ISO 14971 Clause 7 - Evaluation of Overall Residual Risk Acceptability

[Sam Lazzara]

I am interested to learn what others are doing to conform with ISO 14971 clause 7 for "Evaluation of overall residual risk acceptability".

In my experience, some firms are looking to see if each individual Residual Risk Index meets the individual risk acceptance criteria, and if so then they conclude that the overall residual risk is acceptable. The standard demands more than this. It requires overall acceptability to be judged based on criteria defined in the risk management plan. It refers to informative Annex D.7 for guidance.

Any ideas for the criteria that can be evaluated to assess overall residual risk acceptability, other than those give in D.7?

Alternatively, if anyone can further interpret/explain the D.7 guidance, that would be great.

Are there any references that shed more light on this.

 

[Stijloor]

A Quick Bump!

Can someone help Sam?

Thank you very much!!

 

[sagai]

I am 1oo% with your observation.

I tend to say most of the companies I have seen already including couple of the most recognized brands, are utterly ignoring or let me rephrase ... experiencing difficulties to recognize the purpose of the overall residual risk evaluation and yes, most of them in practice are using some mathematical method to reach the conclusion, including but not limited to use RPMs and other metrics to pretend, mathematical and statistical calculation can substitute ... the common sense!

The way I have experienced and I think one of the way could be okay for this purpose is, as part of the overall residual risk evaluation the clinic fellow or a team of experts having knowledge, education and experience on medical disciplines looks into all of the results of the risk management process and takes a holistic view of the final hazard landscape, including but not limited to the mitigations, result of the internal and external testing and also to the procedures they were followed and meditating till coming to the conclusion whether or not the result of the research and development deemed to be safe and effective.
And then the jedi committee can come to make the final design review.

Recently I am trying to extend this final meditation to incorporate somehow the review of recalls and MDRs for similar products in order to make sure the best we can has done.

Cheers!

 

[Ronen E]

I am 1oo% with your observation.

I tend to say most of the companies I have seen already including couple of the most recognized brands, are utterly ignoring or let me rephrase ... experiencing difficulties to recognize the purpose of the overall residual risk evaluation and yes, most of them in practice are using some mathematical method to reach the conclusion, including but not limited to use RPMs and other metrics to pretend, mathematical and statistical calculation can substitute ... the common sense!

The way I have experienced and I think one of the way could be okay for this purpose is, as part of the overall residual risk evaluation the clinic fellow or a team of experts having knowledge, education and experience on medical disciplines looks into all of the results of the risk management process and takes a holistic view of the final hazard landscape, including but not limited to the mitigations, result of the internal and external testing and also to the procedures they were followed and meditating till coming to the conclusion whether or not the result of the research and development deemed to be safe and effective.
And then the jedi committee can come to make the final design review.

Recently I am trying to extend this final meditation to incorporate somehow the review of recalls and MDRs for similar products in order to make sure the best we can has done.

Cheers!

This would be a perfect world scenario...

Regularly following FDA's Medwatch, class I recall notices, published warning letters etc. gives me a feeling that the above is not (and won't be?) widely practised

Edit: It seems that international medical devices regulation is taking a course that doesn't support this approach, in recent years (or since ever?...) Most of the written regulation and published guidance I know require clear (documented) criteria for making such decisions, and don't support this kind of "holistic meditation". It's quite likely IMO that in the rare occurrence of such "Jedi council" convening and coming to a well-worked consensus, regulators will require their considerations and rationalisations documented in an elaborated way, demonstrating that their final decision is in line with the (elaborately documented...) predetermined acceptance criteria... which is IMO near impossible, especially when the expert panel consists mainly of highly knowledgeable clinicians rather than regulatory technocrats like us