Is Pain considered Harm in ISO 14971?
- Thread starter Mark Meer
- Start date
Re: Pain considered harm?
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. Those who are experiencing pain may disagree though.
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. Those who are experiencing pain may disagree though.
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.
For all practical purposes, it should be. You definitely want to evaluate the risk associated with causing pain, and mitigate it as warranted.
Re: Is Pain considered Harm?
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...
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
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.
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.
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.
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Perhaps, due to damage, pain manifests. This pain may then cause some other damage... (Ex. Induce Fever)
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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.
So it seems to be different ways pain can be considered:
On the one hand not be considered harm:
Or it can present a hazardous situation that leads to harm:
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:
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.
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Loving the discussion everyone, thanks for all your inputs!
On the one hand not be considered harm:
Or it can present a hazardous situation that leads to harm:
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:
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.
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Loving the discussion everyone, thanks for all your inputs!
