MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.
Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.
To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.
In our last article, Part 5: Assessing Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and distinguishing between harms that occur as a direct result of the hazard/hazardous situation and harms that will only occur as the result of a series of subsequent events. This article addresses the other major element of risk, the Probability of Occurrence of Harm.