An example of risk analysis of class I MD

[Tidge]

Just a point of clarification, for future reference:

... I was referring to making a determination as what types of injury require professional medical intervention...

The linked example specifically ranked severity classifications using the terminology "injury requires professional medical attention" with no particular identification of any harms. I feel that this was a very poor choice for this specific example, given that the harms were not identified and the identified person responsible (in the linked example) for making the assessment was a design engineer. Each of us may personally know individuals who fall along different points of the spectrum between hypochondria and a stubborn refusal to seek medical treatment!

In my general experience, 5-point scales for severity rankings are often commensurate with a general concept of "how much medical attention", but that specific terminology can be problematic. I am much more comfortable with having a general list of specific harms, each with an identified Severity rating. If possible, such a "master harms list" ought to be vetted by an accredited medical professional familiar with the identified harms; if such a professional isn't familiar with the application of 14971, they may need to be informed about the theory of separation of S from P1 and P2. Strictly speaking 14971 doesn't require such a person, but it doesn't require that electrical engineers know how to use a digital multimeter either.

 

[Watchcat]

If you recall, I was referring to making a determination as what types of injury require professional medical intervention. Not the severity of the clinical harms in general.

Yes, I did note that when I asked for an example. However, you were responding to Tidge's comment, which was broader in scope:

I feel that there may be some ambiguity about who came up with the severity of harm ratings... my strict reading of the file implies that it was the Engineering R&D associate. Engineering associates are typically not qualified to make a determination as what types of injury require professional medical intervention.

Having not read the sample report, I nonetheless concluded that, as I believe Tidge clarified later, whether or not an injury requires professional medical intervention is one of the criteria used to rate severity. Beyond that, if someone without clinical training and experience can assess some risks and not others, this seems like a moot point, since that is not enough to do a full risk assessment, even if you think this criteria is an appropriate one to use. (It might be appropriate for doing a one-off assessment of a single reported incident, but so far this discussion has been from the perspective of a risk management report, which I understand to be comprehensive.)

Regardless, I asked the question anyway, because I am fine with either interpretation.

How would you assess the severity of the clinical harms that are potentially associated with the equivalent of a paper cut, using only the criteria of whether or not they would require professional medical attention?

PS I also noted that you did not specifically say you were comfortable doing this type of assessment yourself, only that you did not think an MD or RN was necessarily required.

 

[Ronen E]

The linked example specifically ranked severity classifications using the terminology "injury requires professional medical attention" with no particular identification of any harms. I feel that this was a very poor choice for this specific example, given that the harms were not identified and the identified person responsible (in the linked example) for making the assessment was a design engineer.

I don't understand how this is related to the my response quoted above this text. That response of mine was not in argument for "the linked example" (I also never argued anywhere that it's perfect). It was merely in response to @Watchcat's question, and I gave it in the general context of medical devices risk management, not specifically in "the linked example"'s.

In my general experience, 5-point scales for severity rankings are often commensurate with a general concept of "how much medical attention", but that specific terminology can be problematic.

That terminology (along "professional medical intervention is/isn't required for preventing irreversible damage to health") is common because it originates - if my memory doesn't betray me - from older regulations and official / semi-official guidance documents. I think it's not something invented by industry alone.
General scales (be they 3, 5 or more points) are, IMO, too subjective if not accompanied by fairly clear verbiage to denote the meaning of each level.

 

[Ronen E]

Yes, I did note that when I asked for an example. However, you were responding to Tidge's comment, which was broader in scope

That's factually incorrect. I was responding to a very specific sentence from @Tidge's, which I quoted in that response.

Beyond that, if someone without clinical training and experience can assess some risks and not others, this seems like a moot point, since that is not enough to do a full risk assessment, even if you think this criteria is an appropriate one to use.

I never argued that clinicians are never necessary in a risk management process or that engineers can always determine the severity of patient/user harms. I was making a very explicit argument that in some cases engineers can quite accurately determine whether professional medical intervention would be required. Of course I agree that in many (most?) cases the participation of appropriate clinicians is necessary for a comprehensive and complete risk management process.
Nevertheless, there are cases (simple, low risk devices) where the whole exercise can be effectively completed without getting a clinician involved and the risk management would still be sound. In such cases it would usually be a waste of time and money to force such participation. I was mostly objecting the generalisation implied from @Tidge's post.

How would you assess the severity of the clinical harms that are potentially associated with the equivalent of a paper cut, using only the criteria of whether or not they would require professional medical attention?

Why would I use that criterion only? Did I state anywhere that I think that this is the only relevant criterion? If it was, there would be only two levels of severity in that ranking system.

PS I also noted that you did not specifically say you were comfortable doing this type of assessment yourself, only that you did not think an MD or RN was necessarily required.

(emphasis added)
...for determining the need for professional medical intervention, in some cases (such as the example I gave), not for the whole risk management process, in all cases!...
And, sometimes I would be comfortable doing this type of assessment myself* (even the whole assessment) - it depends on the device.
(* By "myself" I don't mean me as a single person - which is always a bad idea for risk management and also against 14971 - but me as a member of a very small team [say, 3 members] that may well exclude a clinician).

 

[Watchcat]

Ok, so clearly you are not going to let me make an example of you , so I will let this one go. Maybe another day...

 

[big boss]

could i have the example pls

 

[Ronen E]

could i have the example pls

What examples?
Which post were you responding to?