Is Pain considered Harm in ISO 14971?

Mark Meer

Trusted Information Resource
#1
So, the definition of harm being:
"physical injury or damage to the health of people..."

Would unwanted temporary pain (albeit intense) be considered harm?

Strictly by the definition, I'd say no...

Curious what others think...
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Is Pain considered Harm?

So, the definition of harm being:
"physical injury or damage to the health of people..."

Would unwanted temporary pain (albeit intense) be considered harm?

Strictly by the definition, I'd say no...

Curious what others think...

For all practical purposes, it should be. You definitely want to evaluate the risk associated with causing pain, and mitigate it as warranted.
 

Mark Meer

Trusted Information Resource
#4
Re: Is Pain considered Harm?

For all practical purposes, it should be. You definitely want to evaluate the risk associated with causing pain, and mitigate it as warranted.
I agree that the potential to cause temporary unwanted pain should be considered and mitigated. This would be just good design practice...

...but strictly by ISO14971, it'd still say it's not harm.

...or is what you're suggesting is that pain can lead to a hazardous situation? e.g. "unexpected pain startles patient when they're carrying a hot drink"... so pain itself is not harm, but could lead to harm...
 
M

MIREGMGR

#5
Pain can cause harm to many bodily systems through disruption of functionality of the autonomic nervous system, various sectors of the brain, the cardiovascular system, and others. Pain can cause harmful chemical changes, stroke, heart attack, shock, broken bones and death.

In any case, your question really should be asked of a medically qualified person, not a bunch of regulators. We can agree or disagree with you as to what ISO 14971 says, but we can't authoritatively define patient harm. My guess is that any doctor would say significant pain causes harm, but a specialist in conditions that cause significant pain probably would know most authoritatively.
 

somashekar

Staff member
Super Moderator
#6
So, the definition of harm being:
"physical injury or damage to the health of people..."

Would unwanted temporary pain (albeit intense) be considered harm?

Strictly by the definition, I'd say no...

Curious what others think...
Pain is not a harm.
Pain is the consequence of a harm.
Next is the severity of such a consequence.
In the benefit estimation of the device, the effective output and the undesired output (Pain / Burn) must be compared.
Dettol protects, but burns the first few seconds when applied over an injury.
 
Last edited:

Pads38

Trusted Information Resource
#7
I would suggest that pain causes "...damage to the health of people...", so for 14971 considerations it should be considered "HARM".

The duration of any such pain is obviously significant.
 

somashekar

Staff member
Super Moderator
#8
Perhaps, due to damage, pain manifests. This pain may then cause some other damage... (Ex. Induce Fever)
 
Last edited:

Statistical Steven

Statistician
Staff member
Super Moderator
#9
So, the definition of harm being:
"physical injury or damage to the health of people..."

Would unwanted temporary pain (albeit intense) be considered harm?

Strictly by the definition, I'd say no...

Curious what others think...
Pain is a harm. The question is the SEVERITY of the harm. If it is temporary pain with no medical intervention (no aspirin) then might be minor. The hazardous situation that caused the pain is what is mitigated, not the harm.
 

Mark Meer

Trusted Information Resource
#10
So it seems to be different ways pain can be considered:

On the one hand not be considered harm:
(Jennifer Kirley) Since emedicinehealth defines pain as an unpleasant sensation, it seems fair "by the book" to say it's a symptom and not harm, which Merriam-Websters defines as physical or mental damage.
Or it can present a hazardous situation that leads to harm:
(MIREGMGR)Pain can cause harm to many bodily systems through disruption of functionality of the autonomic nervous system, various sectors of the brain, the cardiovascular system, and others. Pain can cause harmful chemical changes, stroke, heart attack, shock, broken bones and death.
As suggested by MIREGMGR, it would probably be prudent to go to the literature here. ...my feeling however is that, barring contraindications, temporary pain leading to the above conditions is highly improbable.

Or be considered harm:
(Statistical Steven) If it is temporary pain with no medical intervention (no aspirin) then might be minor.
(Pads38)I would suggest that pain causes "...damage to the health of people..."
I suppose the terms of "temporary" and "injury"/"damage to the health" are open to some interpretation here.

As an example, think of things like a muscle-spasm or a cold-headache. ...these are things that are intensely painful, but temporary. I wouldn't say these can be categorized as "injury" or "damage to the health", and hence not harm.

---

Loving the discussion everyone, thanks for all your inputs! :agree1:
 
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