EBME Forums Forums Management Medical Equipment Management Risk assessment of home based devices

Has anybody carried out a general risk assessment for medical devices that are to be used primarily within a patients home environment?

Rather than a specific assessment detailing the devices maintenance requirements, I mean a general overview assessment?

Kind of a tick sheet to follow when sending a device out to a patients home.

HI, If it helps, my view is that the main additional risks will come from the patients' home mains wiring installation. All devices are built to protect the patient with a single fault condition. The medical location in a hospital, if fully compliant will ensure that the single fault condition is not affected such as inadequate earth systems etc.
I recommend that before a device is used in a patient's home is that the sockets are checked with a simple socket tester. these can be used by anybody who is capable of seeing that the three green lights indicate no fault. This is the most that can be done.
If it does indicate a fault, the only next step is that it is reported upwards and if necessary, an electrician inspects the home - and then the system will fall apart as the faulty wiring needs to be addressed - which as you can imagine will be tricky to decide who pays for it!
Older people are more likely to live in a house that has no incoming separate or TNC earth and may not be bonded etc. This goes on. Anther hurdle is that you can't modify a section of the home unless you can do something that is a justified upgrade so the device can be used....this is minefield territory....
To conclude, I would not have dialysis carried out on myself with a non-compliant wiring supply system.

@Ian. Have you anything to say about the efficacy of the suggestion posited in another thread about providing an in-line 10 mA RCD for use with every Class I item of equipment loaned out into the community?

Sorry about the long sentence.

Hi Geoff, can you send me the link please? I’m on my phone and search didn’t find it

In short it sounds like a reasonable additional risk reduction method but using a socket tester as well will spot any other wiring faults.
However, an RCD won’t protect against any over currents if the wiring supply earth is missing. It can be good back to the supply but then it goes nowhere.
The earth is there to blow the thermal trips or fuses.
There are still plenty of homes out there that have no earth system in place or a compliant mains network earth (Terra) provided.
The father in law is 91 and I arranged to have a TNS earth recently provided just so we could bond the gas meter in case the back boiler goes. It needs a full rewire but can’t because it would wreck his decoration so that would mean weeks in a home which he would object to. My point being, you could justify at least an earth to be fitted free by UK energy if it gives a low loop reading or have a rod fitted. Problem is - doing half a job is not ideal and I’m only writing about it to show a full rewire is so disruptive.

The MHRA have a guidance checklist for such use: https://assets.publishing.service.g...data/file/403401/Devices_in_practice.pdf

You can worry less about the electrical installation in the home if the devices you send are class II (double insulated)!

In some rural locations only a TT supply is available, which will mean the electrical installation is protected by an RCD.

Maybe include a reminder that an electrical installation condition report (EICR) is recommended every 10-years and is mandatory every 5-years in rental properties.

See #77326.
@Mike: that document hardly mentions the "environment" at all. I suppose the authors just shrugged that off as "someone else's problem". Yet another opportunity missed for "clear guidance", then.

But yes, maybe all loan equipment should be Class II. Or perhaps a current (and favourable) EICR should be a pre-condition to loaning out the kit. It could be on the tick sheet that Glyn mentions at the OP. That would certainly wake a few folk up a bit.

As well as Ian's socket tester, of course. Another tick.

A good website summary and a big shout out to Mike for his points especially that rental properties should have an installation test certificate that is less than 5 years old.
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