FDA tracks medical device problem via new code Web site

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The FDA Center for Devices and Radiological Health (CDRH), in cooperation with the National Cancer Institute Enterprise Vocabulary Service completed an adverse event vocabulary effort that updated its event-problem codes. A Web site was launched this month to track updates to these problem codes when reporting adverse events related to medical devices.

According to the FDA, April 2 is the target date to reject all inactivated and retired codes.

The event-problem code initiative reviewed and updated existing codes to reduce the manufacturer reporting burden, improve adverse event report quality and improve FDA’s ability to respond to device-related adverse events.

According to the agency, the collaboration resulted in improvements to the coding system, including:

  • Improvements to patient and device problem codes and the inclusion of component codes to clarify the part of the device associated with the event;
  • Improvements to code descriptions, definitions and structure to improve the effectiveness of the terms for identifying safety signals;
  • A Web site to store the updated codes and tools for aiding the transition from the current to the enhanced coding system;
  • Creation of educational tools to increase the likelihood of improved code use;
  • Adoption of change control mechanisms to maintain coding improvements and ensure ongoing improvement in coding quality for the future; and
  • Outreach to terminology groups to promote harmonization of event problem code terminology.