EBME Forums Forums Management Medical Equipment Management Risk Assessment of Medical Equipment

Here I am again!

I am looking at developing risk assessments for establishing whether equipment falls under the High, Medium or Low risk equipment. Has anyone got a board outline of the types of assessments they use so that I can have an idea of where to start?

Thanks for all the information people sent me regarding competency training it was very useful.

Mandy, may Louis bid you an ostentatiously delightful day... Regarding your question, this subject was debated "inconclusively" a few months back in this very forum, you can start here. Louis thinks the manufacturer/Vendor should provide this "classification".

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Kind Regards
Louis III

Louis

Thank you very much

There is a problem with this ! There are situations where a "low" risk piece of equipment (such as an electrical suction machine, for instance, although some people class this as "medium" !) may actually pose a "high" risk because of either the location it is being used in, or the patient it is being used on.

We had a case where a suction machine refused to suck because the hydrophobic filter was dirty. The patient had a very severe chest problem - but also a fairly serious heart problem. He was being nursed in a side ward where there was no piped vacuum, so when they needed to suck him out and couldn't, he nearly died of a heart attack brought on by the fact he couldn't breathe !

I'm sure there are lots of similar examples - which make it difficult to classify what appear to be quite straight forward items. So far we've only decided on the "high" risk category - such things as anaesthetic machines and patient ventilators - which seem to be fairly obvious. Where to put the other items is the subject of ongoing discussions !

Hi Mandy,
Risk assesment of medical equipment can be carried out in various ways, you have to make a judgement based on experience and equipment history.
One method uses the likelihood of a given piece of equipment breaking down and causing physical harm in its broken stae. The device is given a ppm priority based on device's risk level which is based on the following analysis.

1) A device's likelihood of breaking down.
2) The chance of the device's faulty state being noticed by a non-technical person.
3) The chance of the device causing serious injury in defective state.
You can assign a risk number to every device type in your care on a scale of 1, for lowest risk, to 9, for the greatest risk for each category: likelihood of breaking down, likelihood of causing injury and likelihood of the break down being noticed. These figure can then be used to guide you and if you want to get more technical you can use the following formula:
RP(Relative Probability of breakdown * (RP of for serious injury ) divided by the (RP of the Breakdown being noticed ) = Severity Score
Risk Levels:
A Score over 27 HIGH RISK
B Score between 19 to 27 MEDIUM/HIGH
C Score between 10 to 18 MODERATE RISK
Score below 9 LOW RISK
The above is based on the model detailed by Ethan Hertz, published in Biomedical Instrumentation & Technology.

If anyonwes feeling generous I would appreciate a copy of any assessments that they have just to see if ours are at a simular level.Cheers

We have scored our Medical Devices as either High, Medium or Low risk to enable us to prioritise device training. To do so we used a "risk matrix" - this scores the likelihood of risk against the consequence of the risk.

Before this can be employed certain asumptions have to be made i.e.
- that the device is safe to use (not faulty)
- that the user knows why they are using the device
- that the user has not received training to use the device

This helps to achieve an objective (& repeatable)opinion on the the risk score to be reached.

The "risk matrix" was based on a standard tool but tweaked slightly to make it work for individual medical devices - yes, originally we were told to use our Trust's standard tool that was being developed, but after consulting our H&S people they agreed to modify their tool along the lines of our tool. The reason for this being that a single medical device could cause a death, but still not be considered a high risk in the big scheme of things!

Some of this risk matrix developed from ideas from various sources including various medical device trainers & their input is acknowledged.

Anyone who would like to see the Risk Tool & a table of scores reached for various Devices can contact me.

Mark

I agree with Ron. Louis too would love to cast his mincers over the various "scoring systems" that are in place in there respective trusts. Paul Horn sent me an excellent document a few months back. But it still remains a very grey area indeed. Another chance for the EBME "Dons" around your country to draw up a standard with the MDA.. Hmm interesting to see if it is regarded as a problem with a workable solution, or in the usual managerial jobs worth style, "Not our responsibilty" .. Your move Managers. :p An ideal solution would be to have the correct amount of staff to cover all the work in the first instants and thus remove all risk. Yes I know, cost, shortage of qualified staff, "Huston, you have a problem" you also have a duty to the "tax payer". Good luck
Louis III

Ah, risk--an issue close to my heart, and an interesting conversation. I'd like to put in my 2 cents. "low" risk piece of equipment may actually pose a "high" risk." Agree totally, which is why I like, "The chance of the device's faulty state being noticed by a non-technical person" as a risk characteristic, while "A device's likelihood of breaking down" I've found unreliable as an indicator--assuming the device is not new. We've used 4 weighted criteria plus 1 additional: does the device have 100% electronic self test?, will failure be apparent to user?, does device require cal, lube, or part?, is consequence of failure great?, and 5, have defects been found during inspections that users missed (how effective maintenance is)? There ARE some elaborate formulas, but often they rely on more arbitrary input than they're worth.

Louis has had a chance to sleep and in doing so has come up with the following theory.

Imagine if the manufacturer of these medical devices provided us with their recommendations on the correct service procedures and service intervals for the kit in question. They could place instruction in a book, they could call this book a service manual. Its fantastically ostentatiously simple.

We as departments could then use these new technical bibles to help determine our annual PPM work load. We could then either invite the manufacturer to do this work for us, alternatively, we could undergo this work ourselves. We could employ technicians who may be on hand day and night to give our little intemperance’s who work so unassumingly in the Icu’s, Ward, ER’s, Theatres etc. technical guidance as and when they require it.
We could then employ managers to drop tons of manure on top of these technical wizards and stop them in their very tracks. Place them into labyrinths filled with bureaucratic waffle and see how much red tape needs to be unreeled before these once dedicated fine soldiers of the NHS crumble into bitterly neglected limpets. But alas my friends, this is Cool Britannia, could never happen in a million years.

Louis III