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Detection rating for a user (surgeon) related failure mode in DFMEA

#1
Hi Guys
I have a question about detection rating for a user related failure mode in DFMEA.
This failure happens if the surgeon is not following the instructions provide in 'info for use'.

I could not find any relevant thread so am posting here. Let me know if this thread is not appropriate.
Here is the scenario...
The product is a medical device (For reference the severity rating is 9 and occurrence rating is 4 based on actual complaints received.
The only controls we have in place are the instructions about the following in 'information for Use':
1. what sort of experience the surgeon should have.
2. what should be done by the physician during the operation to avoid this failure mode.

What sort of detection rating should be given to these type of controls.

The detection rating table which we have is not very helpful.

Thanks

Desikiwi
 

GRP

Involved In Discussions
#2
Hi Guys
I have a question about detection rating for a user related failure mode in DFMEA.
This failure happens if the surgeon is not following the instructions provide in 'info for use'.

I could not find any relevant thread so am posting here. Let me know if this thread is not appropriate.
Here is the scenario...
The product is a medical device (For reference the severity rating is 9 and occurrence rating is 4 based on actual complaints received.
The only controls we have in place are the instructions about the following in 'information for Use':
1. what sort of experience the surgeon should have.
2. what should be done by the physician during the operation to avoid this failure mode.

What sort of detection rating should be given to these type of controls.

The detection rating table which we have is not very helpful.

Thanks

Desikiwi
Medical is not my field, but I see you could check the Hazard Analysis in ISO14971 Medical devices -- Application of risk management to medical devices.

At any rate, and in general terms when dealing with FMEA, detection rankings are relative entries in a table you yourself can build or adapt. The extremes are obviously something like detection ensured and no detection. If you already have knowledge from best practices in your industry or if you can benchmark from applicable fmeas, decide how many steps to use between extremes. In the automotive industry it is common to use 10 steps. Although you will find sources recommending as few as possible, say 5.

How does this detection compare with other detections given in the fmea? It is very important to rank your failure modes consistently. The numbers will not point to any objective quantity, but will help designers to prioritize issues.

Until someone in the Cove with medical experience jumps in, I can only offer for you to share your detection rating table and compare concepts with reputable automotive sources.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#3
Why is the surgeon not following the IFU? Overlooked? Or the device is being used off label? (foreseeable misuse?)

It's hard to say much about the assignments of risk without the tables to evaluate. If your table descriptions aren't operational enough, then you might need to recreate better definitions of risk and re-estimate the risk values that you have assigned. As GRP notes, you are after reasonable continuity throughout the exercise. In my risk documents, I like to list all the assumptions that the team operated on for future reference. Details on how you arrived at a definition should be recorded as well (especially where things aren't as obvious; in between the extremes so-to-speak). Start with the AIAG definitions and tailor to suite your business and perhaps the design.

Generally speaking, clinical personnel are better trained and educated (physicians/surgeons). But perhaps your failure mode has nothing to do with mental acuity and is more related to other limitations (sight, sound, physical ability, etc.). What I'm saying is that their ability to read and understand your IFU may not factor much into avoiding the failure mode. Keep that in mind if that's the case. Leverage standards that are available to you (e.g., Human Factors). You may find a golden nugget to solve some problems/answer questions. And leverage you Clinical personnel; they should be able to render reasonable explanations on mitigations presented.

Come back to us if you have more questions. Good luck!
 
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