MEDIcept is presenting this ongoing series of articles focused on the 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, maintain compliance with risk management standards.
Our team at MEDIcept, plans to use these articles to capture best practices, explore the more challenging aspects of maintaining risk management systems over the long term, and 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 3: Using Fault Trees to Focus and Simplify Risk Analysis), we described the basic approach for conducting a Fault Tree Analysis (FTA) and the benefits of using FTA to conduct a comprehensive analysis of the causes of device failures and use errors. We also identified a few weaknesses of the FTA approach – i.e., its structure can be un-wieldy, and there is no efficient way to track the implementation of needed mitigations or document that you’ve verified that the mitigations are effective. These weaknesses are two of the strengths of the FMEA risk analysis format. Therefore, this article describes an approach for transferring risk information from a completed FTA to an FMEA so that you will be able to take advantage of the strengths of both.