FDA Site Aims to Ease Problem Codes

The Food and Drug Administration has launched a new Web site to post updates to problem codes used when reporting adverse events related to medical devices.

There are a number of different classes of problem codes associated with the reporting process when medical devices may have caused or contributed to serious injury or death. Patient problem codes, for instance, include signs, symptoms, syndromes or diagnoses. Device problem codes describe device failures or issues related to the device that were encountered during the adverse event.

The new FDA Web site will make modifications to problem codes available to all entities that must report adverse events and will fully describe the codes. The FDA is making updates to problem codes and will reject all inactivated or retired codes submitted after April 2, 2010.

The site also explains a joint project between the FDA and the National Cancer Institute to make improvements in the problem code and reporting processes. The site is available at fda.gov/MedicalDevices/Safety/ReportaProblem/EventProblemCodes/default.htm.

--Joseph Goedert