EBME Forums Forums Management Medical Equipment Management No more PAT testing of medical equipment!

The IET have just published the latest edition (4th) of the Code of Practice for In Service Inspection and Testing of Electrical Equipment, used by those involved with Portable Appliance testing.

In the scope it now states:

1.2.1 Medical electrical equipment

Sensitive medical equipment, e.g., ECG, infusion pump, ultrasound machines, X-ray equipment etc., should only be inspected and tested by a competent person, with suitable experience, familiar with BS EN 62353. Equipment covered by and requiring inspection and testing in accordance with BS EN 62353 is outside the scope of this Code of Practice.

So now if you catch someone performing standard PAT style testing on medical equipment you can tell them they are in breech of the approved code of practice!

Yes. Good news.

But in my experience, this problem is most apparent in places such as GP's premises, veterinary practices, and so forth.

So (bearing that in mind), how are the guys from Mutt & Jeff PAT Services* going to decide what is "sensitive medical equipment"? These guys usually just come in and "test" every thing with a mains plug (and get paid for each piece of kit they apply a sticker to)!

And - furthermore - not only do the staff generally just let them get on with it, but they probably prefer to have it all "checked" anyway. Such is the climate of CYA, "Duty of Care", "Health and Safety" (both often grossly misunderstood and misapplied), fear of making a mistake (not really caring, idiocy, incompetence ... whichever you prefer) or whatever that seems to be par for the course these days. Does anyone seriously think that staff really give a damn about this issue? If challenged, they will (and do) generally respond along the lines of:- "but the equipment always passes".

Actually, it could be even worse than that. When I raised this issue with a well known supplier of ****** equipment whilst servicing some of the kit they had supplied, the general feeling seemed to be something like:- "why should we worry? If they blow up our kit, then we can sell them another"!

Meanwhile Mike ... IET:- what is that (who are they)?

* Not to be confused with that servicing company of renown:- Bodgit & Scarper!

The IET are the Institution of Engineering and Technology, better know for producing the wiring regulations (17th Edition or BS7671).

The latest version of BS7671:2008 (2011) now includes section 710 - Medical Locations.

Those who care to ignore approved code of practices will have a hard time if they ever end up in court.

The IET In Service Inspection and Testing of Electrical Equipment book is now available to buy from the link.

Has this ever been known to happen? What would be the charge?

In the UK the HSE are responsible for bringing prosecutions for breach of H&S legislation such as the electricity at work regulations.

I bet there have been few incidents that get reported to them as the stakeholders would rather not let anyone know their error in applying standard testing to medical equipment! But one death would be all it would take.

Are we still talking about PAT testing?

This whole area really needs to be gripped by the end user, all items that have patient applied parts need to to be tested to IEC 60601, as we all know, and this is generally supported by the safety blurb in the user manual.
Personal experience of this, in the MOD, some clinicians task their practice managers to buy medical equipment from a separate budget, bypassing the proper procurement route, now when I pitch up at a practice to do annual safety checks, I find unfamiliar medical equipment, I'm instructed by my engineering authority to not even touch the locally purchased items. I instruct the practice manager that I cannot electrically test them, the answer is then oh I'll get my building service contractors to pat test. When I inform them that the pat tester used by a sparky does not comply with regulation for medical items I am met with blank looks. This problem is rife across my region, clinicians need to be made aware of this very staid by possibly litigious situation

Just a small point but all medical electical items should be designed and manufactured to the IEC 60601 series of standards but medical equipment should be tested, at acceptance and while in service, to IEC 62353.

As I said earlier:-


Regardless of what Rules and Regulations might say, it is us (the biomeds) who are the custodians of equipment safety. And so it is us also who have to "keep on" preaching about it to the users (even if they don't want to listen).

In Civvy Street you can expect to do things a little differently, Glyn. For instance, we would never just ignore any other medical kit that we discover (regardless of how it got there), but check it out anyway. After all, it's just as likely - or perhaps even more likely - to cause problems as any other kit (especially if it's crap). The Biomed never simply walks away!

