The Sequence of ISO 14971 Risk Analysis Activities

rothlis

Involved In Discussions
#11
in my opinion you could add a clause at the beginning of your RMF excluding all generic hazards addressed by 60601 (applicable parts) on the grounds that your device is tested and certified properly. then go on to analyse those "special" risks that are unique.
I agree with this, but unfortunately I've also seen this approach rejected by a reviewer. I think it's still worth a shot though, on the chance that you get a reviewer with common sense.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
I agree with this, but unfortunately I've also seen this approach rejected by a reviewer. I think it's still worth a shot though, on the chance that you get a reviewer with common sense.
Thanks for sharing your experience.

I'm not sure what was the review basis (e.g. 60601, 13485, 14971, USA regulation or other), but anyway I wouldn't accept any "rejection" without saying "Show me the 'Shall', please!..."

Reviewers shouldn't formally have the discretion to reject anything because "they feel like it".

Cheers,
Ronen.
 
K

kanwal

#13
The value of the two step risk analysis is in the following manner

Step 1 We undertake an analysis of the risks that exist in the design of the device per se, without any risk reduction. This step will also include some risks that may be introduced by the production process.

Step 1a We undertake measures to reduce risks identified in Step 1

Step 2 We undertake an assessment of the risks that remain or are introduced by the risk reduction measures introduced in the design and/or the production process.

These steps are important so as to have a logical and sequential process to conduct a detailed analysis.

Illustratively, a ground is introduced as a measure to reduce risk of shock in the first process. Hence we introduced a ground to mitigate this risk. In the second round, we have a new risk in that the ground can become defective, and we dealing with very high voltages, then we need to adopt secondary measures to reduce the risk of shock further. Please note we are now dealing with a different kind of risk than that in the first step. The risk in the first step was risk of electrical shock. In the second step, we are dealing with the risk of failure of the risk mitigation effort adopted as a consequence of analysis of step 1.

I have given a simplistic perspective.

The two step can give rise to the development of new class of medical devices, and can create new business opportunities. Illustratively, the Drug Eluting Stent.

The industry first introduced Bare Metal stents to treat blockages, but these resulted in the development of restonesis. Drug Eluting Stents were introduced to treat such residual risk.

May I add that residual risks are of two kinds

1. Risks that have not been eliminated by the risk mitigation efforts. These are allowed to remain based on the risk benefit analysis. The risk matrix in the second step will reference this risk benefit analysis.

2. Risks that are introduced as a result of the risk mitigation exercise. It is this kind of risk that is to be eliminated by the second step.
 
M

medical_eng

#14
Hi Everyone,

I like the suggestion in Ronen E's response of 25th October 2012 06:30 PM.

Thanks Ronen!
 

Ronen E

Problem Solver
Staff member
Moderator
#15
Hi Everyone,

I like the suggestion in Ronen E's response of 25th October 2012 06:30 PM.

Thanks Ronen!
You're welcome...

However, as far as I understand, the Cove presents dates and times adjusted to the time zone each of us is in, and since we are spread all around the globe the difference can be big (even different dates). I reckon the best way to associate a response with a certain post is by initiating the response using the "Quote" button.

Cheers,
Ronen.
 
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