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Risk Benefit Analysis - ISO 14971:2012 Requirements
UL - Underwriters Laboratories - Health Sciences
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
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iso 14971 - medical device risk management, risk management and analysis
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  Post Number #17  
Old 11th August 2017, 11:09 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
Re: Risk Benefit Analysis - ISO 14971:2012 Requirements

Quote:
In Reply to Parent Post by Ronen E View Post

I think that the definition offered in the 1st paragraph is not complete. It's like saying that risk=potential harm, which is inaccurate in my opinion. It ignores the probability aspect of the risk, and once again treats risk as an object rather than as a state.

The same applies to benefit, because benefits (especially clinical ones) also have a probabilistic nature. Attaining a given benefit is usually not 100% guaranteed. So, the presence of a benefit is also a (probabilistic) state, and thus they can be compared.
You are right, I did not want to give a complete definition (which is rather difficult, in fact) but to give another general way of looking at risk, and trying to point out that we need to focus on what might happen to the patient/user/etc.

As you know from discussion here and in practice, a lot of people still think that they should stop analyzing when they identify the device failure.

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  Post Number #18  
Old 11th August 2017, 11:14 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: Risk Benefit Analysis - ISO 14971:2012 Requirements

Quote:
In Reply to Parent Post by Ronen E View Post

I would say that benefit is exactly the negative of risk (and vice versa of course).
I don't think I agree with this, but I would have to elaborate some more and I'm already falling sleep here :-(, maybe tomorrow.
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  Post Number #19  
Old 11th August 2017, 11:52 PM
Ronen E

 
 
Total Posts: 3,379
Re: Risk Benefit Analysis - ISO 14971:2012 Requirements

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

the regulations, such as the MDD/MDR, require a risk/benefit analysis, not a residual risk/benefit analysis.
While you are technically right, I think that the intent was to address residual risks in the RBA. There is no point in considering the current state of expected benefits ("benefit" in short) against risks that exited earlier but are not real any more. What's relevant for the RBA (id we look at it not as a purely theoretical exercise but as something meaningful and realistic) is considering the current benefit against the current (=residual) risk.

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

all risks, including residuals risks, need to be taken into consideration.

In particular, there are risks that may be acceptable without mitigation, for example. By definition, they are risks, but not residual risks.
I think that this is where we diverge. In my interpretation "residual risks" are the current ones, whether any mitigation means were applied or not. The "dry" definition says that residual risks are those that remain after mitigation means have been applied. "Mitigation means that have been applied" for a given risk may be an empty set, eg when there are no possible / practical mitigation means available, or - as you noted - when the risk is already deemed acceptable.

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

If we are following general risk management principles, such as the ones defined in ISO 14971, there are only three ways to mitigate risks - inherit safety, protective measures or information for safety. A clinical evaluation does not do any of the 3. It does help to get information so any of the 3 can be included or changed. But the information it gives in itself do not mitigate the risk.
The MDD says (ER 2):

Quote:
In selecting the most appropriate solutions [The solutions adopted by the manufacturer for the design and construction of the devices], the manufacturer must apply the following principles in the following order:

— eliminate or reduce risks as far as possible (inherently safe design and construction),

— where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,

— inform users of the residual risks due to any shortcomings of the protection measures adopted.
It speaks of the device's design and manufacture in general (in my interpretation first and foremost of the initial design), not specifically of risk mitigation. In my understanding risk mitigation is the attempt to bring risk (again, in my interpretation a perceived state, not an objective physical aspect ot reality) down, to at least an acceptable level. Following this line of thought, any means that can do it with confidence (including collection and analysis of new/existing information) should be considered mitigation means.

As to ISO 14971, I think that there is a wide consensus (probably including yourself) that it is currently worded in a flawed / problematic way, in various clauses. What I'm trying to do here is to offer a fresh perspective that might hopefully be of some utility in that standard's upcoming update (probably being a little naive here )
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