I get told to test to 60601, so that is what I do. What are difference in these standards, other than scrolling down a bit further on my Rigel 288? Is a 62353 more comprehensive, tighter tolerances? Really can't be bothered to investigate myself. Surely my engineering authority already know of this 62353 standard and have discounted it, well I'd like to think they would have.

Geoff, its a bit political, the IPT are pretty adamant that we don't touch any locally purchased items. In the end we would spending a resource (time) to test equipment that is not supported by the MOD, especially when that equipment can be procured properly though the correct channels, with the in place support documentation and policies.
I've pitched up at one med centre where I found 6 boscarol suction units and four GE monitors (quite expensive collectively) with no support in place, bought locally, when the med centre could've easily ordered Laerdal LSUs and Propaq monitors, at no cost to say underspend on a general budget.

So ... equipment safety goes out the window, whilst the various Directorates squabble?

It sounds to me, Mate, that the management at yet another "national treasure" needs to "get a grip"!

To be honet Geoff, we can't have clinicians just buying gear willynilly that appears Gucci, when the medics are unfamiliar in their use, will not be aeromedical approved, no passed ruggedisation tests required for field conditions.

Indeed. But who are these "clinicians"? Civvies?

Don't they have to follow the rules, then?

Anyway, Mate ... all this will be become very familiar once you walk down Civvy Street yourself. You'll come across plenty of prima donnas then, believe me.

The real worry in the UK is that GPs will now be in control of the funds yet have little idea about the requirements, especially for technology items.

I doubt they know about 93/42/EEC, 60601 or 62353 and will guarantee they know nothing about the BS7671 wiring regulations and section 710 - medical locations. I bet few GPs surgeries realise that a doctors examination room is most likely a group 1 medical location. I also bet may have a standard wall mounted angle poise lamp for examinations when it should be a proper 60601 certified light.

The dumbing down of our society is not just confined to the lower classes anymore!

Why should anyone expect them to know about any of that stuff? That's our job!

And (hopefully) they have more important things to attend to!

Meanwhile, "dumbing down" is all part of the Plan - but don't get me going on that (but if you want, why not Google "Common Purpose" for starters)!

Perhaps it's just as well that some (many, I hope) of us not only refuse to be "dumbed down", but are also willing to "step up to the plate" and deal with issues head on! It's what we used to refer to as "the burden of competence".

Any body got any comments on standard PCs in the "medical environment"?
I asked the MHRA about this as I was asked about a PC in an out-patient setting. Thier response was that it should be taken as a standard not medical environment as the patients were mobile and not comnnected to it - the same as the drinks machine in the waiting room.
But how about a PC on a nurses station that "ill" patients will pass by? It might be further from the bed that the defined area but patients are not static.
Robert

But is "passing by" the criteria?

How about:- "connected to" (or not)?

There again, I suppose there is always the possibility of a "trip hazard", judging by some of the "poor installations" (not to mention "rats nests" of cables) I have seen in some ICU's.

But ... PAT testing on PC's and similar kit? Not such a good idea, in my opinion. Best let the lads stick to kettles, toasters, and stuff like that, I reckon.

It is essential that those working with medical equipment make themselves aware of the contents of the wiring regulations, BS7671:2008 (2011), especially section 710.

The definition of medical locations is as follows:

Group 0

Medical location where no applied parts are intended to be used and where discontinuity (failure) of the supply cannot cause danger to life.

Group 1

Medical location where discontinuity of the electrical supply does not represent a threat to the safety of the patient and applied parts are intended to be used:

- Externally
- Invasively to any part of the body except where group 2 applies.

Group 2

Medical location where applied parts are intended to be used, and where discontinuity (failure) of the supply can cause danger to life, in applications such as:

- Intracardiac procedures
- Vital treatments and surgical operations

If interested in the latest advice on PAT testing you can download a free guide from the HSE here.

The recommendations made in this document are also reflected in the IET Code of Practice for In Service Inspection and Testing of Electrical Equipment (4th edition).

