Risk Management in the Medical Device Industry

racglobal

Involved In Discussions
#1
Hi everyone,

Has anyone had experience with risk management that's not based on 14971? It assumes reliability, but realistically, risk analysis for complex devices has now taken on many other techniques for examples from systems engineering. Can these models be applied to do risk analysis as opposed to a framework based on 14971? Thanks.
 
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Marcelo

Inactive Registered Visitor
#2
Not sure what you mean, do you mean something like, let's say, STAMP?

Please note that things like STAMP are, in their most basic view, accident causation models, not risk management frameworks.


ISO 14971 is basically a standard with very high level requirements, based on the practices of risk m management found in the engineering risk management field. It's so high level, in my opinion, that It creates problem. On the other hand, by being high level, it accepts basically any framework for risk management that you can found in the engineering risk management literature (including all the frameworks used in systems engineering that I know). For example, it does not require that you define your accident causation model (although you do need to do so to effectively implement ISO 14971).
 

racglobal

Involved In Discussions
#3
Hi yes, a safety analysis such as STAMP. My question is how does this method fit into the 14971 framework? ISO 14971 requires that we estimate risk, which is not part of the STAMP framework. Much more than a hazard analysis technique, it is really a different framework (accident-causality as opposed to a risk management framework, as you pointed out). Two parts to my inquiry:

1- What would happen if we replace 14971 framework with the STAMP framework? STAMP also uses different terminology (e.g. "loss" as opposed to harm)
2- If we use 14971 as the RM framework, are we simply replacing the traditional hazard analysis techniques with STAMP, assuming STAMP is a hazard analysis technique rather than a new framework.

I've Googled STAMP and 14971. However, while some see it as a hazard analysis technique compatible within the 14971 framework. Some see it as a new framework that could replace 14971 in premarket submissions. Any clarification from the expert community would be appreciated.
 

indubioush

Quite Involved in Discussions
#4
I have not heard of STAMP before, but it seems like it is a method for determining hazards and hazardous situations. Any method of determining hazards and hazardous situations can be used with ISO 14971. But no matter what method you use, you are still required to follow ISO 14971 if you are a medical device company. Determination of hazardous situations is only one part of risk management. There is so much more than that, and ISO 14971 is the required framework.

Also, I would not change "harm" to "loss." If you are medical device company, you are concerned with patient harm.
 

Marcelo

Inactive Registered Visitor
#5
Much more than a hazard analysis technique, it is really a different framework (accident-causality as opposed to a risk management framework, as you pointed out). Two parts to my inquiry:
I don't think I was clear enough, and I'm not sure what is your experience with these things, but:
- Accident causation models are required in any risk management process (you need to define which one you will use)
- ISO 14971 does not mention accident causation models, but it does not mean that you do not need to choose one model
- ISO 14971 "seems" to use a simple linear sequential model, but it's not true. The way it's written is required to comply with ISO/IEC Directives (which requires clauses in sequence and other things), but ISO 14971 is high-level enough to accommodate any accident causation models, including the complex linear or, more recently, non-linear models. In fact, one of the sources of ISO 14971 is James Reason's model, which is non-linear.
- STAMP is basically one of these accident causation models, a non-linear one. As I mentioned before, it can clearly be used to comply with ISO 14971 (but you will need to make some adjustments, as is true with any accident causation model you choose to use).
 
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