The International Standard AAMI/ISO-14971 "Medical devices - Application of risk management to medical devices" provides for continuing evaluation of the risk profile of the device following production: “The manufacturer shall establish and maintain a systematic procedure to review information gained about the medical device or similar devices in the post-production phase. The information shall be evaluated for possible relevance to safety, especially the following:

a) if previously unrecognized hazards are present;

b) if the estimated risk(s) arising from a hazard is no longer acceptable;

c) if the original assessment is otherwise invalidated.“

However, the standard is silent on the management of risks associated with change.  Changes that may affect the risk profile of the device include changes in the production process, changes in the design of the device or changes in the way the device is used (user or manufacturer driven).  The changes may be made as a result of the identification of previously unanticipated hazards and under severe time constraints.  While such changes may not be deemed significant enough to require formal revalidation, they could result in interactions that have the potential to cause new unanticipated problems and hazards. Indeed, anticipating interactions and related hazards following changes is far from intuitive in the case of complex engineered products such as medical devices.  This paper presents a practical approach for using and modifying the initial device risk analysis, with the express intent of identifying the full extent of the impact of changes in production process, design or usage.