EBME Forums Forums Management Medical Equipment Management Life cycle of an infusion device

I am writing a chapter in a book on infusion therapy and I am covering the devices chapter. I am at the section which considers when a device needs to be replaced.

does anyone have a current reference (within the last 6 years) that I could use.

Much appreciated

Chris

Hello Chris

We use 7 yrs as the replacement planning time for infusion pumps. I do not have a reference, but this is the standard that most EBME depts use for electronic devices (except ultrasound which is 5 yrs). The components, especially capacitors, deteriorate, and the component failure in electronic equipment normally occurs in the first year (First year can normally be attributed to manufacturing type faults) or at at the 7 to 10 Yr point (7 to 10 yr is normally component failure / deterioration). I did see a reseach paper on this many years ago, but i can't find it. If it turns up in my piles of paper i will send you a copy.
John.

Maybe we should have a debate on equipment life and set down some downloadable recommendations...

Chris

The main general advice on medical device replacement is still MDA publication DB9801 "Medical Device and Equipment Management for Hospital and Community Based Organisations" (nice short name)
That's undergoing a substantial re-write. The current copy available from the MHRA online has advice (what little there is) on page H12.

The other one I think you probably already know is publication
DB2003(02) "Infusion Systems"
with its even tinier bit of advice on page 49.

Our trust insisted many years ago on eking out a full 10 years for our medical devices. The lifespan expected varies between trusts with no accepted general figure.
It generally depends upon simply seeing how the equipment continues to perform.

Naturally set costs are becoming a significant driver in replacement. Forthcoming legislation requiring anti free-flow devices to be included in infusion sets will also force a lot of replacements though that's likely to make sets more expensive.

Safety software ought to be an issue I suppose but we are still catching up on standardising, training, keeping it clean and reporting it when it's had a hammering. Best get that right first.

All the best

Marc

Chris,
I thought you worked for an infusion device manufacturer, do they give any guidance as to the life expectancy of their equipment. I realise that there is a difference between mechanical life, which given a source of spare parts is theoretically infinite, and usable life when the technology, expectations and requirements become out dated.
I would have thought that a manufacturer would have a life cycle plan so that the new model came out just as people were ready to get rid of the old ones.
Robert

It would probably be a very good idea to come up with some sensible life for medical equipment. I have only ever seen a recommendation from the the Royal College of Obs and Gynae relating to a recommended 5 year life of ultrasound. Maybe between us all, we could produce a table of appropriate life spans either based on papers done previously or the common sense approach.

In a previous existence I was Engineering Support Manager for a laboratory instrumentation manufacturer (mainly Biochemistry/Path Labs). We investigated this topic after being asked by one of the hospitals that we supplied equipment to. We concluded that it was impossible to give an acurate life expectancy for our products due to so many variables in the workplace (incorrect use, clumsy operatives,lack of service, environment etc). All we would commit to was support for any equipment for a minimum of seven years from date of last manufacture. The main reason if I remember rightly was for legal liability "You said your XYZ would last for ten years and it has only lasted eight"!

Dear all,
Thanks for taking the time to respond. I think without exception nearly everyone I have spoken to states 7 to 10 years as the commonly understood lifecycle timeframes. I did speak to one of my technical/ regulatory colleagues at work (Alaris) and the only thing that he said was that the EU Medical Devices Directive requires the manufacturers to state how long their device(s) are expected to last. What most say is that there is a committment to supply spares/ parts etc for a device for (MIN) 7 years. It seems that there is no definitive life span BUT most of what you guys have said above would indicate to me that with wear and tear etc it could be cost effective to replace between 7-10 years. What I would think, mindful of your responses above, devices older than 10 years should be considered for replacement. I would like to finally add that the work I carried out at NPSA found that in the 6 pilot trusts we looked at, on average 20% of stock was older than 10years old: with much of this stock between 15 - 20 years old and still in circulation (but ??fit for purpose??). Therefore, it is my view that this lifecycle issue is somewhat wooly and if only to clarify, further debate needed.

Best wishes

Chris

I am also interested in the "expected life" of equipment and through experience and observation believe a rigid replacement programme is not necessarily the only way forward.

To qualify this, a medical device will usually be condemned via one of the following means, clinically obsolete (via the user/MHRA), technically obsolete (i.e. via manufacturer), technically retired on the grounds of ill health (unreliable), or redundant (the clinical need no longer exists).

There are also the capital charges that apply for equipment costing £5k or more. Certainly in our Trust after 7 years most equipment is considered as having zero capital value and is reviewed and considered for replacement, (some exceptions to this would be in Radiology where I believe a 10 to 15 year rating is applied).

At 7 years providing it meets the clinical need, is reliable and fully supported by the manufacturer then the automatic replacement need not apply.

In the case of infusion therapy there are the technical advances and introduction of safety features that prompt change also.

Your thoughts?

Regards

Mark