Make an Ontology for the Medical Device Evaluation Code
In the United States, adverse events related to medical devices are required to be reported to the Food and Drug Administration by device manufacturers and user facilities. The collected information is then used to help the Food and Drug Administration take action to assess risks and avoid the recurrence of future and related adverse events. Device evaluation codes are currently used to report adverse events, but the current codes are not meaningfully categorized, in some cases they are redundant or insufficient, and there is often no clear way to assess risk control methods from the event information gathered. I am working on a new approach to the development of an ontology for the Food and Drug Administration adverse event/failure collection and classification system. The concept is to use a failure modes, mechanisms and effects analysis approach to map all possible failure mechanisms of a medical device to failure modes. The failure modes correspond to the event codes which will be reported by the user and the manufacturer. For each failure mode event code, a hierarchical breakdown of the device failure mechanisms is given along with likely environmental and operating stress causes. This hierarchical structure of codes can then be used to improve the performance of the surveillance programs, to classify failures and identify root causes, and to provide guidance and clarity to the reporters.