PLATFORM
UNIQUE DEVICE IDENTIFIER
UNIQUE DEVICE IDENTIFIER
The Unique Device Identification System, commonly referred to as UDI, is an Food and Drug Administration (FDA) rule that requires medical device labelers to mark medical packages
and devices with a unique barcode. These labels aid supply chain and healthcare professionals in accurately identifying of medical devices during transit and use.
UNIQUE DEVICE IDENTIFICATION
The responsibility for UDI compliance falls largely on device labelers, who must include a unique device identifier on all non exempt medical devices and packages.
UDI barcodes are composed of two parts. The device identifier (DI) indicates the labeler and device model, while the production identifier (PI) may indicate batch number,
serial number, manufacture date, or expiration date. The FDA’s final rule includes several exceptions and alternatives for certain devices, in order to minimize the cost of burden placed on labelers.
UDI SYSTEM
An UDI comprises of
A UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information
A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable to the packaged devices
Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself. Device companies must submit information about the devices to the GUDID
(pronounced “Good ID”).
WHY WAS UDI CREATED?
The Unique Device Identification System will benefit healthcare providers, manufacturers, and individual consumers by enabling:
Faster recalls
A reduction in medical errors
More informed patient treatment
Improved inventory management
Doctors to spend more time with patients
A reduction in counterfeit medical devices
Faster discovery of flawed medical devices
A better assessment of device performance
The creation of a world-wide medical device identification system
UDI BENEFITS
Improve incident reporting
Reduces recalls
Reduces medical errors
Fights against falsified devices
Improves purchasing and waste disposal policies
Improves stock-management by health institutions and other economic operators