Submission of the Human Engineering File to the FDA and Other Regulatory Bodies: Part IV

Section 5: Analysis of hazards and risks associated with use of the device

This section is one of the most important sections of your submission. Your narrative should have both a summary of your findings and highlight any notable findings from your risk analysis and include any important steps taken to mitigate risks. 

5	Analysis of hazards and risks associated with use of the device Potential use errors Potential harm and severity of harm that could result from each use error Risk management measures implemented to eliminate or reduce the risk Evidence of effectiveness of each risk management measure

Risk assessment and management for human engineering for medical devices focuses on the identification and management of use errors. This is defined in IEC 62366 (part 1).  It is valuable for representatives from human engineering to be a part of the risk management team because of the additional insights that experienced human engineering professionals can bring to the process of identifying, managing and mitigating risks. However, the specific focus of the human engineering file with respect risk management is on use errors.

Narrative should be both a summary and a means to highlight events and areas of specific importance. This section can be relatively brief, but include the following information.  

Potential Use Errors, Identifying Harm and Severity of Harm

Identify the number of use errors discovered categorized according to their level of harm/severity. Any use errors categorized as high or critical should be highlighted. Be certain to include the method or methods used to identify and categorize potential use errors: this could include methods such as general system analysis, scenarios, field data, etc. 

Risk Management Measures Implemented to Eliminate or Reduce the Risk

Once you've identified the potential use errors, discuss what was done to mitigate or eliminate them. (Of Note: Root cause analysis is a particularly effective method for understanding use errors and correcting them.)  In the narrative you can make general statements regarding what was done to manage use errors of medium risk and lower. For High and Severe risk use errors, the narrative should include the specifics of how these risks were managed. Risk management can include anything from changes in design, system error trapping and error prevention measures to updates to instructions.

Evidence of Effectiveness of Each Risk Management Measure

Finally, you will need empirical data to demonstrate that the use errors identified have been properly addressed. That will require testing with members of the targeted user population. Your narrative should include a summary (abstract) of the study or studies that you performed. And be sure to provide clear references to the documentation included in your submission. 

Note: if your targeted user population is particularly narrow and tightly specified, consider including other members from a wider group. For example, if the targeted group consists of ICU nurses, consider including general hospital RNs in your user testing group. All too often, medical devices intended for one highly trained group often appear for use by others who may be technically astute but lack the specific training of the highly trained group.

A Word to the Wise ...

You should show that your human engineering program assessed risks, identified use errors and mitigated use errors long before reaching verification and validation testing. This should have been addressed in your formative research and by periodic testing before reaching the Verification and Validation stage of testing. V & V should not be the place to uncover use errors. It should be the place that validates all of the work you've done up to that point. Now, it's likely that V&V will uncover some areas of concern, but these should be relatively minor and addressable in a relatively easily. If you have discovered numerous problems at the point of V&V, then you have a problem with your human engineering process and revamping that process should become a major focus of your organization.