Supplement to Part IV Submissions to FDA: Risk Management and Use Errors

Additional Thoughts:

As part of your risk analysis and use error identification, you should identify the circumstances or origin of the reported use error. 

• Origins of reports of use errors, in order of likely relevance:

1. Field reported use errors: These require special attention because they were discovered while in use by users under actual conditions. That's the reason why field reported use errors are the most important.They deserve special consideration, particularly if the use error was responsible for any harm and that the use error occurs significantly more often than originally predicted. Consider performing a root cause analysis to determine why the use error occurred. Most especially consider the use or environmental conditions and who made the use error to be factored into why the use error was made. Be sure to determine which assumptions regarding use, conditions for use and predicted user characteristics were violated. 
2. Errors reported from empirical studies: These are use errors that have been observed under laboratory or other kinds of testing conditions defined by researchers. Furthermore, these use errors are from members of the expected user population(s) who have the expected requisite level of education and training. Thus in testing sessions the conditions of use including the environment have been structured and manipulated by the researchers. The results of the research and the use errors detected may be valid, but narrow in scope in both situations of use, the use environment, actual user characteristics including education and training, etc. 
3. Analysis based:
• Scenarios: Scenarios are set of connected events with a beginning, a series of possible steps or actions and an end point. They are generally derived from real world knowledge of the environment, the people involved -- their characteristics such as education, training, responsibilities, experiences, situaetc. --  and the kinds of actions they would engage with the systems and devices in development in order to accomplish a particular task. Scenarios also consider possible paths and actions that would lead to making a use error. Scenarios particularly worst-case scenarios can be an effective means for detecting possible use errors. With newly designed products and systems, this maybe one of the first means to identify possible use errors and determine their possible harm. Nevertheless, scenario-based use errors come from thought experiments and lack empirical validation.
• Brain-storming: Brain storming is an unstructured or free-form process of analysis to capture the possible use errors. Brain storming sessions can be a particularly useful means of capturing conditions and use errors that may not have been seen or consider using other methods. However use errors derived from brain storming are not based on empirical evidence. Nevertheless, those who uncover use errors by brain storming often have high levels of expertise and experience in the technical area under consideration.

Each process as its own value and every method to detect or originate possible use errors should be considered. And when reporting use errors in the submission, I suggest that where the reported use error originated should be included in the final submitted report. And a summary of where use errors originated should be included in the narrative.