EBME Forums Forums Management Professional Issues Biomedical accreditation

Just found an old email from the MHRA with their classic disclaimer statement

Please note that whilst we are willing to give any help and advice we can,
any views given by us on the interpretation of the Medical Device
Regulations represent our best judgement at the time, based on the
information available. Such views are not meant to be definitive statements
of the law, which may only be given by the Courts. Accordingly, we would
always advise enquirers to seek the views of their own professional
advisors.

I hope this has been of some assistance to answer your questions.

Yours Sincerely

Tore Johansen
Regulatory Affairs Manager

Manufacturers instructions can almost always be improved upon, especially on new equipment. The instructions are most often written in the factory by people who have little idea of how life operates in real life in hospitals. In my experience the the instructions are written in a very short time just to put something down with very little input from the field. The instructions are very rarely changed after the equipment has been in use for some time even though a lot is often learnt in the first couple of years of a new piece of equipment's life.
However the crunch is if it ever came to a court then ironically the first question to be asked would be "Was the equipment serviced as per the manufacturer's instructions?"
Life is sometimes unfair.

Denis.

If the manufacturer’s instructions have to be followed “by law” (something, by the way, that I personally do not accept), in cases where they are rubbish, surely they should be challenged? As John keeps reminding us – be Proactive!

I agree Geoff, but who will be the first to tread this unchartered legal path. Not me I hope!

How come maunfacturers parts have to be replaced at such convenient intervals. Do they make things to last exactly 6 months or do they do risk assessments and it so hapens that things seem to fail after 6 months.
Do electrical appliances have special insulation in them that breaks down if it is not tested every year?
I might be cynical in suspecting manufacturers instruction writers just make up convenient time intervals and it is not done by a rigorous method of testing, evaluation and risk analysis.

I think I am getting in to the discussion I said I did not want to start. Sorry.

Robert

How come maunfacturers parts have to be replaced at such convenient intervals. Do they make things to last exactly 6 months or do they do risk assessments and it so hapens that things seem to fail after 6 months.
Do electrical appliances have special insulation in them that breaks down if it is not tested every year?
I might be cynical in suspecting manufacturers instruction writers just make up convenient time intervals and it is not done by a rigorous method of testing, evaluation and risk analysis.

I think I am getting in to the discussion I said I did not want to start. Sorry.

Hareesh
Are you really saying the suppliers of equipment will not provide you with a manual? If this is so should you look in to alternative equipment and suppliers? Surely the ability to do the correct maintenance must be a factor in choosing equipment.
Or is this the reason for your initial posting?
Robert

Robert

Er, how can I put this, Robert – you obviously have never worked in what we used to call the Middle East. Let’s just say that different rules apply!

I am afraid I have just been in the NHS where we make reasoned decissions based on many factors and then buy the one the consultant likes.
Robert

Rojo, That is exactly what manufacter's do do, make up many of the checks and procedures. Normally design engineers make a damn good job of designing the equipment and when completed pass the project on to the factory technical support guy. The technical support guy together with technical author produce a service manual, often a very good one with far too much circuit information that will never be needed. Then because the boss has said he must the tech support guy (often someone with no experience of life in the field)writes procedures for PMs. This is where it is a case of putting finger in the air and making things up, because at this part of the equipment cycle nobody really knows what needs to be done on a routine basis. In fact with most devices nowadays nothing really needs to be done at all anyway!!!!
The first year of a product is a learning experience for all concerned as warts often show and design changes are often made to the equipment, but the PM procedures are rarely adjusted or changed as this on a priority level is seen as very low.

Geoff,
Nobody has ever said that manufacturer's instructions have to be followed by law. However in the event of a death or serious injury I do think it would be advantageous to stand up in a court of law and prove that all manufacturers procedures were followed, regardless of whether these procedures were relevant or not.