EBME Forums Forums Management Medical Equipment Management Electric Beds - PAT or Medical Safety Testing

Hi
Can any one really explain, what are the safety steps taken to prevent patients from electrocuted? Checking with a safety analyzer is not the ultimate safety. I have seen earth connection or the socket get loose after checking with Safety analyzer. Interesting to hear from all
Regards
Sajeev

Sajeev,

I have never worked in a biomed dept that checks beds, but i think that any piece of equipment requires a physical inspection, which is probably as important as an electrical safety test.

Sajeev, - in a word, "vigilance" (during inspections). The seasoned biomed goes around the hospital with his eyes open, does he not?

Yes, John, I would go as far as to say that the physical inspection is more important than the electrical safety test.

Throw away your electrical safety testers, get out your spanners, and open your eyes!

Does it really take spanners to open your eyes, Geoff.
I'd go and get those glasses looked at

I check and maintain all the Electric beds in our Trust.

We class them as medical equipemnt so EME look after them as with all Electrical Medical Equipment.

(And my general observation in most hospitals is to be honest Estates have been looking after the old Nesbit evans beds......Thats the reason we are now getting Electric beds mainly as they are all Knackered due to lack of a proper maintenance program).

It doesnt take long to service an Electric bed. Full Function check, grease all Pivots, Check caster functions, Look for bent and cracked wields. Then safety test as per manufacturers guidelines/service manual.

Replace anything thats not working or "quite right" and the beds will last forever (provided nurses arn't allowed to be near them).

Hi All,

I'm new to the site, so forgive me if this information is old hat.

Anyway, working for an EMC and Safety Test House, I know a bit about testing products.

It seems to me that no-one is testing their electrical beds to the correct standard. Looking in the Official Journal of the Medical Devices Directive, the applicable standard is EN 60601-2-38 : 1996 Particular requirements for the safety of electrically operated hospital beds. Perhaps having a look at this could clear up all of the problems listed above.

As a general point, PAT testing only covers a tiny fraction of what EN 60601-1 entails.

This particular standard was discussed earlier-on I think. I have issues concerning how the rationales for this particular standard seem to classify applied parts, for the purposes of testing, to the exclusion of equipment enclosure (this is Ged Dean's interpretation as far as I'm aware but he is quite correct according to the particular standard).

The general issue of interpretation of what's enclosure and what's applied parts was raised, out of the blue, earlier in the year, at an IEE seminar I attended, at Savoy Place, concerning the forthcoming changes in medical device standards so it's one that's been concerning the people that are involved with writing them.

It was my understanding that the parts of the standards leading to general mis-interpretation and confusion associated with applied parts and enclosure tests may be addressed in the new standards. The rationale for the application of general standards and the particular standards seem to be at odds in this case it seems to me - hence the to-ing and fro-ing regards interpretations earlier-on in the thread. We can discuss whether particular standards override general standards regarding issues of general electrical safety until the cows come home I suppose.

It's clear that electrical safety testing using test equipment to medical standards is necessary at manufacture given the classification of the equipment. The issues are whether this level of testing is required for routine maintenance. My own view is that yes medical grade electrical safety testers are required for routine electrical safety tests upon medical equipment as long as testing is confined to non-destructive tests or tests that do not stress components unecessarily of course.

Yes the collateral, particular and any normative standards associated with 60601-1 would be the starting point I suppose but we are only really concerned with routine tests to ensure on-going safety not type-tests such as those carried out be a notified body, i.e. test-house.

Whatever the chosen electrical safety tester, it is without question that the majority of faults are found at the visual/physical inspection stage, in my book, thats the most important part of any safety inspection, its very important regarding beds actually, the same linear actuators mentioned in the hazard notice about patient hoists are used in the electrical versions.

Yes I agree but there is always the requirement to demonstrate to the HSE that the means of EST, whether that be visual only or visual plus electrical tests using appropriate equipment, is up to the task and that EST is performed at regular intervals. In the clincal environment the patient is vulnerable and the risks of injury are greater than for domestic use so I guess use of a medical-grade safety tester is sensible.

Anyhow I still find earth-bonding problems with IEC leads, poor bonding to class 1 enclosures, etc, and in the past I have found the occasional IEC socket breaking down/carbonised due to fluid ingress. I haven't always picked up on this sort of problem by looking so the tester does come in handy sometimes.

It's not just about using medical safety testers to look for failures or degradation of components it's about using them as a tool when checking/installing systems that are used in clinical areas - they are useful to check relevant leakage currents/paths, of course (to determine whether mains isolation is required or not, etc) and their use is a mandatory requirement by my employer, i.e. NHS, when acceptance-testing new equipment.