Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are a little late on the bandwagon here, but while we make our transition to IEC 62366-1:2015, I've started having trouble with some of the requirements of IEC 62366-1.

We cleared our product in the US and Europe with IEC 62366:2007 in 2014.

IEC 62366-1:2015 now requires 'formative' and 'summative' evaluations, with requirements and criteria that we did not do back when we were performing these usability studies. For example, "Documenting the criteria for determining whether the USER has successfully completed the TASKS associated with the HAZARD-RELATED USE SCENARIOS is required." We did not specifically note down 'hazard-related use scenarios' in the usability study, nor whether the user 'successfully completed the task.' Instead we surveyed them afterwards about any difficulty the had performing the task, with notes in the comments fields of the test cases for any failures.

Do I now need to go back and edit my old usability studies to use the 'correct' terminology, even though these studies were sufficient previously and the device has been in use for years now with an extremely small amount of complaints relative to our sales numbers? Do I need to perform a brand new usability study?

Thank you!

Hello Anon,

I experienced the same thing a couple times in 2016, 2018 where we were in the middle or just completed a study which was performed.  Luckily, the later study was already started after the FDA's guidance was published so we did not have that much variation to the IEC 62366 standard.  With any update to a standard, the recommended practice is complete an assessment or gap analysis against current processes and those "new" requirements under the revised standard.  This gap analysis can then be used to determine what changes, impacts, or even having to complete new testing.  In the case when we already had an on-going study, we did the assessment, determined the impacts, and created a supplement to our existing work.  We finished out the usability study as is, so in your case it is already done.  We then had this gap analysis, impact assessment, and supplement report which addressed other aspects which were not already completed; like the same updating our risk management file to clearly define user-related hazards.  This supplement not only was an addendum to our usability study, but we had to update our risk management, and also make updates to our instructions for use.  All of this was captured in this supplement/addendum.  There are other ways this could be done, this is just an example.  The point is you do not necessarily need to go back doing a completely new usability study, first is determining the gaps, deviations, and impacts which need to be closed to ensure full compliance with a claimed standard.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Jan-2022 17:02
From: Anonymous Member
Subject: How to manage transition from IEC 62366:2007 to IEC 62366-1:2015?

This message was posted by a user wishing to remain anonymous

We are a little late on the bandwagon here, but while we make our transition to IEC 62366-1:2015, I've started having trouble with some of the requirements of IEC 62366-1.

We cleared our product in the US and Europe with IEC 62366:2007 in 2014.

IEC 62366-1:2015 now requires 'formative' and 'summative' evaluations, with requirements and criteria that we did not do back when we were performing these usability studies. For example, "Documenting the criteria for determining whether the USER has successfully completed the TASKS associated with the HAZARD-RELATED USE SCENARIOS is required." We did not specifically note down 'hazard-related use scenarios' in the usability study, nor whether the user 'successfully completed the task.' Instead we surveyed them afterwards about any difficulty the had performing the task, with notes in the comments fields of the test cases for any failures.

Do I now need to go back and edit my old usability studies to use the 'correct' terminology, even though these studies were sufficient previously and the device has been in use for years now with an extremely small amount of complaints relative to our sales numbers? Do I need to perform a brand new usability study?

Thank you!

Hi,

My advice would be the you conduct and document a gap analysis between the two standards. This should identify any actions /remediation that needs to be taken. Where the standards differ and it is believed no action is required, a strong justification should be noted. If the outcome of this exercise is that you truly do not need a new usability study, then this will allow you to confidently defend this in an audit situation.

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Folasade Sobande
Woking
United Kingdom
------------------------------

Original Message:
Sent: 11-Jan-2022 17:02
From: Anonymous Member
Subject: How to manage transition from IEC 62366:2007 to IEC 62366-1:2015?

This message was posted by a user wishing to remain anonymous

We are a little late on the bandwagon here, but while we make our transition to IEC 62366-1:2015, I've started having trouble with some of the requirements of IEC 62366-1.

