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FDA Medical Device Tracking System to Improve Patient Safety

Last month, the U.S. Food and Drug Administration (FDA) finalized a new system for tracking medical devices. It is designed to better target product recalls and improve patient safety.

As we have reported on this San Diego Injury Blog, surgical vaginal mesh and metal-on-metal hip implants have also caused problems for thousands of patients across the country over the past several years. The new tracking system would use unique bar codes to detect malfunctions with specific devices and alert the public more quickly.

As detailed by the FDA, the unique device identification system (UDI) has two distinct facets. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. It includes production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date. The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID). It will function as a reference catalogue for every device in the new UDI system.

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA plans to implement the new system in phases, starting with the most high-risk devices. Class III devices will be required to carry unique device identifiers on their label and packaging within one year. Manufacturers will have three years to act for most Class II (moderate risk) devices, while Class I devices not exempt from UDI requirements will have five years to enter the system.