New EU Medical Device Regulations - Q1/2 2017 and Human Factors

Hello,
I assume that most people know about the new EU Medical Device Regulation which will entry into force probably Q1/2-ish 2017...

What are your thoughts about this regarding Human Factors / Usability?
It is mentioned a few times, which I really like, but I somehow miss the alignment with 62366.
Any thoughts?
Cheers
Tobias

The new requirements are not that much different from the ones on the 2007 MDD revision, meaning, they are generic requirements related to human factors/usability. On the other hand, the new regulation has a strengthened focus on risk management, as as human factors/usability is part/uses/have a strong relationship with the risk management process, it will also benefit.

Also note that the current MEDDEV on clinical evaluation does have expectations regarding usability (which I do not agree because I think it mixes things with different objectives), so when the new regulations published and the MEDDEVs revised, they will probably maintain this aspect.

Hi Marcelo,

I am not sure, if I understand you correctly. The current MEDDEV on clinical evaluation 2.7/1 rev. 4 expects, for example, the manufacturer to include "confirmation of usability, that the design adequately reduces the risk of use error as far as possible, and that the design is adequate for the intended users". It also mentions the EN 62366 as a harmonised standard which is "expected to be applied".

I am sorry, if I missunderstood you.

L_O_B said:

Hi Marcelo,

I am not sure, if I understand you correctly. The current MEDDEV on clinical evaluation 2.7/1 rev. 4 expects, for example, the manufacturer to include "confirmation of usability, that the design adequately reduces the risk of use error as far as possible, and that the design is adequate for the intended users". It also mentions the EN 62366 as a harmonised standard which is "expected to be applied".

I am sorry, if I missunderstood you.

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The focus of clinical evaluation is to obtain clinical data (patient data) to show conformity with specific essential requirements (ER 1, 3 and 6, and any claim).

Usability is related to the user interface, how the user interacts with the device. It has nothing to do with clinical data.

The focus is on clinical data. But clinical data is defined as "safety and/or performance information that is generated from the clinical use of a device". I do not see a limitation on patient data only.
And what better data could be there to assess usability, than reports of the actual user out of the actual user environment?
Also you mention the essential requirement 1 which includes minimizing the risk of use errors and thus makes up the basis for usability requirements doesn't it?

To answer the topic: There are several points in the general safety and performance requirements requiring usability management. What kind of alignment did you expect/hope for?

Hi,
well I was kind of hoping for more direct links to 62366. But you are right, the focus on risk management / reduction is for sure a good argument for HF.

What I also liked is in the Annex 1, 2b
2b. In eliminating or reducing risks related to use error the manufacturer shall apply the following principles:[..]
consideration of the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
--> we often forget that also health care professionals can have impairments (due to age, etc.). And what can be annoying with normal products, if you can`t read the small print or have problems to click the small button, can have severe consequences with a medical device. Especially with an ever older getting workforce!

The focus is on clinical data. But clinical data is defined as "safety and/or performance information that is generated from the clinical use of a device". I do not see a limitation on patient data only.

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Yes, I agree that the current definitions do not preclude usability requirements being analyzed too, what I mentioned is that I do not agree with the concept.

And what better data could be there to assess usability, than reports of the actual user out of the actual user environment?

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A usability evaluation forces use errors. You have to design your usability testing so that error that should appear, will. That's one of the reasons you do not perform usability testing with actual device use, otherwise you could "kill"the user or patient. So no, data from actual use is not the best data (although data from actual use can be used as confirmatory data after usability evaluations have been performed, however, as I mentioned, they do not necessarily show errors - and lack of use error in use does not directly equates to good usability).

Also you mention the essential requirement 1 which includes minimizing the risk of use errors and thus makes up the basis for usability requirements doesn't it?

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Due to the way the 2007 revision included the two paragraphs on use errors, yes, but again, I do not think that they should be there.

That's why it was moved to 2.a in the proposal for the new regulation.

Please accept my apologies in advance, but I`ll have to disagree just a bit. And this may get a bit off-topic as well....
In usability testing (at least summative testing) we do not design the study to force use errors - we focus on the risk based tasks. Those with the highest severity, followed by those with severity and probability.
And yes, we can use real data from real users in usability assessments (lets not call this testing..), especially for Post-Market surveillance.
Which, to my recall, is a nice point in the MDR, but I can`t remember if its that prominent in 62366 (on topic again, yay!)
Cheers
T.

I agree.
I did not want to use the clinical evaluation as a usability test. But you have to check post-market data in the clinical evaluation to assess if your device is safe and performs as intended. I do not see a reason to exclude usability data.
If you see something that did not work well on your device, you can use it as input for usability management.
If you see something that did not work well on an equivalent device of a different manufacturer that you already addressed in your usability management, you have a good point to support your clinical evaluation.

Tobias_HF said:

In usability testing (at least summative testing) we do not design the study to force use errors - we focus on the risk based tasks.

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Yes, I agree that in summative testing you do not "force"use error, but you may be missing my point -you are still looking for them. Only if your HFE/usability process was done correctly, you won't find them. It is still the same problem as I mentioned, before the summative testing, you do not have a "guarantee" that your device is (mostly) error-free.

An analogy that I use might help. If you are not sure of error and put people in a plane to travel, the outputs might be: the plane crases and everyone dies, then you can confirm that the errors exist, or the plane might land safely, then you can confirm that it could have taken off.

Not a great way to confirm something. It's more or less the same thing as using a clinical evaluation to confirm usability (as I mentioned, it obviously can be used, as well as post-market data fro real use, as a way to confirm).

I do not see a reason to exclude usability data.

Click to expand...

I did not say that you should not use usability data either from the clinical evaluation or any other source. My problem is to link this directly as being part of the clinical evaluation. It would be better. in my point of view, to require that this data is fed back into the usability engineering process. The way the MEDDEV says it, it seems that the usability engineering process is part of the clinical evaluation. Worse, the MEDDEV clearly says that the clinical evaluation includes "confirmation of usability, that the design adequately reduces the risk of use error as far as possible, and that the design is adequate for the intended users". That's what I do not agree with, that the clinical evaluation confirma usability. This makes no sense.