We cleared our product in the US and Europe with IEC 62366:2007 in 2014.

IEC 62366-1:2015 now requires 'formative' and 'summative' evaluations, with requirements and criteria that we did not do back when we were performing these usability studies. For example, "Documenting the criteria for determining whether the USER has successfully completed the TASKS associated with the HAZARD-RELATED USE SCENARIOS is required." We did not specifically note down 'hazard-related use scenarios' in the usability study, nor whether the user 'successfully completed the task.' Instead we surveyed them afterwards about any difficulty the had performing the task, with notes in the comments fields of the test cases for any failures.

Do I now need to go back and edit my old usability studies to use the 'correct' terminology, even though these studies were sufficient previously and the device has been in use for years now with an extremely small amount of complaints relative to our sales numbers? Do I need to perform a brand new usability study?

Thank you!

Have you looked into the 2020 amendment for 62366-1?
It includes changes to summative evaluation, here's a summary from UL:
https://www.emergobyul.com/blog/2020/09/2020-amendments-iec-62366-implications-medical-device-usability-engineering

If you do go back and update things - A hazard related use scenario can often be linked to a potential 'use error'. Have you been through your risk management file, some of the risks identified could be traced back to the above (reverse engineered). If your risk matrix is very detailed and descriptive, could you justify that ['hazardous situations' relating to 'use error'] cover most of your 'hazard-related use scenarios'.

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Chris Barkway
Petersfield
United Kingdom
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Original Message:
Sent: 11-Jan-2022 17:02
From: Anonymous Member
Subject: How to manage transition from IEC 62366:2007 to IEC 62366-1:2015?

This message was posted by a user wishing to remain anonymous

We are a little late on the bandwagon here, but while we make our transition to IEC 62366-1:2015, I've started having trouble with some of the requirements of IEC 62366-1.

We cleared our product in the US and Europe with IEC 62366:2007 in 2014.

IEC 62366-1:2015 now requires 'formative' and 'summative' evaluations, with requirements and criteria that we did not do back when we were performing these usability studies. For example, "Documenting the criteria for determining whether the USER has successfully completed the TASKS associated with the HAZARD-RELATED USE SCENARIOS is required." We did not specifically note down 'hazard-related use scenarios' in the usability study, nor whether the user 'successfully completed the task.' Instead we surveyed them afterwards about any difficulty the had performing the task, with notes in the comments fields of the test cases for any failures.

Do I now need to go back and edit my old usability studies to use the 'correct' terminology, even though these studies were sufficient previously and the device has been in use for years now with an extremely small amount of complaints relative to our sales numbers? Do I need to perform a brand new usability study?

Thank you!

This message was posted by a user wishing to remain anonymous

Thanks everyone for your responses! I will look into the 2020 amendment and create a gap analysis document with any supplemental reports necessary. 

Grateful to be a part of this community!
Original Message:
Sent: 11-Jan-2022 17:02
From: Anonymous Member
Subject: How to manage transition from IEC 62366:2007 to IEC 62366-1:2015?

This message was posted by a user wishing to remain anonymous

We are a little late on the bandwagon here, but while we make our transition to IEC 62366-1:2015, I've started having trouble with some of the requirements of IEC 62366-1.

We cleared our product in the US and Europe with IEC 62366:2007 in 2014.

IEC 62366-1:2015 now requires 'formative' and 'summative' evaluations, with requirements and criteria that we did not do back when we were performing these usability studies. For example, "Documenting the criteria for determining whether the USER has successfully completed the TASKS associated with the HAZARD-RELATED USE SCENARIOS is required." We did not specifically note down 'hazard-related use scenarios' in the usability study, nor whether the user 'successfully completed the task.' Instead we surveyed them afterwards about any difficulty the had performing the task, with notes in the comments fields of the test cases for any failures.

Do I now need to go back and edit my old usability studies to use the 'correct' terminology, even though these studies were sufficient previously and the device has been in use for years now with an extremely small amount of complaints relative to our sales numbers? Do I need to perform a brand new usability study?

Thank you!