Our company carries out 2 types of testing.. PAT and Medical electrical safety testing ( Any medical equipment that is plugged into the mains and makes physical contact with a patient ) the kit cost us quite a lot. It's scary to hear that there are other companies using standard PAT testing equipment on medical devices

I know they usually get paid per item and would a non-specialist know a piece of medical kit anyway, if it was in a cupboard.
I dfoubt if they were deliberately doing it, just testing everything in sight.
Robert

It's even more scary to hear that you've (apparently) only just learned that is the case. It's being going on for years!

@Robert: yes, that's how it's usually done (as reported earlier). Surely everyone is aware of this?

( Apparently ) ??? I haven't ' just ' learned that this was the case. I have known for 2 years ( The length of time in my current role ). I was just stating that it is scary that this is still going on with other testing companies. That is all..

To my mind, what is far more "scary" is that the "managers" of these places don't seem to have much of a clue about what electrical safety is really all about (apart from simply "ticking boxes", that is).

For instance, does anyone have any figures regarding failures during electrical safety testing at clinics (NHS, Private, dentists, vets etc.), whether by PAT or "medical" testing regimes (that is, how often does the kit actually fail) ... for:-

1) Medical equipment
2) Domestic equipment (kettles etc.)
3) Kitchen equipment (refrigerators, microwave ovens)
4) Office equipment (PC's, photocopiers et al)
5) "Mains lead extensions"
6) "Toys" (mobile phone chargers and the like)
7) Wiring and electrical outlets*
8) Lighting (especially the risk of fire)**

What I am getting at here is ... let's "get real" about where the actual risks lay!

OK ... just to speed things up, here are my suggestions:-

1) Medical equipment EST failures -> never
2) Domestic equipment EST failures -> sometimes
3) Kitchen equipment EST failures -> rarely
4) Office equipment EST failures -> never
5) "Mains lead extensions" -> should all be binned!
6) "Toys" EST failures -> often!
7) Wiring and electrical outlets -> sometimes death-traps
8) Lighting -> often hazardous in certain situations!

* Including incorrectly wired and/or poor (or no) earth!
** Usually due to incorrect lamp used in a particular fitting ... or simply being "always left on"!

Just out of interest (and more or less within the bounds of this topic):- what do your Company policies say about mains plugs and mains plug fuses, I wonder?

Geoff, just had a word with a few of our engineers and this is what they said:

1) Medical equipment - Rarely
2) Domestic equipment (kettles etc.)- Rarely
3) Kitchen equipment (refrigerators, microwave ovens)- Rarely
4) Office equipment (PC's, photocopiers et al)- Rarely
5) "Mains lead extensions" - Occasionally
6) "Toys" (mobile phone chargers and the like)- Rarely
7) Wiring and electrical outlets* - we dont offer this service ( Different division looks after this )
8) Lighting (especially the risk of fire)** - same as above

One of the engineers said that they always run a medical electrical safety test after each repair as standard. We do have a few hospitals and GP surgeries that request this service on an annual basis..

Can I stir the pot?


PAT testing

Back in the dim days of pre history I set up the PAT testing regime for the Works Department at this Trust, initially the guys doing the tests found a lot of problems with Domestic equipment - mostly leads and plugs, over half of the equipment in the Catering Department failed, they threw out most of the extension leads and had relatively few faults with other PAT tested equipment. They did not cover Medical Equipment, and fixed installations aren’t PAT equipment and are subject to another set of requirements.

In subsequent years the number of faults found were a fraction of the first years.



60601 or 62353 testing

On too many occasions to mention I have failed equipment during a visual inspection (broken cases, drop damage, mains leads and patient leads that have been run over or stretched etc).

In the good old days I saw my fair share of moulded leads with poor earth continuity and the odd piece of Medical Equipment with a doggy earth.

I can remember 2 units that failed electrical isolation tests, both due to impact damage (one in a reps. Boot, and I already knew from the visual inspection to expect problems).

I have also had some failures of equipment that was not “Hospital Grade”, and was not manufactured to pass 60601 or 62353 tests.

