Terms in accompanying documents to conform to IEC 60601-1-11

M

mr.mike

#1
Hi Everyone,

Planning a draft of the instructions for use for a ME equipment used in the home.

As such, we'd like to comply with the home healthcare standard IEC 60601-1-11.

Having some difficulty. In particular, with the following requirement:
"...usability of identification, marking and accompanying documents...shall be evaluated based on an operator profile that includes a maximum of eight years education." (underline added)

Anyone have any experience as to how this is evaluated in practice?
Presumably there are exceptions, namely with regards to technical specifications and contraindications?

The contraindications, in particular, list a bunch of conditions that most people, let alone with a "maximum of eight years education" would recognize.
...but the contraindications must be stated. No way around that....

Any input?
Thanks,
MM.
 
Elsmar Forum Sponsor
#2
Re: Terms in accompanying documents to comform to IEC 60601-1-11

Hi Mike,

I don't have direct experience but.. 8 years education suggests a child aged 12 or 13. Searching wikipedia for 'Readability Test' gives lots of examples.

http://en.wikipedia.org/wiki/Readability_test

And, if I remember correctly, there is a test included in the tools of MS Office.

For the contraindications - I suspect that many can be 'de-jargoned'. But, can you divide the contraindications into ones that would apply at home and ones that would only happen in a clinical environment? There is little need to warn a home user about MRI risks or electro-surgery risks.
 
M

mr.mike

#3
Re: Terms in accompanying documents to comform to IEC 60601-1-11

Yes, the standard itself has a bunch of suggestions for software tools to gauge and index readability.

My concern is how to conform to "eight years of education", when some of the content will definitely throw the aforementioned software off the scale..

For example: "sclerosis" - I guess you could say "hardening of tissue", but in terms of stating contraindications, it'd be a bad idea to deviate from specific conditions...

Even a word like "rehabilitation" throws those gauges off as they look for not only words per sentence, but syllables per word...

So the issue remains: these are medical devices, with labeling requirements that often can't be expressed at a grade-eight level.
Sure, we'll do all we can to make the "meat" of the operating instructions as accessible as possible, but as far as the entire document being understood by a 12-year-old...that's a bit much to ask...
 
M

mr.mike

#4
Re: Terms in accompanying documents to comform to IEC 60601-1-11

I guess, the bottom-line question is this:

Is it permissible to:

1) Write the actual "operating" (e.g. setup, use, maintenance..etc.) instructions at a "lay person" (max eighth-grade) level, and

2) Have everything else in the accompanying documents (contraindications, warnings, technical description...etc.) deviate from the above as necessary,

...and still comply with IEC 60601-1-11?

Anyone have any experience getting their accompanying documents examined for IEC 60601-1-11 compliance?
 

Peter Selvey

Staff member
Super Moderator
#5
Re: Terms in accompanying documents to comform to IEC 60601-1-11

I think this is one of these classic cases where real risk management is useful (rather than the one line approach encouraged by ISO 14971).

Realistically, many warnings (including contraindications) are there as a kind of legal firewall, and careful analysis will find other reasons why the warning itself is not really important. But there are also times when careful analysis shows that the warning is really important.

With each contraindication, you would need about a page or so summarizing research on the issue, such as probability of the condition existing, the effects if the device is used anyway, and if this analysis shows the contraindication is really important, discussion on effective methods to warn the patient.

For example, a home use NIBP monitor might have warning that the measurements may not be accurate for patients with sclerosis. Good risk management will quantify the extent of inaccuracy, the proportion of patients (users) with sclerosis, the effects of inaccurate measurement. Having quantified these issues you can then proceed discuss whether a simple contraindication would be effective in controlling this risk. If not, you would have to start thinking about other methods, or describe why the residual risk (use against indication) is acceptable.

These are things which cannot be covered in a single line in the risk management table.
 
M

mr.mike

#6
Re: Terms in accompanying documents to comform to IEC 60601-1-11

Thanks for the reply Peter. I agree.

...but my inquiry has really to do with the language in the accompanying product documents (e.g. User Manual), not with risk management.

cheers!
 

Peter Selvey

Staff member
Super Moderator
#7
Re: Terms in accompanying documents to comform to IEC 60601-1-11

Yes, I understand, the basic point here is, is it justified to ignore the requirements in IEC 60601-1-11. I think the answer will come from a reasonable analysis of the individual contraindication (probably using the words "risk management" was a mistake on my part).

In other words, we cannot answer in general, it will depend on the particular situation.

In the background though, it is likely that this will not be the only point where -1-11 requirements will conflict. There are many IFU requirements in the general standard which would be difficult to handle with 8 yo reading level. So it is clear that at some point something has to give in terms of literal compliance with standards. There are also some other questionable requirements in -1-11. It is a new standard, so probably we will see these issues bubble up to the committee level eventually.

Upshot is, don't be afraid to be a little bit flexible with standards (especially in cases like this), but just be sure of your rationale before proceeding, and document it as well.
 
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