I am planning to have accrediation for the biomeical department acitivities in my hospital.ECRI is seems to be very expensive,can any one advice me for any other alternative sources?

What about JCIA? I am not sure how much it costs for accreditation, but it could be an alternate source.

hello, you might want to find out what goerning bodeis within the country you work in are allowed to certify you. i assume you are talking about iso:9001:2000?

No,I am not looking for certification.Looking for the bodies who will provide the standards to be followed for biomedical activities like checklist for all equipments to perform PMs.Procedure for new equipment procurement,BM procedures and other core functions of the inhouse biomedical.

Hareesh,
If, for starters, you follow the manufacturers recommendations in the manual you cannot be wrong, you do not need an outside body to accredit you.
There then comes the issue that has been often discussed here as to whether one carries on doing this or modifies it. I do not intend to start that debate up again you can read it for yourself in various topics on this forum.

But in essence what people do is to modify the manufacturers procedures in light of the own knowledge and experience, gained from similar devices or from the devices in question over time. They then document the changes they are making and most importantly the reasons behind them. This process needs to be under constant review and preferably reviewed by others in the same field. i.e. get together a team from several hospitals and discuss this and come to a consensus of opinion.

An example:
The manual says change a part every three months, if you see no wear on it you decide to change it every six months, if you still see no increase in the rate of failure you might consider increasing this time scale some more. If however the failure rate goes up you decrease the time between replacements. This results in the minimum of work for no increase in failure or compromise in safety.
This holds true for routine testing as well, if you are testing something and find no faults and need to do no alterations you can increase the time between tests. But as soon as you see things out of tolerance and you need to do remedial work you have gone too far and have to do more frequent testing. Again you are increasing time to the maximum before you start seeing an effect on the equipment and then backing off.

There is no body that will tell you that you are absolutely right or wrong in what you are doing for each item of equipment, only the manufacturers provide service recommendations. Some people say they tell you to do too much testing and replace parts too frequently so they can sell them to you. I am not going to get in to the areguement whether these people are right or unsafe.
Whether you follow the manufacturers or decide to start from their recommendations and modify them using risk analysis is a decission only you can make. Do you need an outside body to do this? I think not.

I do not know the situation in your country and whether insurance and legal liability will have some effect on what you are doing and how you modify it. You will have to take this in to account as well. This is the debate that has been argued many times on this forum. Whether we have the right to modify the manufacturers procedures. But which ever view one takes it all starts from the manufacturers procedures. And if you take that as your starting point you have your external accreditation. "I am doing what this company says needs to be done to its product."

I hope this helps
Regards
Robert

If you're into Risk-Centred Maintenance, then perhaps you missed this one, Hareesh:-

http://www.ebme.co.uk/ubb/ultimatebb.php/topic/9/197.html

Hareesh, I reckon your safest route to accreditation is via ECRI and HECS thereby getting JCAHO accreditation, from our good ole
"Colonial Cousins across the Pond " who seem to have your Neck of the Woods pretty sewn up
Hows the Weather ?? Must be nice out there now, Looking forward to the Summer I bet
Take Care Tony.

Unless Hareesh would like you and me to spend the summer out there writing up his procedures and sorting out his stores, eh Tony? How about it, then, Hareesh (better reply by private message, though)?

Thanks a lot for all feedbacks.As Robert mentioned first preference has to be given to the manufacturer's recommendation because they know better about their product than any one.This part of the world not all the suppliers will provide the service manual,those cases it will be a problem.Ofcource we can prepare a common check list for all or procedures but it will be better if we follow some thing which is traceable to international standards.

I am happy to invite all here to enjoy the summer ,probably that kind of climate you may not get any where else!!!!

Hareeh

It is often debated whether manufacturers carryout risk assessments or just decide on a nominal year/half yearly PPM. I suspect in most cases it is the latter. This is where Reliability Centred Maintenance can have a part.

However in the EU we must maintain the equipment in accordance with Manufacturers guidance even if we think the schedules are overkill.

The scenario I have used in the past is that in the event of an incident reaching a coroner or court the MHRA will be called to give evidence. They wil state that the device should be serviced in strict accordance with maunfacturers guidance. The manufacturer will take to the stand and say that his kit must be serviced every 6 months. We will then take the stand and have to argue that our yearly policy was adequate and that the 6 months suggested by the manufacturer was too much.

The coroner/jury are lay people and probably not technically competent. What would stick in their minds is that the Government said follow what the manufacturer states, the manufacturer states do A and the EBME engineer does B.

To add insult to injury the MHRA will continue to sit on the fence until a presedence is set a court case. Who has received an annoying letter from the MHRA saying that this is the advance but we should consult our own lawyers and only the courts can give a definative view. Basically this is our advice but it isn't really speak to your lawyers but then again they can't advise you only the courts can.