EBME Forums Forums Management Medical Equipment Management Risk-Centred Maintenance

The backup protection on this Risk Based system appears to be to "keep the managers informed" of deviations in your processes from those advised by the manufacturer.

Well try telling your manager you are not testing to the manufacturer's advised system and stand back & watch the blood drain from their face!

Have you ex-military blokes ever seen real naked terror? I have & it wasn't a combat situation. Nuf said?

Marc

As Geoff hinted, many service manuals do not recommend a service interval - only a method of service. Some manuals do not even give a service method. In these cases a reasoned judgement must be made as to how reliability and safety is achieved. Geoff's suggestion, based on empirical evidence, whether carried out by our colleagues across the water or by consensus with other professionals, seems to make good sense.

Rojo,

Whilst I can appreciate what you're getting at I do feel that it smacks of making up the rules as you go along because you and your peers can - with a defence based upon shaky precedents and a law of tort that's 70years old and crumbling. I read nothing about good-practice or exceeding the manufacturers recommendations - possibly cutting corners, for other motives, comes across to me. Do you have evidence that this line of defence works for cases involving maintenance that does not follow the explicit recommendations of the manufacturer given in service manuals and on training courses (read as written down, on paper)? Concerning your statement above:

It is difficult for me to imagine a scenario ocurring that if there were a serious problem, such as the death of an individual due to electrocution or failure to receive appropriate treatment, for example, and there was overwhelming evidence that the occurrance was found to be associated with some aspect of the maintenance methods employed (or not) that a non-technical layperson (read Judge) would necessarily conclude that:
Aren't manufacturers methods usually based on good practice? - since manufacturers are obliged to conform to standards of good practice aren't they (read Quality standards and GMP)?. This includes service literature and technical training doesn't it? Wouldn't the manufacturer of the device be obliged to produce evidence as the "expert" authority on the device? Wouldn't the manufacturer be obliged to protect the reputation of the company and the device by exposing any evidence of failure to follow maintenance guidelines?

Considering this; how much support from a manufacturer could the EBME "experts" expect if they did not follow recommendations and guidelines issued by the manufacturer? How would this look to a layperson (read as Judge or Jury)?

As I have said, the law of tort regarding the precedent established back in the 30's by the Bolam case has been superceded by other cases , conducted along similar lines, that the Judge (read as the man who makes the decision who's to blame) have found for the plaintiff - actually against the defendant and associated medical experts. Medical experts (read as bunch of Doctors who all have similar ideas that go against established methods) at that.

Richard,
Your argument is valid, but how do you decide how to maintain a device when the technical manual neither gives advice on planned maintenance or period?

Are there never times when we must make rational decisions based on knowledge of the device, recommendations, risk, resources etc.?

I qualified my statement - it was in response to this portion of Rojo's quote:

I disagree with this statement - it is negligent to make decisions that go against recommendations, guidelines and procedures when they are laid down in black and white.

John,

There is one thing for sure: there is a manufacturer for every medical device out there - devices that will, hopefully, have passed acceptance checks. Acceptance checks that involve a process that is supported by the relevant documentation i.e. a PPQ that requests information on equipment servicing, test equipment, operators manuals and options for servicing arrangements. This is so that informed decisions can be made at this stage in the life-cycle of an equipment type or model as to how best to maintain the equipment.

All equipment needs some form of maintenance despite some individuals' views on modern equipment never going faulty so if no service literature, advice or servicing information is forthcoming then perhaps the equipment should not be allowed into service or continue to be in service, for any appreciable time, without sourcing information from the manufacturer, vendor, agent or, in very rare circumstances, taking the risk assessment approach with advice from management and "experts" at the highest-level possible in the organisation.

However much NHS " Engineering Professionals" or "Experts" dislike it; the manufacturer is best placed to provide the relevant servicing literature and advice since they have the expertise and knowledge to manufacture, test and service the device. Medical equipment manufacturers are obliged to give the relevant information to competent individuals such as ourselves, so that we can perform maintenance at the convenience of our employer, to save money, or whatever - not to cut corners by ignoring what we think's appropriate to ignore.

There is not really an excuse for letting equipment out into use that has no servicing literature available for it, with no intention of following the manufacturers recommendations or to take measures that the manufacturer discourages. In my view it is ludicrous to insist, on one hand, that the information concerning servicing is provided by the manufacturer for a third party organisation to be able to service a medical device and then allow in-house NHS departments, such as ourselves, to apply our own methods of maintenance.

This attitude to servicing further encourages the "postcode lottery" in the standard and quality in servicing of equipment across the NHS - groups of individuals deciding to "go it alone" by making decisions that are not recommended and potentially flawed. It's the patients, staff and the reputations of the employer, manufacturer and engineer that will be compromised.

