EBME Forums Forums Management Medical Equipment Management The future of ebme

Hello Geoff et Al

I consider that my view is in the minority - and as you proposed Geoff - It may be an idea for me to get back on the tools for a couple of days - back to the trenches... I don't remember it being all that bad.

I may be in the minority, but if a company makes a medical device and have said it is maintenance free with a life of 5 years - what maintenance would you carry out?

An internal defibrillator is not maintained - so why maintain an AED if the company says it is maintenance free?

It seems that my previous comment about 'maintenance free' insulin delivery infusion pumps has caused some concern. Here is another fact that caused us a bit of a problem some time ago.

We were initially told by the company that supplies the Paradigm pump that no EME type acceptance test of the device was required. The Trust specialist nurse obviously does her own checks prior to issue to the patient after receiving training by the company. At this stage my concerns were obviously that 'it does what it says on the tin'. (in the manual in this case).

I remember having friendly conference calls with the lab in the US that manufacture the device, and their comment to me was "nobody has asked us for an acceptance test procedure before". Consequently we developed one ourselves.

We were then told that we didn't need to do it this (our) way. The company later sent us an acceptance procedure that they had then written addressing our concerns. This is the one that we now use.

The pumps have been in use in the community for nearly a year and we havn't been informed of any problems. The device has obvious benefits to the patient and my own opinion is that it is a good device.

What concerns me is that they had told me previously that there were other Trusts in the UK that were using this device. Have they performed an acceptance test on these devices? Are they aware that they are maintenance free? Worrying indeed.

Can a manufacturing company legally declare medical equipment maintenance free, when regulations are in place for preventive maintenance ?? and heaven forbid that a 'maintenance free' piece of kit fail and cause injury or death to a patient who will take the blame, the end-user, BME or the manufacturer.

Doesn't maintenance free just mean there are no replacement service kits to fit etc. Surely the machine will still need a verification check every year or so.

I don't think we will ever get to the stage where a medical device or any other equipment can be catagorised as "all that is perfect"

It brings me to doubt if fault codes are a revolutionary aid to fault finding....what the manufacturers actually mean is " we know of certain design flaws and problems which arise which over the years we havn't really done anything about".... real fault finding is when the device malfunctions and there is no associated fault code with the problem.

Remember most of all .... The Titanic was designed to be unsinkable

John asks
"so why maintain an AED if the company says it is maintenance free?"
We have a lot of AED's here and although supposed to be maintenance free there are monthly checks that the staff should be performing - all very simple checks but not always performed as these are logged in the defib. So at the minimum we download the history and retain, physical inspection and check the battery capacity remaining and change as necessary. We have also found pads out of date, incorrect pads. So yes there is equipment supposed to be mainenance free but it still nedds us to check them for the obvious.

I see what you're saying Graham.

Just because it is maintenance free doesn't mean that it shouldn't be properly inspected on a regular basis.

So what qualifications are required to carry out an inspection? Could we have a technical assistant inspecting maintenance free defibs?

as Nursing assistants check general observations?

Do we need to review the future skill mix?

Qualified technicians are hard to find - technician assistants may be part of the solution.

An ideal task for an apprentice to undertake

I realise that you're fishing for ideas, John, but you can't have it both ways, Mate. One day we're hearing that everyone needs to have a degree and get themselves on registers, and now we're hearing that biomed needs to be dumbed down.

If there is indeed a dearth of good techs in the NHS, let the government get the situation sorted out. See the current thread about "Apprenticeships"!

John, do you have a list of the items that you will talk about regarding the future of EBME as the discussion seemed to be going down one track and that was 'maintenance free' if there are topics that need individual inputs then lets see what you consider as priorities, for me the future lies with planning, tendering and design work, working closer with the consultants and adminstrators, especially in the area of purchasing as this should not be done by an accountant who tries to save a pound here and a pound there, cheaper in the short term does not equal cheaper in the long run. After sales service must always be considered.