The Food and Drug Administration announced a final rule Sept. 20 for the Unique Device Identification system designed to provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety, according to a news release. The FDA has worked closely with industry, clinicians and patient and consumer groups to develop this rule.
UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices and facilitating medical device innovation, Jeffrey Shuren, MD, JD, director of the FDAs Center for Devices and Radiological Health, said in a news release.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier also will include production-specific information such as the products lot or batch number, expiration date and manufacturing date when that information appears on the label.
The second part is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database, which will serve as a reference catalogue for every device with an identifier. This device information center will not store any identifying patient information.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
Once fully implemented, the UDI system rule is expected to benefit patients, the healthcare system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It also will provide a clear way of documenting device use in electronic health records and clinical information systems.
In general, high-risk medical devices (Class 3) will be required to carry unique device identifiers on their label and packaging within one year, and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years add identifiers and submit information for most Class 2 (moderate-risk) devices. Manufacturers of Class 1 devices not exempt from UDI requirements will have five years to comply with the rule.
UDI details: http://1.usa.gov/sSfc7S