Inclusion in Argus Safety 8.x of FDA Adverse Event Codes as per FDA CDRH eMDR System Enhancements

(Doc ID 2363145.1)

Last updated on FEBRUARY 21, 2018

Applies to:

Oracle Argus Safety - Version 8.0.1 and later
Information in this document applies to any platform.

Goal

The Center for Devices and Radiological Health (CDRH) published upcoming Electronic Medical Device Reporting (eMDR) system enhancements on 11-Dec-2017.

This included the list of FDA Adverse Event codes to be used in section F10 (Event Problem Codes) and section H6 (Event Problem and Evaluation Codes) of the eMDR report in order to be harmonized with the IMDRF Adverse Event Reporting Terminologies.

The eMDR System Enhancements page has details on updates to FDA Adverse Event Codes.
This is the link to the current and future MDR Adverse Event Codes
The list contains new codes and inactive codes that are not accepted in eMDR from April 2018.

This document provides a temporary solution to the updated eMDR requirements until it is provided as a part of the standard Argus product offering which is logged as enhancement request 27577310 - eMDR:Update the device problem codes used for F10, H6 as per DPC hierarchy

The temporary solution covers the following:

  • Inserts new Device and Evaluation codes to the factory data (CFG_MEDWATCH_CODES table)
  • Drops existing codes in CFG_M2 table for Device and Evaluation and inserts only valid codes as per latest FDA CDRH eMDR requirements

The temporary solution does not provide the following:

  • Scripts are not provided to update the Term description or Definition for the existing records as only the codes are used in the eMDR reports
  • Scripts are not provided to mark a term as Inactive in CFG_MEDWATCH_CODES, the current table structure does not have this capability. The inactive codes could be renamed with a prefix or suffix to indicate they are inactive
  • No changes are done to Patient codes as there are no New terms or Inactive terms

 

Solution

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