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!