IEC 62366 - Summative Evaluation

DanMann · Oct 19, 2023

Vicky Santos said:
This is an old thread, but I think my question is quite close to the topic.
I would like to get some idea or advise on Usability Engineering evaluation per EN 62366-1:2015 . Our medical device under evaluation is a Single Use Injector System, intended for use in the insertion of intraocular lens into the eye during cataract surgery. It is a class IIa device, with contact duration =less than 24 hrs. It is also a WET-established device. For the Usability Engineering verification we performed, a summative test, participants are our technical staff and not the intended user (Surgeon). Our NB questioned us and requested us to justify this.
Can someone help me to provide reference guidelines for justification? Appreciate so much your advise. Thanks!

I'd recommend looking at 62366-2, in particular the sections in User Groups and User Profiles. However, I think you'll struggle to justify having used your own staff to perform a Design Validation activity (i.e. Summative Evaluation). Are your technical staff trained as surgeons?

Vicky Santos · Oct 19, 2023

DanMann said:
I'd recommend looking at 62366-2, in particular the sections in User Groups and User Profiles. However, I think you'll struggle to justify having used your own staff to perform a Design Validation activity (i.e. Summative Evaluation). Are your technical staff trained as surgeons?

Thanks for the advise. Our technical staff evaluated and validated the operating techniques of manual loading of the lens into the injector, and the pushing method of the lens until it moves forward and comes out of the injector tip without lens damage, during the design stage. This technique was disclosed in the IFU of the device, with a safety warning that the surgeon to follow the procedure correctly.. We think that this use-related safety and effectiveness validation can be done by our technical staff, in our usability engineering report.
I will be checking 62366-2.

yodon · Oct 19, 2023

I agree with @DanMann - your approach will unlikely be acceptable.

Vicky Santos said:
a safety warning that the surgeon to follow the procedure correctly

This may be the deathblow to your argument! How will you know if surgeons can and will follow those procedures without seeing it done by them?

Vicky Santos · Oct 19, 2023

yodon said:
I agree with @DanMann - your approach will unlikely be acceptable.

This may be the deathblow to your argument! How will you know if surgeons can and will follow those procedures without seeing it done by them?

clearly understand.. thank you.

Al_Z1 · Oct 23, 2023

Totally agree with @yodon. We somehow justified this approach partly, cause we had specialist with relevant clinical experience in our team. But NB reviewer said, that it is not enough, so we made full validation with about 15 medical specialists and 30 tests for device use scenarios.

Vicky Santos · Oct 23, 2023

Al_Z1 said:
Totally agree with @yodon. We somehow justified this approach partly, cause we had specialist with relevant clinical experience in our team. But NB reviewer said, that it is not enough, so we made full validation with about 15 medical specialists and 30 tests for device use scenarios.

Thanks for the information, as expected, our NB reminded us of the same. Summation re-evaluation is under preparation..

IEC 62366 - Summative Evaluation

DanMann

Quite Involved in Discussions

Vicky Santos

Starting to get Involved

yodon

Vicky Santos

Starting to get Involved

Al_Z1

Involved In Discussions

Vicky Santos

Starting to get Involved

Similar threads