EBME Forums Forums Maintenance Technical Assistance Class III equipment

I would not count a hospital ward a "low risk environment" especially with patient connected equipment.
Robert

If a piece of medical equipment is Class II within a patient environment, (so long as it does not have conductive patient applied parts), does it really require annual routine electrical safety testing as long as its working?
For example drug infusion equipment in a docking station, such as Carefusion, (recommended performance verification every three year).

Define the risk to patient safety by not safety testing every year? I would suggest the reasons may be anecdotal, as opposed to factual.

Class II equipment (medical or otherwise) is designed to fail safe, irregardless of the environment , whether that is a building site, or a hospital ward.

The main electrical hazards in a hospital ward tend to be from overloaded sockets, and damaged trailing mains leads of Class I equipment, where earth bonding fails, or leakage currents combine. This is where the user check and visual inspection is of more value. Inspection should precede testing.

In comparing the potential for the risk to patient safety between Class I and Class II Medical Equipment, I would suggest that Class II presents a lesser potential hazard regarding electrical safety or risk of electric shock, and the local routine inspection and testing regime should reflect this.

How do you know whether it's working or not?

When it's been reported as "not working" by the staff. Yeah, right.

The answer I'm looking for here is:- "by testing it"!

When? During PM visits. So whilst you're at it, may as well bung it on the EST as well, I would have thought.

If you offered Carefusion a contract to come in and check their kit once a year, do you think they would decline?

IMHO, (and regardless of whatever claims manufacturers make when trying to sell their stuff) all in-service biomed kit should be checked out at least once a year. In fact, in the past I have always aimed at twice a year. And some of it more often than that!

Especially when it's "protected" by the C.E. mark? Again, yeah, right.

And "user checks"? Don't make me laugh!

But you're right about where the more obvious electrical hazards lie, Sean, but that doesn't mean that biomeds should let their guard down, so to speak.

Once you've dragged your test trolley into a ward, you may as well test the whole lot of it (that is, everything you find with a mains plug hanging on - or off - it), I would have thought.

From what you're saying there it sounds like you are keen to visit the wards (wherever) more often than needed:- now and again for Class I kit, and then once in a Blue Moon to check out Class II. Where's the sense in that?

Come on Sean, you're making it sound like you're trying to make a case for not doing things in the time-honoured, but well-proven ("customary", "anecdotal"?) fashion.

... anyway, and with respect to Steven's original post:- what about Class III?

My point entirely Geoff, you can combine planned performance verification, with electrical safety tests (if required).
The example I gave,(Carefusion equipment) requires performance verification every three years, so safety test at the same time!

Between these scheduled (planned) periods, there is no requirement to electrically safety test this equipment.
Faulty equipment requiring reactive maintenance would trigger a requirement.

But if the equipment is not faulty (in use,and the clinical staff can confirm this),scheduling a visual inspection between planned performance verifications, is more than adequate. In many cases the equipment is in constant use, and they wouldnt release it for safety testing, this is recorded as "visual inspection only".
I have confidence in the equipment users to spot when the equipment is faulty, especially in high acuity areas. They will let you know if the equipment is working or not, and in most cases identify the problem. Credit where credit is due!
Your assertion that user checks are innefective, does Clinical staff a disservice, that may be your experience but not mine.

If the Technical Authority for the kit is confident enough to relax the periodic servicing interval from one year, to three years (that includes electrical safety testing) so am I.
Funnily enough, I dont feel the need to pop down annually with a safety tester, just because "weve always done it that way"

Correct assumption Geoff, just because its always been done in a time honoured and anecdotal fashion, does not mean that current practice is still valid and proportionate to a perceived risk. Every now and then it doesnt hurt to question how we do things, its called risk management.

... but:-

Fair enough. I won't argue about "high acuity areas" ... especially the bit about difficulty in accessing the kit. But (again, in my experience), problems are just as likely to crop up in what we might call the "forgotten areas" of the hospital and its dependencies. OPD, or off-site clinics, for example, where the staff may not always be so "techno-savvy".

Anyway ... what do you propose in cases where Manufacturer A recommends (or should that be "mandates") a six-monthly I/PM cycle, whilst Manufacturer C (of similar kit let's say, sitting alongside in the same department) says that once in three years is enough.

Do you just follow the "Technical Authority" (do you mean the manufacturer, or is there some other body I'm not aware of), or do you implement your own policies (based upon experience, judgment, consistency "across the board", feedback from the PM system, good practice and what-have-you)?

BTW ... perhaps I had better remind you (and others) of my own personal (and often stated) preference for the Risk-Based PM model - less anyone gets the wrong idea!

"Anyway ... what do you propose in cases where Manufacturer A recommends (or should that be "mandates") a six-monthly I/PM cycle, whilst Manufacturer C (of similar kit let's say, sitting alongside in the same department) says that once in three years is enough."

A fairly extreme example, but nonetheless, examine the risk, decide to harmonise I/PM cycles if possible (which may include decreasing or increasing frequency) propose changes, then get them signed off by a representative section of interested parties.
(In reality, if one manufacturer recommended a six month interval and another manufacturer of similar kit recommended a three year interval, after looking into the validity of the claims, I would be looking standardise on the more reliable kit that required less maintenance).

You may deviate from the technical authorities (manufacturers) recommendations, either increase of decrease the frequency, based on pertinent factors.
So long as you have completed a fully documented, and approved risk assessment, the main point being to involve interested parties from the outset.

Checked the Philips FR2, no markings on unit to indicate electrical safety classification. Perusal of the specifications are likewise, less than enlightening. Plenty about EMC and ionising radiation though.
This kit does not requires any routine testing at all, apart from checking the battery life indicator.

Perhaps the PPQ may provide the appropriate answers?