ISO Registrars/CBs citing for use of "Detection" in Risk Management

Marcelo

Inactive Registered Visitor
#11
This does of course raise the possibility of a scenario in which a higher risk design approach might be preferable to a lower risk one because the higher risk approach has much more detectability, and a present professional user would mitigate the harm. I would suggest though that in that scenario, the analyzed risk remains higher, and acceptability of the detectability-based design approach is a deviation from the normal procedure and would require documentation of why it can and should be accepted.
If the risk remains higher but still acceptable, that in principle would be no problem to ISO 14971.

But please note that, in the case of the user (being it professional or not), you do not to go thru the usability engineering process to make sure that he can do what is expected. The problem is blindly relying on the professional user - the problem might be with the device design, which induces use error.
 
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M

MIREGMGR

#12
Re: ISO Notified Body citing for use of "Detection" in Risk Management

US FDA doesn't (yet?) explicitly acknowledge a usability engineering process as a requisite part of the design process, so from their perspective such issues must be integrated into risk analysis (which is explicitly required) if they have risk ramifications.
 

Marcelo

Inactive Registered Visitor
#13
Re: ISO Notified Body citing for use of "Detection" in Risk Management

US FDA doesn't (yet?) explicitly recognize a usability engineering process as a requisite part of the design process, so from their perspective such issues must be integrated into risk analysis (which is explicitly required) if they have risk ramifications.
The idea is the same, because the usability engineering process is exists only to deal with the "usability hazards" that each devices has.

Even IEC 62366 is integrated into risk management (and yes, it´s is this way in part because FDA sees it this way).

Update: there´s a never-ending discussion regarding usability and human factors in the US, just as a reminder :)
 
M

MIREGMGR

#14
Re: ISO Notified Body citing for use of "Detection" in Risk Management

One of the real main problems with detectability and why it does not fit into ISO 14971: essential principles require that risk control measures are defined in order, 1 - inherit safety, 2 - protective measures, 3 - information for safety.
This illustrates yet another problem with international use of standards: the need in this example to reference an EU-specific requirement to understand the supposedly-freestanding-international-standard's drafters' intent.
 

Marcelo

Inactive Registered Visitor
#15
Re: ISO Notified Body citing for use of "Detection" in Risk Management

This illustrates yet another problem with international use of standards: the need in this example to reference an EU-specific requirement to understand the supposedly-freestanding-international-standard's drafters' intent.
Not EU, but GHTF :)
 

Sam Lazzara

Trusted Information Resource
#16
Re: ISO Notified Body citing for use of "Detection" in Risk Management

Several years ago my Notified Body at the time explained their concern regarding having Detectability as a separate factor. I personally never liked having Detectability as a separate factor since I think there can be confusion between in-house detection (before shipment of the device) and user detection (before or during use). However, I still think it is important to somehow account for detection so I have included it in my definition for Probability (see below).

Probability (P): The likelihood of occurrence of harm due to a particular Potential Cause based on relevant historical data, analytical or simulation techniques, and expert judgment. Estimated P levels take into the account the likelihood of detection before shipment or by the user before product use. Five P levels are defined as follows....
 
G

g frias

#17
Thank you all for the lively discussion and input!

Sam - Our retooling of the risk management tool took a similar approach to yours.

We ended up maintaining use of FMEA (including detection) for process but "detection" was explicitly defined as "in process" to account for things like validated vision systems that could detect a failure mode and kick out the defective component.

So it sounds like this is the way in which industry is moving and I agree with you Bev D., I like it as well.
 
G

g frias

#18
Regarding the OP's issue, we've had this specific discussion with both our NB and our Authorized Representative. We initiated the discussion with our NB, who accepted our approach after discussion. Our Authorized Representative raised the point themselves, but again accepted our approach after discussion.

It may have been relevant in both cases that they recognize that we must comply to both the US FDA's and the EU's expectations.
Thanks Miregmgr. Can you expand on this? What was the approach you were using? Standard FMEA, including detection? Was the use of detection the issue?
 
M

MIREGMGR

#19
Thanks Miregmgr. Can you expand on this? What was the approach you were using? Standard FMEA, including detection? Was the use of detection the issue?
We start with an engineering FMEA, a regulatory analysis and a clinical issues analysis, then mash everything together and remove the issues that don't have a potential to result in relevant harm. I don't know what to call it.

Detection was brought up by the NB and the Auth Rep because it appears in our quantitative analysis documents and they wanted to discuss why, in relation to the wording of the standard. As noted above, because user error is the statistically most common issue for some of our physically simple non-active products and detection of user error by the user is the statistically most common mitigation, we regard it as essential that our risk process take user error detectability into quantitative account.

(This explanation of course makes it sound as if we should re-design to eliminate user error. That's been tried in the past...the market has exhibited zero interest in product re-designs that have the necessarily greater cost and complexity to substitute design features for user error detection. Cost, in and of itself, is a key product feature, since at the micro level it determines profit and at the macro level it determines how much healthcare society can afford to provide.)
 

Marcelo

Inactive Registered Visitor
#20
As noted above, because user error is the statistically most common issue for some of our physically simple non-active products and detection of user error by the user is the statistically most common mitigation, we regard it as essential that our risk process take user error detectability into quantitative account.
Just curious, have you evaluated the devices human factors/usability to make sure that the devices does not induce the user to make a mistake?

I'm just asking because this seems like the type of historical problem related to human/factors usability, that prompted the change of the term "user error" to "use error".
 
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