EBME Forums Forums Management Medical Equipment Management Reliability centred maintenance

KM,
I make decisions every day regarding the management of medical devices. I involve people in the decision making where I feel necessary. As far as authority with regard to Medical Equipment Management, yes I can make these decisions. It Trust Policy that issues involving management of Medical Equipment come through EBME, and also the EBME User group. Any decisions of this nature are recorded as part of our management reviews and quality audits. We have also raised a concession note which will stand until we have evidence to show that it has not affected reliability.

Can I ask you guys a question, how relevant do you think the service intervals are as stated by the manufacturer? Why do they publish their recommendations, is there an element of financial gain, or are the R&D bods responsible for the decision on a purely safety aspect. John I feel that you are disrespecting the importance of the manufacturers advice.

Seymour

John
I believe the way forward is as you suggest. As equipment becomes more reliable there has to be a review of the maintenance periodicity. This will ensure it is safe to use but also cost effective. The way this is achieved is open to argument as we all have different views on what is required. The way forward, in my humble opinion, is to utilise maintenance data to optimise a maintenance management program. In addition, couple that to a risk based strategy that reviews where and how the equipment is used. What the consequences of your actions would be and ensure that you have evidence to justify any decision is made. I believe manufacturers have a vested interest in their decisions on maintenance times, therefore they have to be considered but providing your evidence can demonstrate there is no detriment to the equipment I see no reason for not making that judgement. Surely that is why we are here

Margeret, aka Seymour,
No disrespect to the manufacturer intended. If you visit any large manufacturer and look at the way they carry out maintenance you may well find they use RCM.

I have gone down this road because equipment is becoming more reliable and it is not reflected in the 'recommended' service intervals given by many manufacturers. They can only recommend service intervals. We still have a decision to make. Do we service at that interval, decrease the interval, increase the interval, or wait for failure. In my experience, most EBME depts use all of these options, especially the 'wait for failure' option. (Due to poor resourcing)

It is better to concentrate your service effort on the high risk devices, reduce the service period on medium risk, and wait for failure on low risk.

John, I agree, but does it not require some global standardization. Again I can’t help but wonder what the MDA (or whatever flag they fly these days) are there for??? No disrespect but they seem to bury their heads on these types of issues. To alter the service schedule without official representation could be deemed as negligent. Surely it has to be a global decision with official backing.

Seymour

John

You may recall a similar discussion re the MHRA gas regulators notice, I believe the same applies with manufacturers recommended PPM interval. My original comments were

"If you look at the notice under the Problem section it quotes that MHRA have received reports of leaks, inaccuracy and ignition from poorly maintained regulators or flowmeters. If a patient was to die from said device which was not properly maintained then the first thing the coroner would ask is if we followed the MHRA guidance as the risk was known.

I have spoken with MHRA at depth regarding previous notices and everything seems to be if we follow manufacturers advice then we would have nothing to worry about. Therefore if for example Therapy say just carryout functional test then that should satisfy any coroner or court. However this means that we would have to follow DO advice on two PPM a year.

The scenario would be if we were called to a coroners inquest to give evidence.

The coroner would ask "How frequently was the flowmeter serviced?"

If it was any less than what the manufacturer advices the Trust would be sued, remember that the family and possibly their lawyers would be at the inquest. What would stick in their mind is the Trust did not follow manufacturers APPROVED guidelines.

Food for thought!!! "

I had a chat with our legal advisor yesterday and he was horrified that a Trust would consider lengthening a manufacturers PPM interval. If an incident occurred and the patient complained the Trust would be legally liable to settle as the courts would latch on to the fact that we knowingling maintained a device below the spec required by the manufacturer. However he did say that we could stick to the manufacturers recommended PPM interval and heaven forbid if anything happened we could claim that we just didn't have the resources to perform the maintenance as agreed, which would be true.

What I am trying to say don't expose yourself John or your Trust by moving away from Manufacturers guidance, you can be sure if the S@#t hits the fan both the manufacturer and MHRA will drop you in it. Our legal advisers have discussed this in the past with MHRA and their stance is what ever the manufacturer says goes, the manufacturer has carried out the R & D and pre clinical testing to determine the service interval. MHRA and more importantly Trusts do not have access to this information to make a decision on PPM service intervals, we would not be able to defend our risk assessments in court. Can you safely say that you could John.

Just to add further doom and gloom, if a device malfunctioned and the patient died and the courts found out the service interval had been deliberatley increased. We have been advised that the individual who made that decision could theoretically be charged with manslaughter!!! This I feel puts it all into perspective

I hope this helps

John

Bioman, as we have come to respect, has clearly highlighted the blunt reality of what we all dread.

“What the scenario would be if we were called to a coroners inquest to give evidence.”

The reasoning behind my previous suggestion:-

“I suggest the introduction of equipment libraries, where the majority of the hospital's medical equipment is routinely visually inspected be skilled or semiskilled staff, would strengthen your case for rationalised maintenance schedules.”

was that a frequent/routine quality inspection by a skilled/semiskilled MTO was a superior ppm maintenance schedule. e.g. The manufacturer recommends a six monthly ppm check on an infusion pump. We provide one annual ppm check and 6 to 24 quality visual inspections.

Bill

I THINK BIOMAN HAS GOT IT RIGHT, THIS IS WHAT I WAS SUGGESTING SHOULD / COULD HAPPEN.

The Lads are right John. Don,t forget it is YOU who will face " M,Lud and M,Learned Friend " We live in a Litigious Society now. Remember the old Ex-Pat maxims CYA at all times.
( Cover Your Ar** ) Take care Tone.

I am about to put the cat amoungst the pigeons.
What happened to evidence based medicine? I thought that it was all the rage? You investigated a situation, tested actions for the best outcome, analysed your results and then implemented best procedure.
And risk assessment of a situation is also "in". You weigh up the pros and cons of a situation analyse the results, document your decision and do what is best and achievable.
Does this not also apply to us?

I know that we live in a more litigious society and that the supporting rug will be pulled from under us when the fan starts to turn brown, but surely if we make a decission based on our "professional judgement" (and can prove the process through documentation) we are not neglegent.
Neglegence is ignoring a situation, surely you are not neglegent if you are analysing it and tackling it with your reasoned best effort.
Will we be taken to court or our employer? I thought the chief exec took ultimate responsibility. It is his responsibility to employ competant people and to check they do the work correctly.

This is full of questions as I do not know the correct answers. I am just hoping to stimulate debate by putting a different point of view that I feel carries some weight.

Robert

P.S. Are these people hiding behind pseudonyms just company engineers trying to get us to do more maintenance to sell more over priced spares? JOKE. Anyway this is for another topic.