Self-service dictionary loader for Medical Device repository

Self-service dictionary loader for Medical Device repository of IMDRF and JFMDA (Enhancement 36796475)

Description

The self service dictionary loading from Argus Console > Tools > Dictionary Management > Dictionary Loader is enhanced to support loading of IMDRF and JFMDA dictionaries.

Note:

You can load IMDRF and JFMDA dictionaries only from Argus Console. These dictionaries cannot be loaded from the Client-Server dictionary management tool.

IMDRF dictionary

For IMDRF dictionary, zip the Annexure A to Annexure G files for loading into Argus. The loading of files is supported with FDA code columns (FDA Code and NCIt Code), or without FDA code columns. To identify the obsolete records, the Status column in the Annexure files containing the value Retired/Not selectable is used. All other changes between the old and new IMDRF dictionaries are identified by comparing the data in the Argus and selected Annexure files used for loading.

Once the IMDRF dictionary is loaded, the latest dictionary data is used for coding devices in the following sections:

• Product > Device > Health Impact Information
• Product > Device > Evaluation / Investigation Code Information
  • Evaluation Coding – Method / Type
  • Evaluation Coding – Result / Findings
  • Evaluation Coding – Conclusion
• Product > Device > Device Component Information
• Product > Device > Medical Device Problem Coding
• Event > Clinical Sign Coding

If the case form contains IMDRF code and term that became obsolete in the latest dictionary, then the same is indicated by a red cross icon against the corresponding record, when the case is opened after loading the latest dictionary. For obsolete records, only the IMDRF code is displayed and the IMDRF term is blank thereby indicating that it needs recoding.

Device sub-components in Annexure G

Annexure G that was loaded into Code Lists > Flexible Data Re-Categorization > DEVICE_SUBCOMONENTS are moved to the standard IMDRF dictionary table, CFG_FDA_IMDRF_CODES. This is to maintain consistency in all Annexures A to G. The custom records added in the Device Subcomponents flexible code list continue to exist.

It is recommended to clean up custom records from the Device Subcomponents flexible codelist, and use standard dictionary codes and terms for coding the device component information.

JFMDA dictionary

For JFMDA dictionary, zip the Terminology Codelist XML file published by PMDA loading into Argus. Once the JFMDA dictionary is loaded, the latest dictionary data is used for coding devices in the following sections:

• Product > Device > Health Impact Information
• Product > Device > Evaluation / Investigation Code Information
  • Evaluation Coding – Method / Type
  • Evaluation Coding – Result / Findings
  • Evaluation Coding – Conclusion
• Product > Device > Device Component Information
• Product > Device > Medical Device Problem Coding
• Event > Clinical Sign Coding

JFMDA version 6.0 onwards contains currency flag with values Y or N. If the case form contains JFMDA code and term that is updated with currency as N in the latest dictionary, then the same is indicated by a red cross icon against the corresponding record, when the case is opened after loading the latest dictionary. For such records, only the JFMDA code is displayed and the JFMDA term is blank thereby indicating that it needs recoding.