How has this initiative improved the CDRH Event Problem Codes?
The original coding system had not undergone systematic review since its original inception and did not include mechanisms to promote ongoing quality improvement. The FDA CDRH/NCI EVS collaboration provided the resources to perform a systematic review of the current codes that resulted in improvements to the coding system with minimal burden to reporters, including: • Specific improvements to patient and device problem codes and 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 During the analysis of the original system many vague, redundant terms were identified in the device and patient problem codes. These terms had been added on an ad hoc basis over the life of the coding system. Under the new coding system, CDRH has designated a preferred term that represents a unique device, component or patient problem conc
