One of the fundamental principles of human factors and product development is to ensure that the medical device is designed in a manner in which the user can effectively use the product. It should not be the other way around; users should not be required to adapt to the device. Unfortunately, designers do not always adhere to this philosophy. And when a use error occurs, some are quick to blame the user during the path of uncovering the root cause.
“There’s a gut instinct to think that it was the user’s fault—the user was forgetful, was careless, [and] was not paying attention… because indeed it takes a human being to make a mistake,” said Michael Wiklund, general manager of human factors engineering at Wiklund R&D, during a recent webinar, “Analyzing the Root Causes of Medical Device Use Errors”. Wiklund estimates that when use errors occur, the user is solely responsible in just one out of 100 instances. As such, he encourages the examination of the user interface itself and discourages folks from taking the easy path of blaming users for errors. “Our job as human factors specialists is to consider the possibilities of what happened.”
According to Andrea Dwyer, managing human factors specialist at Wiklund R&D, the root cause analysis process is a form of sleuthing. “It’s both a systematic, technical approach, but it requires some creativity to get to get to the true insights,” she said. It’s critical to take a structured approach to root cause analysis. Dwyer advises following seven steps during the process:
- Define and document the use error
- Identify provisional root causes
- Analyze anecdotal evidence. Talk to the person who might have committed the error to get a sense for why he or she thinks it occurred.
- Inspect the device for user interface design flaws (i.e., flaws related to hardware, software, or instructional materials associated with the device)
- Consider other contributing factors beyond the design-specific root cause that might have been considered in Step 4
- Develop a final hypothesis
- Report the results
For more details about these steps for success in getting to the root cause of use error, view the archived webinar.
Related Articles
-
The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement…
-
On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
-
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
-
Registration is now open for the MedTech Regulatory Intelligence Summit in Washington, DC, May 16-17. Join us as we take a closer look at strategies and best practices in developing an effective and sustainable regulatory strategy for today’s global market.
