Training as a risk control for ISO 14971

[yodon]

We have a healthy debate going on (14971:2012).

One side believes training can be used to reduce the likelihood.

The other side believes that training is still considered just information for safety and thus cannot be used to reduce the likelihood.

Has anyone bumped into this?

 

[Ronen E]

Hi,

I assume the debate stems from EN ISO 14971:2012 deviation #7:

7. Information of the users influencing the residual risk:

a) The residual risk is in 2.15 and in 6.4 of ISO 14971 defined as the risk remaining after application of the risk control measures. 6.2 of ISO 14971 regards "information for safety" to be a control option.

b) However, the last indent of Section 2 of Annex I to Directive 93/42/EEC says that users shall be informed about the residual risks. This indicates that, according to Annex I to Directive 93/42/EEC and contrary to the concept of the standard, the information given to the users does not reduce the (residual) risk any further.

c) Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users.

Item (b) tells me that the information to which “manufacturers shall not attribute any additional risk reduction” is information “about the residual risks”. If the training in question involves provision of other information, or skill-building or the likes, I think it can pretty safely be claimed to have a potential effect on the risk / likelihood, even in the face of deviation #7.

Cheers,
Ronen.

 

[mihzago]

I concur with Ronen.
People reading the deviation frequently confuse the information for safety with information about the residual risk. Two different things, and according to the deviation, only the information about residual risks cannot be used to control/reduce risks.

When you use training or information for safety, you should verify that such information is effective, e.g. through usability study.

 

[locutus]

+1 to what they said

 

[yodon]

People reading the deviation frequently confuse the information for safety with information about the residual risk. Two different things, and according to the deviation, only the information about residual risks cannot be used to control/reduce risks.

Agreed that we need to keep disclosure about residual risk separate and certainly that doesn't reduce the risk.

But if you look at the list of options to consider for risk controls (designing for inherent safety, protective measures, providing information for safety), provision of training is grouped under the "providing information" so based on the content of deviation #7 that Ronen points out, I don't see how this can be used to reduce the risk. This would have to assume then that every user to ever use the product will be trained and the training will be effective for the use life of the product. To me, this is hardly better than providing a user's manual (which, at least, can be referred to throughout the use life).

When you use training or information for safety, you should verify that such information is effective, e.g. through usability study.

I'll *certainly* agree to that!

 

[mihzago]

I think there is a general agreement that labelling is the least effective method of risk control and how much it reduces is debatable; but Content Deviation#7 does not prohibit you from using information from safety to reduce risk.

Why do you provide users with a user manual in the first place - isn't it to reduce the risk by ensuring proper use (among other things)?
Training may not necessarily be better, but it may be another option. Some people prefer watching/listening rather than reading, so training may be more effective in conveying the information for proper use than a manual.


here's an excerpt from the Team NB Position Paper regarding Content Deviation #7:

"ISO 14971 (Annex J) and ISO/TR 24971 describe ‘information for safety’ as instructions for use, warnings, required maintenance, etc.. ‘Information for safety’ comprises instructions of what actions the user can take or avoid in order to prevent a hazardous situation from occurring. On the other hand, ‘disclosure of residual risk’ has the objective to inform users of remaining risk inherent to the use of the medical device, and concerns the risks remaining after all risk control measures have been taken.

Recommendation:
Any information for safety comprising instructions of what actions the user can take or avoid in order to prevent a hazardous situation from occurring may be considered a risk control measure. As required by Essential Requirement 13.1 of Directive 93/42/EEC (respectively ER B.8 of 98/79/EC) it may be considered as a risk control measure. The information includes the instructions for use, labels, etc.. Since ‘safe use’ is related to risk control measures, the Medical Device Directives do not deviate in that regard from EN ISO 14971. Any effects on risk reduction are to be documented by the manufacturer in the risk management file.
‘Disclosure of residual risk’ should be conducted in compliance with EN ISO 14971 Clause 6.4, 6.5 and 7. The manufacturer shall not claim a reduction to the probability of harm when disclosing residual risk."

 

[Ronen E]

I don't see how this [provision of training] can be used to reduce the risk. This would have to assume then that every user to ever use the product will be trained and the training will be effective for the use life of the product.

I didn’t say that provision of training is guaranteed to reduce the risk. I just said that deviation #7 doesn’t block it from being considered as potentially doing so. The effectiveness of training in reducing risk (in fact, in achieving any defined goal) should be verified, and reduction of risk claimed only once some evidence-based rationale exists.

Another point to consider is that training can be much more than the “usual” frontal lecturing that clearly falls under “provision of information”. Training can be actual guidance in performing tasks or the likes. This can be quite different from just providing a manual. It may not be relevant for the case you are currently debating, but I thought it’s worth mentioning for a wider context.

Last, I don’t see the 3 options in the MDD as the only ways to reduce risks. The MDD doesn’t exclude other categories and it doesn’t say that all risk reduction means have to fall into these 3 categories. The way I see it, that clause is there just to force some order (priority) among those 3 categories, so that manufacturers won’t always go for the easiest (but less effective) options. If you ask me, training which is teaching of physical skills is more than “provision of information” and thus doesn’t fall into any of those 3 categories. So what? It doesn’t mean you’re not allowed to do it and it doesn’t say that it can’t be used to reduce risk (or at least try to).

 

[EthanLoh]

Training may not reduce the likelihood of the a risk. There are 3 methods of risk reduction based on EN ISO 14971:2012.
a) inherent safety by design;
b) protective measures in the medical device itself or in the manufacturing process;
c) information for safety.

 

[mihzago]

EthanLoh, please take a look at Appendix D, in particular section D.5.1 c).

"c) Providing information for safety by:
...
- providing training for the operators to improve their performance or their capability in detecting errors,"

 

[EthanLoh]

mihzago

Thank you for pointing out Annex D to me.

IMHO, I think there is a limit how much training can reduce a risk or contribute as a risk control method.

That may also link to effectiveness of the training.

Some people are just "un-trainable".