Medical Devices
Event Problem Codes
This website covers information about the event problem codes that can be used to complete medical device reports. The event problem codes consist of patient problem codes, device problem codes, and component codes. If you are looking for evaluation codes, you can find them in the 3500A codes manual.
SPECIAL NOTE ABOUT CODES FOR MEDICAL DEVICE REPORTS (MDRs) : Please remember that only FDA-authorized codes will be accepted in mandatory MDRs for CDRH. While some CDRH codes may also appear in other coding structures, the best way to assure that you are using an FDA-authorized code is to check the codes lists provided here.
The Food and Drug Administration Center for Devices and Radiological Health (FDA CDRH), in cooperation with the National Cancer Institute Enterprise Vocabulary Service (NCI-EVS) completed an adverse event vocabulary effort that updated the older CDRH Event Problem Codes (Device and Patient Problems, reference Block F10 of FDA Form 3500A). This update was needed for the following reasons:
- Majority of codes were not defined
- Codes had ambiguous meaning and were often created for unique situations at a particular point in time
- Multiple synonyms existed for one concept resulting in confusion about which code was preferred
- No change control procedures to manage the addition, deletion or update of terms
- Limited communication with reporters regarding coding updates
- No on-line access method that assisted with automated downloading of current terms
The CDRH Event Problem Code initiative has:
- Reviewed the existing User Facility Event Problem Codes
- Updated these codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events
- Used this website to store the updated codes and tools for aiding the transition from the current to the enhanced coding system
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 concept. By having just one term represent a problem concept, the reporter should be able to more easily select an appropriate code. The reporter will also be able to review the definition that has been included for many codes as well as considering code selection within the context of a meaningful hierarchy. Note: the definitions assigned to the Event Problem Codes are not regulatory definitions. They have been added to many Event Problem Code terms to provide additional clarification.
The original coding system organized all codes alphabetically—there were no meaningful categories with relationships to one another. Patient problem codes and component codes have been organized within broad categories, but still remain in a list-type format.
The focus of the FDA CDRH/NCI EVS collaboration was on creating the Device Problem Code set as a self-contained hierarchy developed specifically to address all categories of device problems. Currently, the device problem codes are arranged in a hierarchy of six levels. We recommend that coders assign terms at the lowest level of the hierarchy. No codes from Level 1 will be accepted as allowable terms for reporting.
- Creation of educational tools to increase the likelihood of improved code use
See Coding Tools/Resource Files
- Adoption of change control mechanisms to maintain coding improvements and ensure ongoing improvement in coding quality for the future
See Requesting a New Code
- Outreach to terminology groups to promote harmonization of event problem code terminology
As part of the initiative the FDA CDRH staff has and will continue to promote the use of the event problem codes as a controlled terminology for reporting device adverse events that can be used in both regulatory and non-regulatory environments. FDA worked collaboratively with standards groups in the development of the codes and will continue to work with these groups using our change control processes.
Each FDA term now includes not only an FDA code (which should still be the preferred code added to the FDA form 3500A), but a unique NCI EVS Concept code (c-code) that allows the term to be used for any problem reporting situation. FDA is actively promoting the use of the new hierarchal code system not only for FDA Form 3500A, but in any situation involving reporting of device-related adverse events including HL7 ICSR standard, premarket studies where device event data is captured, condition of approval studies, and patient safety reporting from research groups.
- Minimize burden to manufacturers
The majority of event problem codes in the current system were unambiguous concepts that have been used to characterize reported adverse events to FDA. These codes were retained in the new system, and as a result, more than 60 percent of the current codes fit into the new hierarchical structure, obviating the need for a complete overhaul of the coding system.
