In September 2007, a system intended to assign unique identifiers to medical devices found in the United States was signed into law as part of the Food and Drug Administration Amendments Act of the same year. This system required the following information:
- A unique identifier to be placed in the label of the device unless there is an alternative location specified by U.S. FDA (Food and Drug Administration) or unless there is an exception for that particular device/s
- A unique identifier that will enable the identification of the device through use and distribution
- A unique identifier with the lot or serial number if FDA specifies
Goals of UDI System
Basically, the Unique Device Identification System intends to improve the safety of patients by being able to identify fake or counterfeit products. This system also improves the ability of medical staff to distinguish devices that have similar appearance but different functions. In addition, UDI (Unique Device Identification) system would also help in the efficiency within the medical community. In summary, the implementation of this system intends to do the following:
- Reduce errors in the medical system
- Prevent counterfeits (especially in medical products)
- Improve specific and fast recall of products
- Improve patient safety
- Standardize the data found on the label
- Improve information quality on medical device and its packaging
- Help in fast regulatory action in cases of medical devices’ reports of adverse events.
Unique Device Identifiers
There are different types of unique device identifiers. The 2 main types of UDI are the following:
Device Identifier (DI)
This identifier will provide information about the labeller, the person who causes the application or modification of the label to and of the device intending for it to be distributed commercially. This identifier will also include the specific details about the model or version of the device.
Product Identifier (PI)
Depending on the device, this identifier must provide one or more of the following information:
- The date or expiration of the specific device and/or the date of manufacture
- The lot or batch number of the device or its serial number
- Distinct Identification Code for human tissue, cell or tissue or cellular-based products that are regulated as medical devices
Now that we have identified the goals and types of UDI, let us look into how UDI works. Basically, the coded number (PI or DI) will be registered in the standards organizations. Information such as manufacturer, dates of manufacture and expiry, model or version of the device, etc. will be covered. The devices supporting a UDI system will then have to be submitted to the Global Unique Device Identification Database (GUDID). In this database, information for all the medical devices within the United States will become traceable.