Common Considerations for Coding Information

Consider the following points to add or update the coding information for Medical Device Problem, Health Impact, Clinical Signs, and Evaluation/Investigation:

• Medical Device, Patient Problem codes and Evaluation codes were part of the Product > Device > MW Info tab, are moved to Product > Device > Patient Problem and Device Problem Information starting Oracle Argus Safety 8.2.2 release. The Patient Problem codes are retained in the Product > Device tab to view any legacy data if present, but data entry is longer allowed.
• Device Coding is done only by invoking the look-up that displays both the FDA and IMDRF codes for Medical Device Problem Coding and Evaluation/Investigation Coding. Only the IMDRF codes are displayed in Health Impact Coding, Clinical Sign Coding, and Device Component Coding.
• The decode values are not displayed for obsolete codes. Coding User/Data Entry User is expected to recode such data against the latest IMDRF repository.