In 2016, the FDA released a final FDA Human Factors Guidance that explains the requirements for human factors testing of medical devices.
FDA Human Factors Guidance
The FDA released a final guidance document on the subject of “Applying Human Factors and Usability Engineering to Medical Devices.” This is a final guidance document that replaces the previous version that was released in 2000 and the draft that was released in 2011. The diagram below is Figure 3 from this new FDA guidance, and it includes references to sections 5 through 9 of the guidance document.
What’s in the new FDA human factors guidance?
The organization of the guidance is similar to an ISO standard. Section 1 is the introduction. Section 2 is the scope of the guidance. Section 3 includes definitions, and Section 4 provides an overview of the human factors process and usability engineering as these concepts apply to medical devices. Sections 5 through 9 of the guidance explain the details of the process for applying these concepts to medical devices and risk management. The guidance document includes six references to national and international standards that include human factors engineering or usability engineering, and there are 19 references to articles about human factors engineering and usability engineering at the end of the guidance document.
Adding human factors to your risk management procedure
The steps in the process for human factors engineering and usability engineering mirror the risk management process as defined in ISO 14971 except this guidance does not specify developing a risk management plan or the need to create a risk management file. Identification of hazards related to use errors is the first step. Risk controls are implemented in order to reduce the risk of harm due to use errors. The risk controls are verified and validated, typically through simulated use studies or clinical studies. Therefore, you should be able to integrate usability engineering into your risk management process by specifying that hazards should include use errors, the environment of use, and the device/user interface. The risk controls section does not need to be revised, but the verification and validation of risk controls need to include simulated use and/or clinical studies in order to verify that risk controls specifically reduce the risk of use errors. It might also be useful to specify that the environment for use should be included in simulated use studies.
Creating a Usability Engineering Report Template
Clients often ask me what they need to do with regard to human factors engineering and usability engineering for documentation in their technical file and design history file. I recommend that they create a usability engineering report based on ANSI/AAMI/IEC 62366. However, companies often do not want to purchase the standard, and they seldom have time to read and understand what the standard is recommending. Now we have a free guidance document that is available from the FDA. Therefore, I recommend that you create a template for your usability engineering report based on this new guidance. If your company makes many types of products with multiple hazard types, then you will need a somewhat generic report template. However, companies with only one or two device families should be able to pre-populate a report template with sections for specific categories of hazards that are applicable to their device family. Once you have a template, this can be used to create a usability engineering report during the design process for any new medical device you are developing.
Updating Your Risk Management File to Include Usability
For products that are already on the market, you should already have human factors engineering and usability engineering incorporated into your risk management file. If you don’t, I recommend updating your risk management file in the following ways:
update your post-market surveillance plan/risk management plan to specifically gather information about use errors related to the use environment, the user, and the device/user interface
update your hazard identification report to include hazards related to use errors
update your risk analysis to include risk controls that you have implemented to reduce the risk of harm related to use errors
perform and document verification and validation of any new risk controls that you may implement related to use errors
update your instructions for use to include warnings and precautions about use errors
develop training tools, such as videos, to demonstrate possible use errors and how to avoid them
The bulk of human factors engineering and usability engineering are documented in the risk management file. Risk management documentation is only required for FDA submissions that include: 1) software of moderate level of concern or higher, 2) De Novo Classification Requests, and 3) PMA submissions. If you have a non-software device for which you are submitting a 510(k), then you do not include a risk analysis with your submission. Therefore, the only way that the usability factors are addressed is by reviewing the simulated use validation of the device and the instructions for use. It is still critical that design teams address usability engineering, however, because identifying use errors and implementing risk controls to eliminate use errors will prevent product complaints and adverse events. If these issues are not addressed during the design of a new product, corrective actions and possibly recalls will be needed after the product launch. FDA inspectors will also identify weaknesses in your risk management activities when they identify complaints that are not addressed in your risk analysis.
Additional Training Resources for Usability Engineering
Our human factors testing webinar was recently updated by Research Collective–a consulting firm specializing in usability engineering. SYS-048, Medical Device Academy’s Usability Procedure, is compliant with IEC/ISO 62366-1 (2015). The procedure includes a template for conducting summative (validation) usability testing. We have also updated our design plan template to include usability testing elements.