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picBy Marc Egeth

The FDA asks “consumers” to report “unexpected side effects after using a medical product, or experiencing other problems with any products that the agency regulates.” This includes “product quality problems and product use errors involving human health care products.” FDA directs “consumers” to MedWatch, which provides on a webform the option to indicate, “Used a product incorrectly which could have or led to a problem.”

A few minutes ago – after writing the previous paragraph, but before writing this paragraph – I went to get some lunch. On the way, I saw a man in an electric wheelchair stopped in the middle of a parking lot. I asked if he needed help, he said he did, and I pushed him to an electric outlet nearby. He said he thought he had charged it recently. I thought about asking him about whether he would be reporting his problem to MedWatch, but I figured the odds were basically 0% that is what he would be doing next, and furthermore I did not want to belabor the interaction. Your guess is as good as mine about additional circumstances leading up to and following the incident. I did not want to burden him with having to talk to me about the arcana of medical device use error reporting – if I asked him questions about following up about reporting device problems, I’d need to explain why I was asking, and it all felt like more conversation than I estimated either of us wanted to get into.

Did Reynold – let’s call him Reynold – know what a “product use error” is?  Does anyone? Did I know how to steer the wheelchair? – did I use the product incorrectly?  Should I have been pushing while the wheelchair was in whatever drive mode it was in, or might there have been a “manual” mode that I should have engaged first? How do people know that they should report to the FDA when they “use a product incorrectly” – that they are not to blame; that they should not and will not get in trouble – that the product design is the first candidate to blame for use problems? In our labs, we observe many study participants we interview making use errors in simulated use studies, blaming themselves, and/or trying to move on as if nothing happened. It is an axiom of the field of Human Factors that “the user is not to blame,” precisely because the product is not an intuitive concept, and because it needs to be said, and explained, continually to everyone who approaches the field.

We have “if you see something, say something,” and “How am I driving? Call 1-800-” all over the place. Like these, medical device use error reporting is an area where there is an opportunity to improve safety by crowdsourcing the reporting process. These other reporting mechanisms might be successful because they have people blaming other people – someone else’s driving; someone else’s suspicious activity. A new use error reporting meme should be specifically designed to overcome people’s reluctance to come anywhere near casting blame on themselves. What does this mean? Anonymous reporting, maybe; repeated messaging about “the user is not to blame.” Any other ideas here?

I suspect that currently, “I messed up using my X device” is not something anyone expects to be reporting to a government website, for various reasons. But how many lives would be saved, or just improved, if everyone reported use errors – which in the long run would cause people in the future to not mess up” using their X device, as the devices could be redesigned so that the “error” is no longer committable. Maybe electric wheelchairs unexpectedly running low on stored battery power is a widespread pattern that could be solved with a better low-battery indicator.

Achieving wider scale effective reporting of “use errors” will require confronting and accounting for the following:

  1. How people reason about blame and about causality
  2. How people become aware of their own patterns of behavior
  3. How people understand technology
  4. How people see themselves as active partners in development of future technology
  5. How people can be helped to respect themselves as blameless with respect to medical device use errors and deserving of having access to easy to use, safe, and effective medical devices

Instead of requesting reporting of “serious” “product use errors” where a “consumer” “used a product incorrectly,” here is some possible prose a device error reporting website might consider to work in the direction of inviting users of medical devices into the process of iterative human factors design:

The FDA is interested in helping to make medical devices easier to use, safer, and better. Devices includes everything from your contact lenses to your blood glucose meter to your grandfather’s motorized wheelchair. Any time you have any sort of problem with a device, we think it is not your fault – and we want to know about it. Maybe you think you foolishly pushed the wrong button, or forgot to change the battery. No – we think the button maybe should have been placed differently, and the thing should have warned you better that the battery was running low. We care about problems of any sort – a minor inconvenience for you might be a major roadblock for someone else. Medical devices should work for you.

Please let us know any time you have any sort of issue operating any sort of medical device. This includes any sort of mistake you think you have made, or any time a device has let you down or not done exactly what you expect it to do. This even includes any time the instructions have been confusing, or any time you were worried you had done the wrong thing or the device had done the wrong thing.

 Let us know so we can all work on making better devices for the future, so our children have the technology they deserve to keep them safe, happy, and healthy.

[fields here to collect details of issues encountered]

But, how does a person even know that a government agency is “on the case,” working to help lead industry towards safe and effective medical devices? Why would people seek out such a reporting website – do people realize contact lenses are “medical devices?” If this is an issue, then perhaps let a phone number and weblink indicating the above sort of respectful solicitation of use errors sit on product packaging and instructions.

Going further, why not gamify and crowdsource use-error reporting. Let “consumers” – people, – in other words [1] – submit descriptions of use errors, as defined in non-technical language. Then make viewable to people the set of reported issues, and let other people submit potential fixes. Reward submissions that point to real issues and fixes that are recognized as potentially helpful and practical improvements. Challenge.gov currently posts technical issues of interest that everyone starting from grade school might solve. It’s just software and words – an update to an existing portal, adding some features already present on crowdsourcing initiatives like challenge.gov. A human-factors approach to the process of medical device use error reporting that centers on blamelessness on the part of the user and iterations of creative development might get people reporting – and thinking about – real issues and real solutions.

How can we find societal space for encouragement and a phone number and link to report a difficulty with a medical device?

[1] Why not the language of “consumer?” I was not a “consumer” of the wheelchair in the parking lot. As far as Reynold, he may not have chosen to buy it, and may not have bought it at all, depending on how his insurance worked. It is only by a stretched or unusual use of the word “consumer” that the word “consumer” would apply to me as the person who might report a use error about this difficult wheelchair. But, “people” applies very easily to describe the subset of people who could be involved.