FDA tracks medical device problem via new code Web site

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.