Elimination not Mitigation: The confirmed role of Human Factors from the FDA
After 5 years as a draft document and a significant amount of industrial feedback and discussion, this month the US FDA has finalised their much anticipated guidance document on Applying Human Factors for Medical Device Design. There are some notable additions and changes but what do these documents really mean for usability engineers and medical device designers?
For anyone engaged in usability testing for medical products there are probably no huge surprises in the new document. The FDA has placed more emphasis on identifying critical tasks; those steps that could result in serious harm or death if performed incorrectly. The guidance highlights that whilst the device risk assessment is a good starting place for identifying critical tasks, the process should be dynamic and the list will change through the formative testing process. Risks related to critical tasks may be designed out as the product evolves, likewise developers should be aware new critical tasks may be identified as the user interactions are better understood. This reiterates the value of viewing human factors as an integrated iterative approach to design and not a specific activity or a checkbox procedure.
The guidance also includes an interesting change of semantics around addressing use-related hazards. The objective of applying HF principles has been redefined as working towards the ‘elimination or reduction’ of use-related hazards, having previously described as a form of ‘mitigation and control’. This simple change of language underlines the FDAs preference towards designing out use-related hazards wherever possible. This perspective is aligned with the risk management hierarchy of options described in ISO 14971. The guidance is very clear that, whenever practical, a design change should be made to eliminate use-related risk and reduce any reliance on the user to remember information or knowledge gleaned from instructions or labelling.
Other additions can be found in the guidance related to data collection and analysis. Of note the guidance drives home the fact FDA wants to see in-depth qualitative data and the use of open-ended questioning to establish root causes when errors occur.
FDA has also released two new draft guidance documents related to HF this month. These documents include a list of device types that should have human factors data included in premarket submissions (effectively an FDA “high priority watch list”) and a dedicated explanation of the HF studies and recommended approach for combination devices. The latter suggests that studies should be designed, in essence, to trial the products in real-life circumstances (or as much realism as feasible).
What we can see here is that FDA, understandably, is focussing its submission requirements on safety and the effective use of devices. Whilst this is of the utmost importance, applying human factors principles can provide many other benefits to the design of products and systems. Human Factors can help to increase satisfaction and desirability of products and devices which ultimately have a strong influence towards compliance and adherence of device use.
At Kinneir Dufort, we pride ourselves in our holistic approach to human factors, ensuring not only the regulatory imperatives are fulfilled but also working with our clients to maximise the ROI that can be gained through a user-centric design process.
For more information from our Human Factors team please contact Dr. Ian Culverhouse
Chris White, Senior Human Factors Consultant at Kinneir Dufort