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In the UK you can refer to section 3.4 of the MHRA guidance on managing medical devices:

https://www.gov.uk/government/publications/managing-medical-devices

Most medical device instructions for use (IFU) will state modifications are not allowed and that only accessories that are approved should be used with the device.

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Super Hero
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I had wondered whether that was going to be the source you offered, Mike.

All in all, yet another weak official (UK Government sponsored) document in my opinion. I can honestly say I have seen many better Policies and Procedures developed by in-house biomed departments.

I somehow doubt that those (or the person) drafting Section 3.4 had the securing of mains cables in mind. No doubt the same may be said about manufacturers' "IFUs".

But on a positive note, Section 5.3 is more to my liking.

Lastly, I wonder how many Trusts have appointed a Medical Device Safety Officer (MDSO) (see Section 2.1) ... in fact, it would be very interesting to learn how many Trusts follow these "guidance" documents at all.


If you don't inspect ... don't expect.
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Master
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It should also be reminded that you should follow IEC 60601-1 when considering any modifications.

Clause 8.11.3.5 - Cord Anchorage would seem to be appropriate. A p-clip may not meet the a) indent and the screw used to fix should not have any other function to meet the d) indent. If the power inlet plug is the means of disconnection then blocking this without updated instructions for use would be an issue. Interestingly as the device must be tested with the manufacturer using a different cord may be a breach of the certification!

The requirements of clause 8.11.3.6 - Cord guards must also be followed.

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Super Hero
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I would argue that all that (and, indeed, most if not all of 60601-1) is a document aimed at equipment designers and manufacturers. In short:- "type testing". Even the section headed "Repairs and modifications" (5.6) talks about "the testing laboratory" ... implying an agreed modification carried out during testing to achieve a "pass" next time (and then carried forward into production). Obviously, all that is done before the equipment is released for sale.

Brief history lesson (off the top of my head):- ever since the days of HTM-8 (...then BS-5724, then striding onward into international waters) biomed engineers and technicians (aka maintainers of in-service medical equipment) have felt the need to pick out bits and pieces from type testing documents in order to develop strategies applicable to routine in-service work, with great emphasis on electrical safety testing. To my mind, very little of these efforts are applicable to everyday repair and maintenance activities.

Once equipment has been through the process of accreditation (that is, passed the "type tests", and allowed onto the market), and subsequently purchased for use by qualified bodies (that is, the medical professions), then responsibility within the law (for example, the Electricity at Work Regulations (EWR) and the Health and Safety at Work etc. Act (HASAWA)) is carried by the owner (eg:- Hospital Trust). Within the confines of the law - that is, Common Law - the owners of equipment (any equipment I would say) can do anything they like with it.

In a well managed situation, the owners (Trust boards, or whomever) may delegate certain tasks down the chain ... repair and maintenance activities fall to the biomeds, for example. But Senior Management still carries the can if or when things go wrong (that's one of the reasons they are paid so well). That's because, they - the Corporate Body - are still the owners of the equipment; not the biomeds, nurses, nor anyone else. And that includes, of course, the manufacturers.

So, if Senior Management is kept aware of what their foot soldiers are doing ... be it affixing P-clips or any other sensible in-service procedure aimed at preserving the assets of the organisation, and keeping them available for their intended purpose, then so be it. If they are kept abreast of what is going on (repair and maintenance practices), and don't object to any of it, then we must assume they are happy with the situation ... especially if the kit is continually being kept safely in the hands of the clinical users.

This is where the well known attribute of the seasoned biomed comes into play:- CYA.

1) Policies and Procedures (reviewed at least annually)
2) Risk Assessments (especially for "controversial" issues)

Both should be and submitted "up the chain" for endorsement (agreement, or not) ... they (Senior Management) must never be able to say "ah, but we didn't know".

PS: for "cord", read "cable" (we are British, you know).


If you don't inspect ... don't expect.
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Adept
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Got on and do what is right most of regulations are guidance anyway.

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Super Hero
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Yes; that's my main point (in a nut shell).


If you don't inspect ... don't expect.
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Master
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People get away with breaking the law all the time (e.g., speeding). You just have to be prepared to defend yourself if you do find yourself in court, as they will use failure to follow "guidance" and "regulations" to prosecute you!

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Super Hero
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It would not be me, but rather the Trust CEO (or whomever) who would be in the dock.

But what would they be charged with?

"...in that they, at such-and-such a hospital on such-and-such a date, did wilfully affix a P-clip..."

Anyway, as I have already tried to spell out, I would use in my defence yet another "guidance" document:- my own carefully crafted Policies and Procedures duly signed off by the Trust Board.


If you don't inspect ... don't expect.
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Perhaps you could be charged with doing your best!

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