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.