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

1) EN 60601-1-1 states that the accompanying documentation should include:
"additional measures which should be applied during preventive maintenance".

2) All manufacturers should employ a series of safety checks on their products as they come off the production line. Perhaps you should ask them what they do, and use the same methods

Are you currently working in medical engineering, in a maintenance role, Jonlar? I guess not.

They should and they do as far as I'm aware - to the applicable medical electrical standards I presume although sometimes I wonder about this. As I stated before - carrying out manufacturers tests, that must include some of the basic medical electrical safety checks listed in standards, may not always be appropriate for routine testing and the manufacturer may not be inclined to give such advice.

Just to stretch the point - Hi-pot testing and other electrical stress tests would definitely not be something I'd be inclined to perform on devices routinely for example since they may be damaging to equipment if applied either inappropriately or incorrectly. Tests that might be performed at manufacture or during type-testing in fact.

As you say one could rely on the documentation provided from the manufacturer to decide on what safety tests and inspections to perform i.e. look in the service manual. But in "standards-speak" the difference between "shall" and "should" can be a world apart as I find on a fairly regular basis when it comes down to equipment markings and documentation in particular.

The notified bodies, i.e. test houses, do not always ensure that the manufacturer has included have all the information that's required in the service manuals and operators manuals thta's laid out in the standards (nobodies perfect and this is the real-world).

Finally getting technical representatives of a company to sign off the electrical safety tests that should be carried out routinely by ourselves and how they should be carried out explicitly (if these are not included in the existing documentation) and backed up with authority is difficult in my experience.

This leaves people like myself to perform generic electrical safety tests on equipment, routinely, relying on the tests pre-programmed into medical electrical saftey testers (to the appropriate standards the equipment/manufacturer claims to meet). The tests that the manufacturer should be using off the production line.

Dear Sir/s,
Pls. advise if you can quote for the following, for Riyadh, Saudi Arabia, Equipment - Electric Bed
Manfufactuurer - Stryker Medical Corporation
Model 203500 00 00
Serial # - 000 715 129
Description - Fowler gatch Motor Assembly
Part # - 2035 300 705
Qty. 01
Akhtar Rasheed Mallick
Sales and Marketing Manager
Middle East, India, Pakistan
T- 00966-1-406-7766
F- 00966-1-4011-620

Akhtar,

We are discussing technical issues regarding beds - NOT selling parts for them.

If you need this information please contact Stryker or their agent in Saudi.

…why not send the guy a quote?

Following the long discussion about what is, or is not an Applied Part concerning electric beds I'm glad at North Middx. Hospital that our MEMU has nothing to do with them and they are all dealt with by our Estates Dept.
On the question of Applied Parts - take the electric chair as used in places in the USA. Is the bit that they connect to your head an applied part? If so, do they ever test if for electrical safety?

As we all know, the tests in question should only be applied to “medical electrical equipment”. I doubt that the executioner’s electrical chair falls into that category. But what about the hospital electrical bed? What is the consensus there? I would have thought that simple PAT testing was sufficient myself.

Hey Geoff,

You surely must know that I did have my tounge stuck in firmly in my cheek with that posting.

However, I agree with you that a simple PAT test should suffice for an electric bed and if you were worried about the frame then this should treated as an enclosure leakage problem for the purpose of a Medical Electrical Safety Test.
I don't want to enter into this long debate about what is, or isn't an applied part. However, I've always understood this to be a specific connection to the patient for functional purposes e.g. ECG lead/pads etc. If the authors of IEC60601-1 say that if a patient happens to touch something then it becomes an applied part I think that they could be somewhat misguided. Perhaps, they should talk to Engineers and Technicians who carry out these tests every day before making these statements. (Oh no, there I go being contravertial again, which will probably mean that this debate will continue on-and-on!)

Geoff,
Did you mean that instead of an electric chair the condemned person has an electric bed to make their last moments more comfortable?
Robert

PS When I started out I did a lot of PAT testing but my hand soon became callused.

PPS When I started out I did a lot of PAT testing but she started to complain.

PPPS Is it not tautologous to say PAT testing? It should be PAT or PA testing surely.

Robert, I assume you are talking about all that Meggar-cranking that went on back in those days. Back when I started, that was all we had – a Meggar and an AVO. But, there again, we were “only” attempting to test to HTM-8. Then along came the CamSafe (remember those? Perfectly adequate for measuring “risk” leakage current). After that the Liverpool Tester, which spawned the Rigel etc. etc.

Ian, for me the real point is that if electrical beds are looked after by Estates (Facilities, Hospital Engineering or whatever – non-biomed at any rate), surely they will always default to simple PAT-type testing (if any), whilst if biomed looked after the beds, they would tend to get out the Rigel et al. And, yes, I have seen both scenarios many times over.

Lots of similar examples come to mind – lab equipment, x-ray systems both mobile and fixed, refrigerators etc. etc.

It would serve our profession well if we had clarity about what type of testing is applicable where (and why). In my humble opinion, far too much time is wasted carrying out (sometime esoteric) electrical safety tests, often to the detriment of the real work (which is, should anyone need another reminder, the maintenance and repair of in-service medical equipment).