But apart from the non Hospital Grade equipment I can not remember any failures in 20 plus years of using medical standard electrical testers that would not have been picked up with a PAT tester.

Am I alone in this? Or is it evidence of a selective memory?

Lee

No Lee, you are alone ... your experiences are probably typical, I would suggest.

For what it's worth, my own experiences certainly bear out what you are remembering here. But luckily for me, most of my "biomedding" was done overseas, so I have also seen a fair number of "unusual" situations as well (which I won't go into now).

Over the years I must have discovered hundreds of hazardous conditions, but (as I have probably mentioned before) almost all were able to be picked up by simple examination, my multimeter ... and, my nose!

So where does all that leave us? Thousands of man-hours "wasted" carrying out electrical safety tests? No, not really, just as long as the tech carries out an examination of the kit (plug, fuses(s), condition of the cable ... and all the rest) as well!

But ... when it comes to stuff like "mains on applied parts" at every test - or, worse still, carrying out EST on "auto-pilot", let's just say I'm not a Big Fan!

Just picked up on this thread. I pulled a contracted PAT Testing person to one side a couple of years ago who had been doing the ususal 'test everything' regime because of the piece-work payment. He claimed to have never been told anything specific about testing medical devices, so as a guide I showed him the B/BF/CF symbols & advised that anything bearing these marks should be left for us (biomeds) to deal with.
On another note, more recent PAT tests were carried out by 2 young lads - 1 was sitting using his mobile while the other simply attached labels...
The last bout of testing carried out 'in-house' here saw plug tops loose, chunks missing out of IEC plugs/leads & the failing of an extension lead used in our workshop because it was "Open Circuit Between Live and Neutral" - Well I should hope it is!
Finally, I also wonder how many people take the time to determine how many enclosure parts there are on a device before carrying out an electrical safety test and also testing every earth on equipment that carries multiple mains outlets? It surprises me that even manufacturers that supply a safety test result with their new equipment fail to do this!
Also many suppliers still supply mains leads with 13A fuses fitted in units that have a 10A IEC plug at the other end & sometimes nothing greater than a 6A cable.
Just some obvservations/thoughts!
And breathe....

Yes Paul ... yet more examples of why the biomeds need to be ever vigilant (regardless of whomever it is who's supposed to be carrying out "electrical safety" checks).

I like the bit about the lad playing with his "social media" toy, by the way. I'm sure I'm not the only one who sees it going on all the time. Not just the "working lads", but the nurses too (and almost everyone else as well, it would seem). Needless to say, if that bloke was working for me he would be shown the door. That way, he could play to his heart's content (in his own time)!

Then he could be struck off the register and would never be able to repeat his dangerous actions....... OOOps wrong topic - or is it?
Robert

Where's the threat to "patient safety" from some useless ned passing the time playing with his toy?

In fact, I would suggest that by not doing his PAT testing, he's more likely to be diminishing the risk (of damaging the kit, at least).

But he is certifying the equipment as safe when it might not be. Actually doing the PAT test (I think that is tautology*) might have identified a fault which could harm someone.
Robert

* PAT = Portable Appliance Test
"PIN Number" is another one that annoys me PIN = Personal Identification Number

I doubt that a ned like that would have identified a fault even if it had jumped up and bit him in the [censored]!

Bottom line:- leave electrical safety testing of medical equipment to the biomeds ... and restrict the "lads" to kettles and hand dryers (if that).

Meanwhile, here's another one for you, Robert:- "LCD Display"

... and, in similar vein, but not real tautologous* (but perhaps one that you may not have come across):-

"The Royal Monmouthshire Royal Engineers" (the only unit in the British Army with two Royals in its title - and the most senior regiment in the TA).

* OK, I just took a guess at one!

Sorry for going of topic a bit but snowed in.....
Heres another Few:
SAM Missile (Surface to Air Missile)
POST Test (Power On Self Test)
RAM Memory (Random Access Memory)

Keep 'em coming, Ed ... but Robert has been known to go on about diphthongs as well (so you had better get ready)!

