Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's

Ronen E

Problem Solver
Moderator
However, what Iso 14971 mentions )I don't remember where right now) is that, if the abnormal use is a common medical practice, you should probably identify it as misuse, because everyone uses the device that way...

1. ISO 14971 doesn't mention "abnormal use". Maybe it's discussed under another term (I can't remember now either).

2. That approach doesn't make much sense to me because it undermines the concept of contraindications. Basically what you wrote (or referred to) means that going against a printed contraindication (=abnormal use) should be considered "a use error" simply because that contraindication is absent in other (similar) devices' IFU or simply because a lot of users use that type of device off-label.
 
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Ronen E

Problem Solver
Moderator
"Risk-based thinking" does not exist (you really can't find any mention of this in a consistent way in the literature or risk management experience). The "term" was recently created to try to convey an idea that is not really correct.

It would help the discussion if you wrote what exactly is this idea that you claim is not really correct.

I still perceive "risk-based thinking" as a formalisation of (or as you call it, a systematic approach to) survival-induced common sense.
 

Marcelo

Inactive Registered Visitor
1. ISO 14971 doesn'r mention "abnormal use". Maybe it's discussed under another term (I acn't remember now either).

You are right, the term abnormal use was created for IEC 62366 which was created little after the 2007 revision of 14971.

2. That approach doesn't make much sense to me because it undermines the concept of contraindications. Basically what you wrote (or referred to) means that going against a printed contraindication (=abnormal use) should be considered "a use error" simply because that contraindication is absent in other (similar) devices' IFU or simply because a lot of users use that type of device off-label.

What I tried to say is that the design process could have problems, in particular related to device use and user research (as part of a human factors engineering process) and, although the manufacturer deemed the use off-label, it was not in fact off-label, the problem is that the manufacturer did not do a good use research and did not noticed that everyone used the device in a specific way. I've seen this problem happen sometime.

I really do not remember where this is written, maybe in a discussion on IEC 62366 that was not put into the final standard....really do not remember.
 

Marcelo

Inactive Registered Visitor
It would help the discussion if you wrote what exactly is this idea that you claim is not really correct.

I'm not saying it's correct or incorrect, I'm only saying that this "idea" or "term"does not have a historical background. The term used in ISO 9001 has been created from scratch to try too convey a concept, but if you look a the way the term has been used, there's no consistent definition of use of it to mean anything in particular.

I still perceive "risk-based thinking" as a formalisation of (or as you call it, a systematic approach to) survival-induced common sense.

Well, risk management - the formal, historical process - would be a systematic approach to common sense.

"Risk-based thinking", as I mentioned, I don't now what it means.
 
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blah01

Involved In Discussions
Hopefully my last question on this...I believe I read somewhere that the US FDA will be "adopting" ISO 14971...I put "adopting" in quotes on purpose because I find it a bit vague, meaning that the QSR already lists ISO 14971 as a reference, but I'm not sure if it will impose ISO 14971 as a requirement. Does anyone have any insights into this?

Thanks.
 

Marcelo

Inactive Registered Visitor
Hopefully my last question on this...I believe I read somewhere that the US FDA will be "adopting" ISO 14971...I put "adopting" in quotes on purpose because I find it a bit vague, meaning that the QSR already lists ISO 14971 as a reference, but I'm not sure if it will impose ISO 14971 as a requirement. Does anyone have any insights into this?

Standards are not mandatory for the FDA. In fact, standards by definition are voluntary, and most countries maintain that status quo. Only some countries (Brazil, China and Korea are the ones I know) require mandatory use of standards.

What happens is that you need to fulfill mandatory regulatory requirements, and standards are usually the best way to show compliance to specific regulatory requirements.

Back to the FDA, the agency has a policy on the use of standards. This link - (broken link removed) - explains it all (you need to read the guidance linked in this page).
 

Ronen E

Problem Solver
Moderator
What I tried to say is that the design process could have problems, in particular related to device use and user research (as part of a human factors engineering process) and, although the manufacturer deemed the use off-label, it was not in fact off-label, the problem is that the manufacturer did not do a good use research and did not noticed that everyone used the device in a specific way. I've seen this problem happen sometime.

I still think that going against an explicit contraindication should be considered abnormal use (provided that there's no practical way to prevent that specific use through actual device design), regardless of what users are commonly doing. It might not be the best design practice, but it's consistent with the definition of the term "abnormal use" as provided in IEC 62366.
 

Ronen E

Problem Solver
Moderator
Well, risk management - the formal, historical process - would be a systematic approach to common sense.

"Risk-based thinking", as I mentioned, I don't now what it means.

In my understanding it means applying risk management concepts in whatever you do or think about. The only difference from just applying common sense is that common sense is usually applied informally and sometimes even subconsciously, and risk-based thinking is aimed at making it a concious, formal process (albeit not always fully documented).

That's just my understanding. What the standard authors intended I really do not know.
 
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Marcelo

Inactive Registered Visitor
I still think that going against an explicit contraindication should be considered abnormal use

I agree, it's still abnormal use from the standpoint of the application of regulatory requirements regarding label. But depending on the case, I would not consider it consistent with the IEC 62366 definition.

Another example, lets say the device has a control which uses the green colored to identify "stop"and red color to identify "go on". It's implemented on the device this way and described in the instruction for use this way.

But it is not right from the standpoint of human factors because it's not according to human behavior (and established "standards"of color). People will use it incorrectly because of bad design. It's still "abnormal use" from a regulatory standpoint but it's not "beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the MANUFACTURER".
 

Marcelo

Inactive Registered Visitor
That's just my understanding.

And that's what I'm concerned. Everyone will have it's own interpretation because there's no formal definition and understanding now, and because there's has never been a formal definition and understanding in the past.
 
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