If this approach is applied logically then there is nothing to prevent any group of "expert" individuals, who may think themselves competent and above existing standards, guidelines, recommendations and standing instructions from their employers, from deciding to service anything that they fancy using any method they see fit. I wonder if some individuals have actually read MHRA, NHS, Manufacturers and all the other stuff that's out there and what CNST, Controls Assurance and Quality Standards are all about? Stuff and nonsense perhaps but guidelines and policy of our employer no-less; maybe it's better to use it where applicable than to make it up as we go along though.

John

You hit the nail on the head. I spend my time on this point, too often.

If it is not in the manual and also look at the PPQ, plus a little common engineering sense.

Hey Presto, don't buy it. But there you go, the companies tell me they sell them every where or is it any where?

Under NOF we are buying a Cath Lab, about £1million, Siemens, Philips, GE, Toshiba.

Includes Haemodynamics too. All of them have not provided maintenance schedules, not been asked for that before they say.

Circuit diagrams, competency based training. What are they?

Tu tu tu guys.

Live long and prosper, or die!

Jim,

Would you decide to make up your own test schedule for a CT scanner if you didn't have the manufacturers literature - even if you had worked on CT scanners before? I think not - if the information and training and skills were not available you would probably have to arrange servicing by the manufacturer or manufacturers agent (and you would probably ensure the agent were competent by getting assurances that they use manufacturers recommended parts and procedures). In this sense the manufacturers procedures are the "benchmark".

The examples you give are actually the exceptions to the rule because it is unlikely a small department like yours (or mine) can expect to perform in-house servicing on such devices without expensive training, test equipment and spares. We are only talking about equipment that we could service and associated servicing - it's the methods that we choose that are the issue; whether they're manufacturers or not. As I said - all equipment will need servicing at some time (unless it is a single-use disposable or suchlike).

You must arrange servicing for even the most complex equipment - the manuals are not absolutely necessary but some information is needed, on acceptance, to make the decision who services the equipment - even a man of your technical brilliance, Jim, cannot ignore the legislative requirements of ionising (and non-ionising) radiation regulations, etc, etc; so you would have to have servicing provided by some competent source. You would not decide to do it yourself in any fashion that you thought fit without referring to the manufacturer would you? Or would you?

How is your search for M3 manuals and service info from the manufacturer going by the way?

I'm all for consistency, good procurement and a quality life cycle approach to maintenance.
I think that where we use the same equipment for the same clinical use it should receive the same maintenance.

When we use the same equipment 10 times more than someone else it will require a shorter period before the planned maintenance is carried out, or 10 times less than someone else it will require a longer period.

That is why many manufacturers will often specify maintenance but not period.

I assess service contracts from manufacturers. On many of these contracts I am offered 'Return to base', 'Planned preventive', 'comprehensive' with 4, 2, or 1 service visit per annum.
Manufacturers offer alternatives because they recognise the needs of one Hospital may not be the needs of another. We need a quality approach and flexibility to develop the management of medical equipment based on local needs and sound engineering judgement.

We look after infusion pumps for TPN patients (in the community)that are used 84 hours a week. These receive a deeper level of servicing than pumps in the Hospital that are used 24 - 48 hours a week and where there is an equipment library providing approximately 15% redundancy, so if it does break down there is another one easily accessible.

Any manager must make decisions based on manufacturers service information, and STILL make a decision how to implement and use the service information provided. It is neccessary to consider risk, resources, period, reliability, as part of that decision making.

What if we all do it the same without looking at the whole picture? Does that mean we are doing it better?

I think collecting as much information as possible, from the manufacturer, is looking at as big a picture as you can when deciding how to service a specific item of equipment manufactured only by that specific manufacturer - remember I am talking about servicing methods - the hands-on servicing of a specific device (not generic) using a specific guideline or procedure laid down by the manufacturer. What I have commented on is that I don't agree, generally, with using methods that "go against" those recommended by the manufacturer, as Rojo put it, when they are laid-down explicitly.

Based on your experience in the RAF John, where you learned your trade, do the Technicians servicing ALARIS medical equipment in Cyprus do it differently from the technicians in the UK? No - they fly them over here to attend the service course, or fly the ALARIS trainer over there to do it. From Tornados to TENS units the RAF does it consistently and they won't do it without following the manufacturers recommendations or using manufacturers recommended parts. Why do they do this - is it not a valid method in the NHS?

So RAF technicians are all trained to the same standard and employ consistent methods. £10,000 in one year for an RAF Technician on product training was the last figure from the RAF technician that received it, I was informed by him when I was on a course with him, for different medical and dental product training courses. The RAF doesn't generally work on it unless the technicians been trained on it. Of course, I am using this example to look at the "bigger picture" as you put it. Surely there is lowest risk when you follow established recommendations from the manufacturer.