FoGia

Involved In Discussions
#1
Hello,


IMDRF opened a consultation regarding annex E & F on their draft guidance related to health effects.
According to their guidance, adverse events ought to be classified following their clinical signs, symptoms and conditions on one hand and following their health impact on the other hand.
http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-terminologies-aer-n43-180712.pdf

This classification is leaving me somewhat puzzled, I am wondering how this classification could be reconciled with a risk management system such as described in ISO 14971.
In Annex F there are even some items that haven't much to do with impact on health, such as 'prolonged surgery' or 'modified surgery'.

An option could be to describe harms as a combination of at least one item per category and use the item from Annex F to assess the reportability of the harm following local requirements.


What do you think?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
re: IMDRF opened a Consultation on Annex E & F and the link to ISO 14971

Not sure I understand what the problem is.

ISO 14971 requires a risk management process, but it is very high level on most of the requirements. For example, it leaves categorization of harms and others to the manufacturer. In principle, anything that makes sense can be used, including everything that is defined in the IMDRF document (which is in fact a kind of revision of ISO 19218, which is not new).
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
re: IMDRF opened a Consultation on Annex E & F and the link to ISO 14971

An additional comment - some people (myself included) have been using ISO 19218 as one of the basis for categorization of harms for some time - there will be a need to update when the IMDRF finish their work, but as I mentioned before, the concept is the same and is already under ISO 14971 (which is why I did not understand the "reconciled"in the original post).

On the other hand, if you look at the content of Annex E and F, you will see that it is really granular (in particular Annex E), and you don't need to go into that much granularity into your RM process - you may if you want, but I think it's too much work. The easiest way would be to group the granular definition into groups, such as the one in Annex F (which deals with the magnitude of the harm, in ISO 14971 terms).
 

FoGia

Involved In Discussions
#4
Thank you Marcelo for your replies.

I am not familiar with ISO 19218, hence my question. I understand that I need to learn more on the topic of RM.
The problem that I have with annex F is that some items may very well lead to no impact at all on the health of the patient, a 'modified surgical procedure' doesn't necessarily mean a procedure with worse outcome, yet the wording 'health impact' sounds closer to the notion of severity than harm(you mention 'magnitude' in your post, I guess this is another word to describe severity as mentioned in D.3.4.2 in ISO 14971:2009). Or am I misunderstanding something?
 

Top Bottom