BTW: the thought occurs that you may not be too far from Monmouth yourself!

The complication with all this 'PAT tester should not test medical equipment etc.' is that NO where in any UK law is it mandatory to PAT test. The IET (formerly IEE) write a code of practice, and that is all it is.

Under HSE and the electricity at works act you should undertake to ensure that electrical items are maintained in a safe condition and it is up to you what measures are chosen. The IET code of practice for the testing and inspection of electrical equipment is just that, a code of practice and can be adopted or ignored as long as a system is put in place to ensure that electrical equipment is maintained in a safe manner.

Barney

Hello Barney ... where have you been, Mate?


Yes ... (and as I keep saying ) it's the biomed who is the Responsible Person - or, as I like to put it, the Custodian of Electrical (Equipment) Safety. It's known as the "Burden of Competence", you know!

Having only very brief experience in the UK, I ask,..is it not possible to separate entirely the electrical testing of "Portable Equipment" from the electrical testing of Medical Equipment or is it the same team employed to carry out testing on both groups??
Whilst there has been much said about the EN 62353 at least finally there is a standard that is far more pertinent to our field than the EN 601, in its various editions, ever was.
At last we have visual inspections, electrical safety and functional/performance testing grouped together, I'm sure you concur that a diathermy or similar that sails through its EST but erogates twice its rated output is never going to be deemed hazardous during an EST alone.
However the fly in the ointment is just how much time and money do have to carry out all of the required testing and whilst I agree whole heartedly with Geoff about auto-pilot EST I can still remember using an in-house built " break out switch box" ,milliohm and milliampere testers testing to BS 5724 but there were no time or monetary constraints(read HM Armed Forces).

Although it may be possible to provide lists of non-medical and medical electrical items, how are you going to deter the guys from Mutt & Jeff PAT Services, who (as has already been mentioned) are happy to just come in and "test" everything in sight that has a mains plug on it (and get paid for each piece of kit they apply a sticker to)! Different coloured mains plugs? Yet another "sticker" (colour-coded "dot" ... whatever)? Or someone to (waste time having to) accompany them the whole time - who may as well be doing the EST's themselves?

To my mind, the "answer" (in hospitals, at least) is to bring back the whole thing (electrical safety testing of equipment with a mains plug) squarely under the control of the biomed department. Yes, kettles and all! If the biomeds lack sufficient manpower, then they can always seek to bring in someone from outside - but the exercise should always remain under the control of the biomeds!

But surely you haven't waited until now (that is, with the introduction of 62353) to be "told" to carry out visual inspections, functional and performance testing, and electrical safety tests at the same time, Malcolm? We used to call it PM ... or, if you prefer (as I do), I/PM.

Even back in the early days of "Electro-med" in HM Forces we used to do all that, although (in those days) we used to call them (monthly, quarterly, annual etc.) "inspections"! Never mind 62353, 601, or even 5724; what about HTM-8? Ha, ha.

But yes ... those were also the Happy Days when we had to "make do" with an Avo 8 and a (hand-wound) Megger. Plus (if you were lucky, a Camsafe - which no-one else on here has yet admitted to ever having heard about)!

... sorry, guys.


And now that acrostics have been in the news, no doubt we can also expect to see (or perhaps not, as the case may be) some of those on here, too.

You have been warned!

You're right Barney, but the problem is that the GP surgeries and other parts of what were PCTs and are now CCGs find that calling in a PAT company is the easiest way to prove that they have had things regularly maintained. Everything gets a sticker, and they get their QOF points (or whatever they are called now, because that was a PCT thing...)

I found this thread searching for help regarding equipment that had been in rude good health until a recent PAT event, and which has failed suspiciously soon since. The company which did the tests has, before now, "safety tested" a power supply pack with the most mangled wire you ever saw, and didn't balk at at sticking their equipment ID sticker and a "passed" label on it. I have yet to find out what their price per unit is, but that is how they seem to work...

If we are going to play the regulation game properly, why is there no means of legally stopping these shysters who PAT things that shouldn't be PATed and sometimes blow things up?

