Usability Plan for Existing Equipment

patmelad

Starting to get Involved
#1
I have come upon the task of getting a 60601 3rd edition test done on a product that has been used in the field for already 20 years. We acquired the company 10 years ago with the existing product, and do not have access to any of the original design or usabilty studies that were done when the project was started.
We are currently ISO 13485 and ISO 9001 certified and have a CE Mark for the product.
How can I successfully address the usability issue that now comes up with the 3rd edition?

Any suggestions would be appreciated.
Also I might mention that there have been No incidents ever reported with this equipment and it has been used by patients all over the world
 
Elsmar Forum Sponsor
#2
I am in a similar position. My intention is to state that no amount of Usability testing can be a better test than the (20) years of documented use by many users that have already taken place.

Back that up with evidence from your post marketing surveillance etc. I would suggest that documented positive feedback is more powerful than a lack of negative feedback.

Of course, at this stage, I don't know if this will be seen as adequate by our auditor.
 
Last edited:
#4
Do you have any examples of Usability process file or usability validation plan?
Yes - but they are very specific to our equipment, as I suspect yours will have to be for your devices.

The best guidance I have found, alongside the standard itself, is the book "Handbook of Usability Testing" by Jeffrey Rubin and Dana Chisnell. It is quite readable.
 

Peter Selvey

Staff member
Super Moderator
#6
You are probably better off creating a report which covers the content of the standard (e.g. specification, plan, validation, etc), and then applying flexibility in the core part which is the testing. For example, you might say the specification is met based on inspection and market experience, rather than actual tests on people. That should be OK as long as it is plausible.

For low risk devices, the focus can be very limited. For example, if it is a measurement device, just things that could lead to a inaccurate measurement (from the user's perspective). The ability to turn the thing on, change the batteries etc don't need to be analyzed unless there is some significant potential for harm.

Keep in mind that 20 years market experience does not mean the device has no usability issues. I've done a bit of research into prediction type electronic thermometers. These devices take up to 10 minutes to get a real reading, so they use a prediction function to get a faster result. They are great under bench tests, and pretty good in controlled clinical tests. But you need to carefully follow the procedures to get a good result.

I wince every time I see my wife using one on the kids, and the results are all over the place, sometimes errors more than 1degC. That kind of stuff doesn't get reported. It's not like most people have a handy reference meter there to tell people they got a wrong temperature result. A lot of problems in medical devices are like this, real problems but not easily detected in the market. So the absence of market reports itself is not always good evidence.
 
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