Problems found in FDA medical device design guidance and human factors engineering validation criteria
According to a news release from Mauro Usability Science, there is indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations. This may lead medical devices that pass FDA HFE validation to still exhibit significant use errors when utilized by actual patients in the real world.
In addition, a report by the International Consortium of Investigative Journalists (ICIJ) indicated that 83,000 deaths and 1.7 million injuries were linked to medical device adverse events reported over the last decade. And another report by McKinsey & Company suggested that such adverse events and associated quality issues cost the medical device industry between $2.5 billion and $5 billion per year on average. Furthermore, a 2013 report by McKinsey & Company suggested that such adverse events and associated quality issues cost the medical device industry between $2.5 billion and $5 billion per year on average.
In this latest investigation, a team of leading human factors scientists from Mauro Usability Science and the Institute for Human and Machine Cognition conducted a thorough analysis of current FDA guidance regarding the design of medical devices to accommodate as wide a range of potential users as possible. They recently published their findings in a paper that links possible sources of HFE performance problems with medical devices to HFE validation methodologies within the FDA HFE guidance framework. Their paper also examines device design teams' failure to utilize HFE best practices in the design and testing of medical devices.
Critical conclusions drawn from this analysis suggest that, currently, medical devices may not be designed and validated according to the full percentile range recommended by FDA guidance and HFE best practice. The analysis also indicates that both the FDA and medical device design teams have failed to understand that designing devices to meet a specific range of user needs includes not only physical attributes, but also a wide range of percentile-based cognitive and physiological HFE performance variables. This problem is potentially causing patients who reside at the extremes of percentile distributions (i.e., those with extreme, but acceptable degrees of functional and/or cognitive limitations) to not be able to use devices successfully, which may significantly impact clinical outcomes.
