Is there anyone co-ordinating research?

[GarethB]

Basically C3R can not be adopted universally as each country has its own regularoy authority.

In the Eu, the techneque needs CE approval, then in the uk it needs to go through the MHRA (Medicines & Healthcare Regulatory Agency), in the US it is the FDA, Australia is different again and so on.

There are some aspects of our system which are stricter than the FDA, but aspects of the FDA regs are stricter than ours.

With drugs or medical devices it is the responsibility of the manufacturer to get approval to sell their products in certain countries. With a techneque such as C3R it is down to the practitioners that wish to use this to go through the ethics side of things to show they are adequatly trained to perform this treatment. This is as much for their protection as ours.

Hope this makes it clearer.

As far as research funding goes I am unaware of any body that provides funding for the rresearch into our condition, it is all from a local source where a specialist has a particular interest. So someone in Australia is unlikely to get funding to resarch using British subjects in the study. This only occurs where medical universities do a colaberative study, but then each must find there own funding for the bit they are working on. With academia, getting any money for research is hard unless there is corperate sponsorship. This ahppens for contact lenses, but a sergical techneque brings very little commercial gain so there is no incentive for extra funding!

[jayuk]

Gareth

If something has CE then can it be used anywhere in Europe? Or is it still regionalised?...So thus UK would HAVE to get MHRA approval?

J

[GarethB]

Any equipment with a CE mark can be used anywhere in Europe.

The sticking point comes to training the practitioner. The the otherthing that comes to mind, once the equipment is installed it goes the Installation Qualification to ensure it is correctly installed. Operational Qualification to ensure it operates according to the manufacturers specifications and lastly Performance Qualification to ensure repeated use in normal operation is within pre set peramaters. This has to be to a minimum standard to pass any regulatory audit so should there be a complaint, then there is the appropriate documentation showing the instrument was working correctly, maintained correctly and used correctly and the practitioner had the appropriate training to use the equipment. Most will have a Satetement of Procedure which details how the treatment is done, and pre checks prior to uses etc. This is to ensure a consistent level of treatment is given.

I have to do this at work and left to work on a simple piece of equipment we have never had in the lab before will usually take 3 months to get through the system if everything works first time. It is not a case of me slapping a signature saying everything is OK, someone checks that I have done it properly and then a regulatory department ensure that everything would pass an audit buy such people as the FDA and MHRA.

All this documentation forms a legal document too which is why we are so careful before we put a signature to it.

Patients complain like hell about red tape, but if we failed to do this, they would be the first be sueing the pants off us for not ensuring correct instrument functions and adequate training was provided. So for all the compalints we get, it is for there benefit as much as ours.

[K Reading]

Thanks everyone for your comments.

I see there are people out there doing their best to find answers.

I don't know much about the scientific world and how much sharing of information goes on but
duplicated research is not a bad thing i guess if it increases the chances of proving the findings to be correct.

Thanks for the reasurances concerning passing this thing on to the children.

I used to work somewhere where there was lots of 'red tape' for good reason so I don't complain. ( well only in private and purely for theraputic reasons)

Thanks again
K