Medical Device Problem Coding

Medical Device Problem coding is an integral part of the Device Reporting, All MIR Report Types require at least one Medical Device Problem to be entered.

Previously Medical Device Problems were part of the MW Info tab, and in the Oracle Argus Safety 8.2.2 Release Medical Device Problem Information is moved from MW Info to Product > Device Tab > Patient Problem and Device Problem Information.

MIR Report requires Patient Problem codes to be captured in the form of Clinical Sign and Health Impact, However FDA currently has only one type of patient problem codes which is currently available in MW Info dialog of the Device Tab.

Important Considerations during Medical Device Problem Coding are:

• Medical Device Problem Coding is based on Harmonized codes where an FDA Code has a corresponding IMDRF Code. Therefore Medical Device Problem Coding is required to be handled considering both US and Europe regions.
• For a MIR report to be generated there needs to be at least Medical Device problem available; It is recommended that the data entry guidelines is updated to ensure that for a Case which requires MIR Report to be Scheduled, Medical Device Problem Coding is Mandatory. This is applicable for all Report Types.