Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Assimilating Use Error Analysis Into Risk Management and Product Development
Product development organizations have well-established processes in assessing potential hazards for both process and design. However, these processes do not traditionally apply to use error, therefore hazard management teams tend to treat the human component of systems in a superficial, non-formal way.Historically, Human Factors work has taken up the slack by producing formal methods of assessing use error based on sound theory of human performance and problem solving. However, these methods are typically used to assess error after the fact and do not fit well within traditional product development programs.
Additionally, formal methods tend to be heavy on theory and are not easily used by teams outside of the discipline.
By developing a formal Use Error Analysis (UEA) process that identifies potential use error during initial product design an exhaustive, predictive list of use errors can be generated. Once it is determined which errors should be mitigated, the process allows product hazard management teams to determine the probable causes of the use error which can then be directly addressed through system design or other mitigations as appropriate. Key to this process is to define use error and failure modes based on well-established error taxonomies in a manner that assimilates well into existing risk management tools and process. This formalism has been found to be easily learned by the cross-functional teams working within Ximedica’s integrated development process. It also allows the hazard analysis team to work from the same set of guidelines and uniform understanding of the work environment while promoting a healthy perspective of use error and how it fits within an overall assessment of system failure.
Ultimately, this process moves traditional risk management beyond treating the user as a causal agent of system failure and places the focus on the system or process being analyzed. Use error is treated as an instance in a causal chain of events that lead to system failure. In this manner, mitigation becomes an exercise in directly addressing more enduring system issues as opposed to trying to prevent the fleeting conditions that generally surround the error event.
Dean will be speaking comprehensively on this topic at the Human Factors & Ergonomics Society International Symposium on March 11 - click here for the event agenda.