Hi All

As part of our contract we are required to perform EST to patient beds. We have to test the beds with the patients in them !!

Just wanted to hear other peoples views from a H&S point of view of how a EST to a patient bed should take place.

Do you have a policy ?

... yes; I wouldn't do it.

Other than that, what do your company's lawyers (and insurance brokers) have to say about it?

And lastly, when you say EST ... which specific tests do you mean? Protective earth continuity only?

Hi Geoff

We are performing full EST, earth continuity, Insulation resistance, earth leakage and touch current.

Clearly there is a potential hazard to the patient if you perform these tests while the patient is still residing in it! In the case of the earth leakage test the protective earth will be broken during the test and potentially exposes the patient to a electric shock risk.

I assume you are using IEC 62353, which states:

Clearly you are failing in this duty of care when you test while the patient is still connected to the medical device!

Primum non nocere!

We ask the patients who are able to vacate the bed say for their physio or to move around. This is agreed prior and entered to the patient and ward notes and if needed clinical staff are paid for to manage the time out of the bed. If the patient is bed bound then arrangements upon turning the patient incorporates a bed change to substitute the good from bad. In no way do we compromise patient care,safety or excessive sheer issues.
I can send a policy of extract to support this as needed.
Paul

I'm wondering what the urgency is in this situation; something contractual, perhaps?

But what does the Risk Assessment say?

Do such beds ever fail an EST? And what happens (ie, to the returning patient) if they do?

Why not just wait until the nursing staff let you know when a bed finally becomes free, and then go along and EST (and PM) it?

We have a very small team for a 600+ bed hospital and it is quite had to do with our PM's to complete and approx 350 breakdowns a month.....

Yes, there are only so many hours in a day (working week, whatever).

It sounds like you need to adopt that time-honoured biomeds' approach to the work of tackling tasks in order of priority.

Setting up a Risk-Based PM programme might be a good place to start (regardless of what contracts might "require").

When you assign Risk Levels to the various equipment types you look after, you may well find that carrying out routine electrical safety tests on patient beds comes way down the list (and therefore will probably never get done). I would suggest, "Repair when failed" might be a good maintenance support policy for run-of-the-mill patient beds.

I would reiterate what Geoff has said above, risk management is the way forward.
By the way, are the beds class I or class II??
We have a similar albeit smaller problem within two hospices in a service contract,frequently we part from our central office with a blue light when the beds become vacant :-((

Malcolm.

Geoff....do we read between the lines"We have a very small team" that they are looking for new recruits....Australia is on my bucket list,what about you....

Yes, I like to think I'm pretty good at "reading between the lines".

I have yet to come across any biomed team anywhere that I would describe as "over-manned".

That's why I keep banging on about the need (obvious, I would have thought) to prioritize the work.

Even "back in my day" (and often with myself and my gang "busting a gut", you might say), there were often times when we were way behind in what we were "supposed" to be doing - and, yes, sometimes stuff went "un-done". But, as far as I remember, nothing catastrophic resulted from our (my) management of the situation(s).

On your last point - if I were thirty (forty?) years younger:- yes, by all means. I can't see much future for any keen young guy (not me, then) here in the UK. Anytime I meet a "fertile young mind" I always advise him (and it generally is a him) accordingly.

We are never aloud to EST a bed with a patient in it, that's crazy! When ours are done if a patient is too ill to get out of bed, the bed is logged and tagged to be done when available!

OK ... just to continue (prolong?) the debate here:-

1) What EST(s) do you carry out on beds?
2) Which Standard do you follow?
3) How often do you carry them out?
4) How many have "failed" (if any)?
5) Do you do these EST(s) as part of PM?
6) How are beds that "fail" EST(s) (or PM) dealt with?

Sorry I haven't been on for a while

I have won Beds are now pulled out of service for PM's by engineering and then EST'd by biomed before returning

Hi Geoff, I give support to two 50 bed Hospice's here in Rome, as the is no fixed technical presence I give support on a ad hoc basis for repairs and a programmed visit for the PM/EST, as sure as the Pope is a catholic during my PM visit there is almost always 100% bed occupancy.
In one of the locations the mains supply is 220v split phase, end result the Fluke ESA612 reports a no reference earth message, I have therefore decided ( with the consent of the person responsible for the QC) to use use the alternative method of the EN 62353 for the EST's.
I'm "obliged" to perform the EST, where possible, on beds with patients, as this method isolates the DUT from the mains supply and is current limited, this to me is the safest method available apart from not carrying out the EST until the bed is empty. As both structures have a waiting list with a turn around bed occupancy of approximately 12 hours I can't see the alternative solution (open to suggestions....)
Rare failures are always earth bond centered which result in the programmed replacement of the mains cable.

