New version BS EN ISO 14971:2012 released - July 2012

[jradford]

So what are people using for their risk chart? Just replace ALARP with ALAP or AFAP? Or is the risk back to low, medium, high? I have been looking for examples and not seeing any around. All the ones I see on the www still show ALARP.

Thanks for any input.

 

[wrodnigg]

My point is to get rid of ALARP and others:

Either a risk is acceptable, or not. In some cases a non-acceptable risk may be justified as tolerable considering the medical benefit.

And I refer on the MDD (and not on the standrad):

The devices must be designed and manufactured in such a way that,
when used under the conditions and for the purposes intended, they
will not compromise the clinical condition or the safety of patients, or
the safety and health of users or, where applicable, other persons,
provided that any risks which may be associated with their intended
use constitute acceptable risks when weighed against the benefits to the
patient and are compatible with a high level of protection of health and
safety.

The goal is patient and user safety, not "riskless" devices.

There is no requirement to reduce risks as long as there is some money left to spend...

And to my (expert) opinion a risk process according ISO 31000 is much better than the tinkered ISO 14971 approach and fulfills all of the 14971 requirements (if implemented properly).

 

[Ronen E]

My point is to get rid of ALARP and others:

Either a risk is acceptable, or not. In some cases a non-acceptable risk may be justified as tolerable considering the medical benefit.

And I refer on the MDD (and not on the standrad):



The goal is patient and user safety, not "riskless" devices.

There is no requirement to reduce risks as long as there is some money left to spend...

And to my (expert) opinion a risk process according ISO 31000 is much better than the tinkered ISO 14971 approach and fulfills all of the 14971 requirements (if implemented properly).

Hi,

This is great and I tend to agree, however, the $1M question is how you determine objectively that a risk is acceptable. The answer is that you can't, because "acceptable" is very subjective unless it is standardized (which relates to the path "compatible with a high level of protection of health and safety" = satisfies a published health / safety standard), or brought down to absolute zero (as in the ridiculous AFAP approach).

ISO 31000 might well be better, but IMO an ISO 14971 compliant process can still achieve the purpose of systematically weeding out unacceptable risks, if implemented properly. The problem is not the standard, but the inherent conflict of interest between safety and short/mid-term profitability.

Cheers,
Ronen.

 

[MIREGMGR]

The problem is not the standard, but the inherent conflict of interest between safety and short/mid-term profitability.

While I get the point and don't disagree with its importance, it's also important to note that even the most altruistic of firms will have a similar problem with the conflict between safety and benefits. Medical care has lots of risks. In many cases, the conceptually available paths to greater safety would decrease or eliminate product benefits, because the same parameter controls both safety and benefit.

 

[Ronen E]

While I get the point and don't disagree with its importance, it's also important to note that even the most altruistic of firms will have a similar problem with the conflict between safety and benefits. Medical care has lots of risks. In many cases, the conceptually available paths to greater safety would decrease or eliminate product benefits, because the same parameter controls both safety and benefit.

I usually take "benefit" in this context to mean "patient benefit, in the clinical sense", however that is just my habit and I haven't seen it scribed anywhere. Perhaps it's beneficial (pun intended) to specify what type of benefit one relates to in any given instance. Surely when weighing risk vs. benefit from a company (=commercial entity) perspective, it's highly important to distinguish between clinical outcome benefits and commercial outcome benefits. Sometimes they are the same, but in the short/mid-term/range they are more often conflicting.

I accept that there may be cases where a certain technological / design / use parameter increases safety and at the same time decreases patient clinical benefit. However, I tend to refuse the thought that there are more than very few cases where all conceivable ways to increase safety are such. If I'm right, then in the vast majority of cases it does come to the clinical benefit vs. cost conflict.

Cheers,
Ronen.

 

[MIREGMGR]

Yes, benefit needs better definition. I and others have discussed before how societal benefit (i.e. lower procedural cost, therefore societal affordability of provision of more clinical procedures within an available societal budgetary limit) may have little or no correlation to individual-patient benefit. In most countries, individual medical device makers and even medical device regulators are not in a position to make what usually are national-legislative decisions as to what societal benefit is desired or required.

 

[Ronen E]

Yes, benefit needs better definition. I and others have discussed before how societal benefit (i.e. lower procedural cost, therefore societal affordability of provision of more clinical procedures within an available societal budgetary limit) may have little or no correlation to individual-patient benefit. In most countries, individual medical device makers and even medical device regulators are not in a position to make what usually are national-legislative decisions as to what societal benefit is desired or required.

This might be true, however I believe that the original intention behind the "risk vs. benefit" language in medical devices standards and regulations is that direct patient clinical benefit is what's weighed against direct patient / user risk. General patient population affordability benefit is too indirect and too easily "recruitable", to justify direct significant risk for an individual patient on / by which a device is used.

Cheers,
Ronen.

 

[wrodnigg]

I recently had a discussion with a client, when I told them, that a unlikely risk which can lead to a dead patient, can not be judged as acceptable (they declared this area in their risk map as acceptable).
Now the come to an unacceptable but tolerable risk, since the patient would certainly die if he would not undergo the treatment.

The main question is a systematic one. Thats the reason, why i demand a justification for the risk scales and the acceptance criteria.

Risk is an essential part of our existance and non-acceptable but tolerable risks are part of the game. Yes, of course, a bureaucrat would never accept this viewpoint...
(but I am a practician)