Risk Analysis of a "Medical System" according to ISO 14971

[cyril john]

Hi all, I am new on this forum so I am eagerly waiting for your suggestions.

-Can some one help clarify how to do a risk analysis for a "medical System" (in this case, we have a dialysis machine, connected to non-medical devices like disposable blood lines, plastic connectors, an IT network)

-The risk analysis for each product ( dialysis machine , disposable blood lines) is done separately, that is by their respective producers.

-How can we do a risk analysis of the assembled MEDICAL SYSTEM, permits us to:

• manage change (i.e to systematically analyse the effect of a change in one product on other products and on the entire system);
• to avoid double assessment of the same hazards.

according to the norm ISO 14971 or En 60601-1
Thanks,

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[yodon]

Well, I'll toss out something to maybe spur the discussion along...

I guess I'm having trouble understanding your issue. Are you saying that the "system" has different risks than the summation of risks of all components? What other kind of hazards / risks are there with the system? Clearly you'll need to have some system-level view of all the risks.

Would doing something like a use / application perspective risk analysis cover your concerns?

 

[abigailt]

We recently received training on ISO14971 and it became apparent that we were missing a trick in that the Annexes are very useful.

Annex C in particular can be used to ask the right questions based on the 'system' - it may then be relevant to reference the risks from a particular component or it may be necessary to analyse the risk of the system as a whole.

Annex D gives good guidance on Risk concepts and analysis, evaluation etc

 

[cyril john]

Hi all, thanks so far for your replies.

Annex C is really helpful in identifying risks which could arise in the system. Prior to this, I didn´t realize it could be used for "Systems".(thanks abigailt)

And as for the extra explanations requested, I have attached a photo which represents the "system".

Actually, all the possible hazards and risks are already known. And the corresponding risk control measures are also known. But this assessment has been done separately:

• for the entire dialysis Machine, (by the producers of the dialysis machine)
• for each of the other components (by the producers of each component).

Yet the real problem is the level of the interface. Having assembled the "Medical System" , We want to take each risk which exist at the interface

- verify the correct implementation of each risk control measure.

A model like that used in figure H.2, Annex H of IEC 60601-1 3rd Edition, could be very helpful. This model is however for a PEMS and not for "Medical Systems"

Hope this sheds more light on the problem

thanks

 

[Pads38]

As many of the risks involved are related to the use of the system (incorrect connections, interface misunderstood, use errors, deliberate misuse etc etc) you may want to consider the usability standard IEC 62366.

It also has very useful informative annexes (E - H).