It is right that the GPs don't know the difference in the regulations - they shouldn't have to know, or have to watch out that they are not being ripped off by double charging or false claims of competence from the testing companies. If the companies cannot offer an honest service, they shouldn't be able to get into medical settings in the first place.

There is a (well-established) company active in GP surgeries (and such like) advertising for staff on here at the moment.

Take a look at their website (which is very good). Most of the "questions" are answered there.

CCGs
QOF

... any more?

Hello Clare

As I have previously suggested, where does it ever say (except on literature from a PAT or Medical Testing company) that you have to electrically test any portable equipment. The fact is you don't, whilst it may be a good idea and sensible all the law expects is that you put into practice reasonable measures to ensure the safety of electrical equipment. In most cases I would advocate all that is required is a formal visual inspection, the H&SE certainly do not have their computers and other office machinery electrically tested each year.

It is my opinion the health and safety culture has long ago left all common sense behind (common sense just gets in the way).

As for medical equipment, most equipment in hospitals are not tested as frequently as office machinery that seldom moves, furthermore the items tested are more than often connected to IEC leads that have never been tested. IEC leads pose a greater threat to safety than most medical equipment. So, in a PCT Doctors' surgery perhaps a PAT test is better than nothing. After all, after passing a visual inspection (the most important test) what hazard does a class2 (B or BF) nebulizer for example pose a patient? Other than a visual inspection what is the point of electrically testing a class 2 item anyway?

I'm sure that I will receive some replies.

PAT testing / electrical safety testing portable equipment has become a FARCE due to misleading information from companies profiting from the rip off.

Perhaps the link below will rule out all the lies and myths regarding electrical testing.

http://www.hse.gov.uk/electricity/faq-portable-appliance-testing.htm

That's a good link, Barney.

But just to re-cap:- the OP (original post to this thread) was little more than a Clarion Call to BS EN 62353. But Mike was (is) right:- there is no need for "PAT" testing at medical premises.

Proper (medical) EST is a different proposition, however; if only in that it is (normally) carried out by folk with a bit of understanding of the issues surrounding the "clinical environment" as a whole.

But I believe that the emphasis placed upon electrical safety testing (EST) per se is slightly misguided, and that it is far better to think in terms of I/PM (inspections and preventive maintenance on a regular, scheduled, basis).

I/PM should include EST when and where appropriate (that is, in almost all cases involving medical equipment - if only on the basis of "seeing that we're already there anyway" [in front of the machine, and in the clinical environment]). And ... as I must have said at least a zillion times on this forum ... the real value of I/PM is that it brings a technician into contact with each and every machine on a more-or-less regular basis.

And any technician worth his (her) salt should "do the needful" (whatever is required to return the equipment to full and safe serviceability) whilst the machine is in front of them.

"A Stitch in Time Saves Nine" ... "A Place for Everything; and Everything in its Place" ... and all the rest of that Good Stuff (I'm sure y'all get the picture)!

Looking at it from another angle, I wonder what will happen when equipment in GP surgeries gets more advanced. So far the demise of the PCTs has meant that more GP surgeries are now carrying out procedures which previously would have been carried out in a hospital's outpatient department or clinic. Also given the push to treat more patients in the community, we're going to start to see more advanced equipment with district nurses.

Thus I wonder how long will it be before we start to see equipment coming in faulty as a PAT test company has given it a zap and not followed the correct shut down procedure?

Yet again the "answer" (surely?) is to get some real biomeds in there ... and give "Tester PAT" the elbow, once and for all!

Surely testing of medical equipment is more than just sticking it on an electrical safety tester. I would have thought that a few basic checks of function were needed as well.
We should stop talking about "electrical safety testing" and emphasise "safety testing".
Then Testman Pat would not get a look in.
Robert

Yes. Yes. Yes. But now that healthcare is being "driven from the other end" (as it were), the primary care medics, doctors, managers, bean-counters, commissioners (whatever) don't seem to appreciate the difference.

