usable life.

Medical devices management and maintenance includes the need for a 'service manual', that is why the question is included on the PPQ form and its predecessors, MLQ, EMQ. Surely one of my colleagues within the NHS has requested this manual and does so for all medical device intended purchases (pre-purchase questionnaire)?

www.neurotherm.com

Thanks

Jim Gavin EBME Manager
The Countess of Chester Hospital NHS Trust

We request a service manual with every purchase, I prefer to get the operators and service manuals either in pdf or cd format.

All technical documents. User manual,service manual,calibration certificate must include in the package..
In case to case bases, when it comes to court,what kind/type of repair/calibration did you do? Our answer is: We carefully follow what is stated in the service manual.

Hi Jim

I think that US companies are often like this about manuals. (General gripe, not specific to Neurotherm).

If they are selling inside the EEC, according to reliable contacts I made at BSI and MHRA, they *must* provide documentation as per the Council of the European Communities directive 93/42/EEC, Concerning Medical Devices. I have even printed off a copy for myself with handy tab labels to quote to those who hope to shirk it! There should be a link here: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:en:HTML

I was having trouble getting hold of service manuals for audiometers, and also the passwords required on some machines to get into calibration mode. The gentleman at BSI says that Section 13 - Information provided by the manufacturer - and specifically section 6.d of same, obliges any company wishing to sell medical devices in European countries, UK included, to provide installation and service information.

To quote this in full, Section 13.6 states that

"Where appropriate, the instructions for use must contain the following particulars: [...]
(d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safety at all times;"

I thought that this looked a bit weak, in that there could be endless arguments over what constituted "where appropriate", and that the company could simply say "it needs recalibrating every six months" without explaining how to do it. Though I was assured that any authorities on the matter would take a dim view of a company trying to wriggle out of providing the information like that!

I have since had very good results in getting hold of previously with-held information on this understanding of the EEC law.

IIRC, Neurotherm will not train local biomeds anywhere, and do not have any technicians in the UK. For the annual PPM the equipment must be shipped back to them in the USA and a loan machine will be provided. I don't know how many they will have for this purpose, but that would bear finding out before you commit to a purchase.

Oh, and Neurotherm HAVE been asked for manuals before, we asked them. They gave us the same line about never having been asked before...

And the moral of the story?

Check all this out before you buy the kit!

Thanks for all of the replies.

Well done Clare, I am absolutely impressed, we need more out there like you. I have a list of hospitals in the UK whom have purchased this device. I do not see any point in contacting them on this matter, as clearly they are not in the driving seat regarding medical device management and maintenance.

I wonder how they think they evaluated, commissioned, tested or confirm on-going calibration/operation? Though, I suspect that I know the real answer to that one.

Quite right Geoff and that is what I am doing. It is a pity that my learned colleagues did not go through this process before buying. Now I have had to pick up the tab and spend precious time on this matter.

Thanks guys!

Jim Gavin EBME Manager
The Countess of Chester Hospital NHS Trust