It sounds like you're doing the best you can there, Malcolm.

As you know, the Alternative Method does not activate the DUT, and so therefore is not comparable to all 60601 tests (especially leakage currents) ... however, for occupied beds and similar items I should imagine it's more or less ideal!

And ... I'm guessing that where you are, mains polarity is not an issue (ie, can be either way around).

I have encountered the "split phase" situation myself in strange locations many moons ago; our tester didn't pass it's Self Test!

But (more importantly), how good is the building earth in the places you mention?

Lastly, are those mains cables fixed, or detachable, I wonder?

Fortunately the building earth is very good.The beds are all Hill-Rom with fixed mains.

The Alternative method will give you the same result as a open neutral 60601-1 test, so is comparable.

Using the Alternative method offers a massive time saving over all other methods, since you don’t need to reverse the polarity of the mains and you don’t have to wait for systems to boot up and down between tests. It also is safer for both the tester and those in the vicinity of the EUT. No need for insulation tests if you suspect an insulation problem, such as liquid ingress.

This is the reason many equipment manufacturers are switching to using IEC 62353 and the Alternative method. My experience is that very little equipment is unsuitable for the Alternative method.

Just out of interest ... I understand (?) that the Alternative Method issues predictive leakage current results.

Does anyone know how (or even better, actually tested) these leakage currents compare with actual values measured using either the Direct Method or traditional 60601 tests?

In other words, how accurate are these predictions?

See here.

..what the use of test instrument by the way?

Healthcare institutes must be single phase, dual phase was, and still is the lazy way to upgrade from 110V to 220V

Eh? What about 3-phase (for x-ray systems, etc.)?

I think what you meant to say there, Neil, was that (in some locations) both 110 and 220 VAC may be taken from a supply transformer in star configuration!

But (and perhaps more importantly in such cases) where is the earth connected?

I have always thought that "two-phase power supplies" was an "American idea". I have only ever encountered them in buildings built to "domestic standards" in places like Saudi Arabia (village clinics, and the like). Only once did I come across a piece of "medical equipment" that actually required a 220 VAC two-phase supply in a proper hospital, and that was an ancient baby milk-bottles sterilizer (I think it was) made in the USA.

Do you mean the 62353 Alternative Method?

For more, see this earlier thread.

You will need an Safety Tester that can accommodate this (has this "feature").

Going back with the initial queries. In our policy in Malaysia, when we performing PPM inclusive with EST for any medical equipment regardless class 1 or class 2, it shall be isolated from patient. This shall minimize any potential risk exposed to the patient which will lead into severe damage.

OK, that's the policy. But how do you implement the policy in cases where beds are hardly ever (if at all) vacated?

Are you following 62353 ... and especially, the Alternative Method?

We never experienced that.

Normally bed, the frequency for the PPM is once a year and bed hardly vacated is normally in ICU.

We still emphasize in 60601 and not yet 62353.

For ICU, ask the head nurse to inform BME when the room becomes vacant, death, theatre procedure or any other service outside of the ICU and PPM all the equipment for that room.

1) Patient goes to Theatre
2) Nurse informs BME
3) BME rushes to ICU
4) Bed fails EST (PPM)
5) Bed has a fault
6) Bed needs extra work
7) Bed needs parts
8) Patient returns
9) What happens next?

Either the department has a spare bed that they can use, the patient sleeps on the transport stretcher until the bed is repaired or the patient may sleep on the mattress on the floor.

Better to find the fault whilst the patient is out of the bed, rather than the fault causing harm to the patient.

Not a bad answer, Neil.

... or the nursing staff set up a bay on one of the regular wards (hopefully not too far away), and appoint staff from the ICU to keep an eye on the patient there. The theatres Recovery Room may be another option, depending on how long repair of the ICU bed is likely to take.

There may well be other options, depending upon the actual condition of the patient and what kit is needed (and available); for instance, it may be possible to drag an ordinary hospital bed into the ICU temporarily.

Needs must!

a good approached Geoff. Will need to revise my policy then.