In many ways it's "back to square one"!

Has it been safety checked? - Yes - box ticked.
Can it be done more cheaply next time?

The way of the brave new world

Robert

RoJo is correct, of course there is more to checking that equipment is safe to use and gives accurate results than sticking a label on it. Unfortunately this is the tick a box stick a label on nonsense society we have become. I have been involved with electrical testing in its many different forms and I can say that PAT testing is a complete farce that exploits peoples' ignorance. This results in equipment that should be electrically tested being missed and other equipment being unnecessarily tested. It is not much good Joe Pat sticking a label saying test passed, safe to use etc. on a Vitalograph when the bellows are out of calibration, but whose fault is all of this? Is it Joe Pat trying to earn a living, a busy practice manager who just wants a bit of paper saying test passed or Med Eng Depts charging too much?

The answer is; what they want is a good dependable engineering journeyman (like myself and other greybeards) to go around local surgeries and advise them on what needs testing and calibrating and what does not. In fact after I retired a number of surgeries contacted me asking if I would continue in a self employed capacity. Perhaps I should have, but due to the high cost of the test equipment I declined. However I have always thought it a good idea to have a central pool of this equipment available for hire for people like myself to earn the odd shilling, even a club of greybeards. Until then when I visit my local surgery I expect to see Joe Pat labels on all and sundry.

If anything I would say that it's the complete opposite, one thing I have noticed since the demise of the PCTs is the demise of Joe Pat. If anything it's one thing to sell PAT testing to a couple of GP surgeries or a bunch of district nurses, but it's far harder to sell it to commissioners and groups of GP's.

It just takes one Pat tester who is 'servicing' their medical equipment to not fix the equipment and refer it back to the local Med Eng department and they've lost the whole area. Therefore I'd say stick to the day job Barney, I think you'll find there will be less demand.

You forgot to mention insurance, Barney.

@Robert: here's what will happen:- all will be well in this Brave New World until there are a few juicy "incidents". Then "they" will be running around like blue-arsed* flies trying to find someone to come in and sort out the mess. Until then, keep your powder dry. Patience my friend.

@Chris: you're not reading the posts. For Barney and many other "greybeards" (including myself, by the way) there is no "day job".

* Are they any good at covering their blue arses, I wonder?

Well Geoff doesn't look like those "greybeards" will be in luck then does it. Since the start of the changes I've been out to some locations like a yo yo. I get a feeling that I visit one department (usually run by the Trust or commissioning group) and get noticed by another section. It does seem that if your actively visiting a site you'll have an advantage over somebody who just turns up for the day and will never be seen again until next year.

Yes Chris, we know how it works. But don't worry, this "greybeard" at least is happy enough to leave it all to you.

Meanwhile, back at the thread ...

How about this thread, Mike ... it's probably the most recent one that mentions 62353.

When you were saying before about folk needing to adopt (follow) 62353 ... actually, I agree with you.

But, as I don't have the actual document to hand (but only John Backes' handy booklet), perhaps you could spell out exactly what's involved.

For instance, can we regard 62353 simply as a sub-set of 60601 ... thereby allowing us to carry on using our old EST's (Electrical Safety Testers)? Or do we need to think about investing in new test kit? And apart from the Rigel *288, which others are available?

And, apart from the introduction of "new models" of testing methods (the Differential, and Alternative methods), what compelling reasons are there to "change over" (from previous or current testing regimes)? BTW: do those two new testing methods have any great (practical) value, would you say?

Also, where is 62353 mandated? DB- (or MDD) this or that? What's the latest (or current) status of 62353 from the "official guidelines" point of view (in the UK, that is)?

From my own (limited) research it also gets a mention in other domains, by the way. In some ECRI documents, for example.

The bottom line being:- if folk want to align their procedures with the latest thinking here, what do they actually need to do? What steps do they need to take?

* There's nothing wrong with Rigel test kit, but its always nice to be aware of what else is out there!

