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The FDA Center for Devices and Radiological Health, in collaboration with the National Cancer Institute Enterprise Vocabulary Service, launched a Website (http://tinyurl.com/mlptu7) updating its coding system for reporting adverse events related to medical devices. The new system aims to improve overall report quality, facilitate manufacturer reporting, and enhance the FDA’s response capability. The Website provides updated codes and advice on transitioning to the new system. Old codes will no longer be accepted starting April 2, 2010.
The Safe Medical Devices Act of 1990 mandated that user facilities report device-related deaths to both the FDA and the manufacturer. Device-related serious injuries must be reported to the manufacturer or to the FDA if the manufacturer is unknown. With no quality control mechanisms in place, inefficiencies had plagued the FDA’s current medical device reporting system. According to the agency, the following concerns necessitated the changes:
• Most codes were undefined
• Code meanings were ambiguous and several were created for unique situations
• One concept might have multiple synonyms, causing confusion about the preferred code
• No procedures existed for adding, deleting, or updating terms
• The agency had limited communication with reporters regarding coding updates
• Current terms were not accessible online and could not be downloaded automatically.
Under the new system, one term refers to one device, and component codes identify specific device parts. Additionally, individuals reporting adverse events can access code definitions and hierarchies. These modifications simplify code selection, enhance report accuracy, and maximize efficiency. The FDA believes that the new Website and quality control mechanisms will ensure continued progress going forward.