BSI White Paper on Human Factors/Usability Engineering

[Lerotronic]

Beginning this year BSI had issued a white paper titled "The growing role of human factors and usability engineering for medical devices".
It provides a small overview of HF/UE for the medical devices industry, current regulatory standpoint regarding this topic and concerns the industry has with it.
The piece could be found by googling the title (I am unable to post the link ).

What are your thoughts on this document and what implications do you think it will have?

Cheers!
Milo?

 

[yodon]

Milos, thanks for the tip.

Here's the link: http://www.bsigroup.com/LocalFiles/...usability engineering for medical devices.pdf

(It DOES require registration to get access.)

I think the title is pretty accurate, the *growing* role of HF and usability engineering. I attended a RAPS-sponsored seminar from UL a few weeks ago on the same topic. There is an evaluation of a system's usability as part of 60601 (-1-6) so I think this will be an area more closely scrutinized as we move forward.

I think there are at least 2 factors driving this. First is the sheer amount of devices being deployed. I saw a picture of an OR where there must have been 50 devices dedicated to a patient. Imagine the confusion if several alarms go off at once or if similar devices use slightly different conventions.

The other is the trend towards home health care. Many devices are now going home with patients. Even implantables are having more and more use interface in the home. This moves usability out of the clinicians hands and into a vastly diverse population.

My takeaway from the UL presentation I attended was that 62366:2015 is a step in the right direction. There's a re-focus on safety over (strictly) usability. I think device manufacturers will, if they haven't already, need to implement a Human Factors Engineering program and start making HF a standard part of their development operations.

It's an interesting topic and, again, thanks for raising it. It will, indeed, be interesting to see how it plays out.

 

[Pads38]

Hi Milos,

To simplify things here is the link:

http://www.bsigroup.com/en-GB/our-services/medical-device-services/BSI-Medical-Devices-Whitepapers/

(Registration required - free)

As for the article - it is a reasonable summary of the usability process, and tries to cover both the IEC/European approach and the FDA/US approach.

But I don't think it provides anything new. It all makes perfect sense for devices where the 'User Interface' is a critical element of the design (ITU monitors, home use devices, drug pumps etc) but does not really help when the UI is of no real consequence to the risks of the device. This may because the UI is very simple or it could be because any UI induced errors would be very limited due to the purpose of the device.

Edit:
Too slow!

 

[yodon]

I guess a good question is whether anyone has had any experience with test labs or other parties (FDA inspectors, ISO registrars) asking for evidence of usability engineering / usability studies?

 

[c.mitch]

Yes Yodon, in Europe, my customers already had CE mark audits with non-conformities on usability essential requirement. The NB auditor was expecting a usability study file compliant to IEC 62366.

 

[Pads38]

The organisation that sets the standards for Certified Bodies (the 'officially' recognised test houses) is the IECEE. They have published a guidance document on the use of standards, of the 60601 series, to get a CB Certificate.

(Link: http://www.iecee.org/Operational_documents/od-cb_index.html
look for OD-2055
Also get the 'Definitions and Acronyms' document - you will need it!)

In the annexes to OD-2055 there is indication that an Edition 3.0 60601 certificate need not include 60601-1-6. The 'Notes' suggest that this is only required when 60601-1-8 (Alarms/Bells/Whistles) and/or 60601-1-11 (Home environment) are included.

However, for a Edition 3.1 certificate, 60601-1-6 is required for all devices.

 

[Marcelo]

The organisation that sets the standards for Certified Bodies (the 'officially' recognised test houses) is the IECEE

Just take some care here. IECEE is one "scheme" for accreditation. IN fact, for labs, the scheme most used worldwide is the ILAC one, and it does not have any document on IEC 60601, risk management, or anything related.

For example, we do not accepted IECEE testing and certification for medical devices in Brazil.

 

[Lerotronic]

Yes Yodon, in Europe, my customers already had CE mark audits with non-conformities on usability essential requirement. The NB auditor was expecting a usability study file compliant to IEC 62366.

Hi c.mitch! This is very interesting notion. Could you tell us something more about it?
Something I was lacking in the white paper above is actually some insight on how the Notified Bodies are enforcing compliance with the usability requirements, for CE marking.

 

[c.mitch]

Same old story.
Iec 62366 is an harmonized standard and gives presumption of conformity to essential requirements re. usability.
Thus they look for evidence of validation of usability. If you have no evidence and you don't claim the standard, you get an NC re. essential requirement. If you claim it, you get an NC on standard requirements.

 

[Mark Meer]

Thus they look for evidence of validation of usability.

Curious: is IEC 62366 becoming another "de-facto" standard (much like the 60601 series), whose path of least resistance would entail a report by some accredited 3rd party?

If so, I think this would be a negative thing for a lot of developers.

Having evidence of usability risk management and validation is one thing (and normally already part of design process)... but having strict compliance to IEC 62366 (especially if it involves 3rd-party assessment) is additionally burdensome IMHO...