Think of a pyramid with the law and the top and the multitude of guidance documents as the base at the bottom. Standards, which are interpretations of the law, sit above all the guidance documents in the order of things. This is a little understood aspect of the legal side of things. Therefore, for the UK, this means BS EN 62353 is the document all those who are involved in medical electrical equipment need to use.

A guidance document will never take precedence over a UK or international standard in any legal proceedings.

Most 60601 based test equipment, can be used for performing 62353 test with some slight adaption of procedures, but real time and cost savings can be made if you use dedicated 62353 testers and adopt the alternative methods for leakage measurements, where practical.

And presumably all that is covered on courses being run these days at ... wherever biomeds get their training these days?

Meanwhile, as background, here is one of the many articles by John Backes to be found on the web. Others may be found here.

Now, after re-reading the first article I linked to, I can in part answer some of my own questions. So, here goes:-

The Differential Method copes with secondary earthing scenarios such as those that may be encountered with isolated mains power supplies in operating theatres (on pendulums, booms etc. - the clue being that a LIM will be around somewhere nearby). Presumably because it doesn't "need" an earth to take its measurements.

The Alternative Method can be used to determine current leakage prior to activating the equipment (why would you want to do that?), or when testing in an IT environment etc..

Good, practical stuff, then. Although I'm still not clear about the "IT environment" bit, I must admit (no proper earth available, perhaps?).

The problem with an IT supply is there is no reference of the mains supply to earth, therefore the applied test voltage (the mains) would not be the full amount. The higher the earth-neutral voltage the less accurate the leakage readings will be. In other words the direct (like 60601) and differential methods need a TN-S supply to give accurate readings. (The N-E voltage should be less than about 7V.)

The differential method is safer for those performing any tests, including anyone else who may be contacting the equipment (or a connected peripheral), as the earth connection is never broken. This is also ideal for items that are allowed a higher equipment leakage current, such as mobile x-ray units (2mA rather than 0.5mA).

The Alternative method is especially useful where a device is PC based so needs a long time to boot up and shut down between test, such as many ultrasound units. No boot up and down required, no switching of mains polarity, no messing around. The measured value will be almost identical as an open neutral 60601-1 test, which is why the limit is 1mA rather than 0.5mA. This is the real time and therefore money saver!

Yes, your last point (especially) is a good one.

Although it could be argued that "real" electro-medical equipment has no business being in an "IT" (that is, non-medical) ("floating earth", or whatever) environment in the first place! I wonder what the manufacturers' documentation - not to mention legal teams - have to say about all that?

But I can feel another box on the test sheet (or field in the database) coming on:- one that says which test to use (for each piece of kit).

Otherwise, each time the tech comes along to carry out his annual (whenever) EST, any hoped-for time saving is likely to be negated by him puzzling out which test method to go for!

Once again the need for good record keeping is emphasized; as in:- "what did we do last time"?

Leakage current test methods:- Rigel .pdf.

Vignesh,
I have deleted one of your posts before as it was an advert for your equipment.
Please do not post adverts again or you will be blocked from this site.
RoJo

Hi Mike X,
Equipment (X-ray, ultrasound and laser therapy), type tested to 60601, but used in the veterinary sector, can anybody confirm or guide me to where the guidance is for vet market. I personally believe that if the equipment has been type tested to 60601, then it should be tested to to the 62353 standard throughout it's life irrespective of where it is used.

Thoughts please.

Many thanks in advance.

Hi Winston,

It makes no difference that the medical electrical equipment is being used in the veterinary sector. BS EN 62353 (IEC 62353) scope includes all ME Equipment and ME Systems, which comply with IEC 60601-1.

As far as I know all medical electrical equipment used by vets will conform to the medical device directive (now medical device regulations) and will meet IEC 60601-1. Therefore it should be tested following 62353.

The IET Code of Practice for In-Service Testing and Inspection of Electrical Equipment specifically excludes such medical electrical equipment from its scope and refers you to BS EN 62353.

Hope this helps.

Mike.

Hello Winston

I'm wondering why you had any doubt about this (why you would have thought otherwise); has some "expert" been giving you "duff gen"?