Manage the IMDRF Dictionary

Set up and manage the International Medical Device Regulators Forum (IMDRF) dictionary for coding device-specific adverse events.

Sections in This Article

About IMDRF Administration

To enable working with the International Medical Device Regulators Forum (IMDRF) dictionary codes, you must activate the IMDRF Dictionary in your vault.

Vault Safety device-specific adverse event coding includes all seven annexes from the IMDRF dictionary, which are detailed as follows:

  • Annex A: Medical Device Problem
  • Annex B: Type of Investigation
  • Annex C: Investigation Findings
  • Annex D: Investigation Conclusion
  • Annex E: Health Effects - Clinical signs and Symptoms or Conditions
  • Annex F: Health Effects: Health Impact
  • Annex G: Medical Device Component

Activating the system-managed dictionary, which is regularly updated, is fast and easy.

Prerequisites

An administrator must Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.

Add the IMDRF Dictionary

  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select Create.
  3. On the Create Dictionary page, select IMDRF Device Codefrom the Select Dictionary Type picklist.
  4. On the Create IMDRF Device Code page, in the Name field, enter a name for the dictionary.
  5. Select Save.

Result

Your system has been updated to use the centralized IMDRF dictionary.

Update the IMDRF Version

When a new central IMDRF dictionary version becomes available, an administrator must activate the new version.

Note Vault Safety currently supports only the 2022 dictionary version. A new version will be available after it is released in March 2023.

  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select IMDRF Device Code Dictionary from the table.

    The IMDRF Device Code Dictionary page appears.
    When the list of available IMDRF versions is out of sync with the server, you will see the following notification in the Active IMDRF Version field:
    The list of available IMDRF versions is out of sync with the server. Please sync the IMDRF versions to update the list.
  3. To sync the list of available IMDRF versions, perform the following steps:
    1. Open the All Actions (All Actions) menu.
    2. Select Fetch Dictionary Releases.
      This action retrieves any new central IMDRF dictionary versions.
  4. To activate a new IMDRF version:
    1. Select Edit on the IMDRF Device Code Dictionary page.
    2. In the Active IMDRF Version field, select the dictionary version from the picklist.
    3. Select Save

Result

You will receive a notification that the system is importing the selected version of the IMDRF Device Code Dictionary. When import is complete, the IMDRF Device Code Dictionary status becomes Active. New Cases default to coding from the latest active IMDRF Version.

Note Existing Cases already being processed will not be impacted by the new IMDRF version.

View the Active IMDRF Device Codes

To view a list of the active IMDRF Device Codes, go to Business Admin > Device Codes.

Select any record to view its Device Code Type, as well as the following Level 1, 2, and 3 values:

  • Concept Code
  • FDA Code
  • IMDRF Code
  • Definition
  • Term

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