The primary distinction between a Unique Device Identifier (UDI) and a barcode in medical device labeling is that the UDI is a standardized identifying number assigned to each medical device, whereas a barcode is a graphic that can be scanned and read by a barcode reader or scanner.
Device Identifier (DI) and Product Identifier (PI) are the two parts of UDI. DI is a fixed proportion that helps in identifying a specific device model. Device manufacturers assign the DI. It is distinctive to a particular device model.
DI consists of the following parts:
- Device labeler identifier: It is a specific code that is assigned by the FDA to the manufacturers or labelers
- Device identifier: This code helps in recognition of a specific device model
- Version or model number: As the name suggests, this helps identify the model or version number of the device
- Catalog number: This code helps in matching the device in the manufacturer's catalog
PI, on the other hand, is a variable proportion of UDI. It provides identification of a specific production unit or batch of the device. PI is an essential part of UDI as it helps track specific production units or batches of devices, thus, making sure that the device is being used within its recommended shelf life.
PI consists of the following parts:
- Serial number: A specific number assigned to every individual device within a production unit or batch.
- Lot number: A unit number assigned to a particular batch of devices
- Expiration date: The date after which the manufacturer no longer guarantees the medical device's safety or effectiveness, formatted as a year, month, and day (YYYY-MM-DD). It is also known as the "use by" date or the "do not use after" date.
- Manufacturing date: The date on which the device was manufactured, formatted as a year, month, and day (YYYY-MM-DD).
- Other information, such as the manufacturer's date, address, country of manufacture, device version, and model number
Barcode
Barcode is an illustration of the data. It can be read using a scanner or a barcode reader. In terms of medical devices, a barcode is a graphical representation of a UDI. Barcode is printed on the labels or packages of the device and enables health professionals and authorized Regulatory personnel to quickly get all the specific information about the device.
The following reasons are why barcodes have to be implemented:
- Identifying and tracking devices: This helps users track not only the device but also access information regarding its indications and contraindications of use. It reduces the risk of misdiagnosis, medication errors, and adverse effects
- Inventory management: Barcodes help identify the location and number of devices available in a healthcare facility's directory. This minimizes the risk of shortage and keeps track of the overstocked items
- Quality control: Production and distribution of devices can be tracked using barcodes so that any defects or problems in the device can be readily identified. This ensures safety and quality when being used in patient care
- Regulatory compliance: Some Regulatory bodies, such as the Food and Drug Administration (FDA) and European Union (EU), have mandated the use of barcodes for easy tracking and identification
Barcodes have made it possible for healthcare professionals to quickly identify and access crucial information about the devices they use. This helps to improve patient safety and the standard of care.
Key Differentiating Points Between Barcode and UDI
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UDI |
Barcode |
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Readability |
Human-readable |
Machine-readable |
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Purpose |
A standardized identification code is assigned to every medical device |
A visual representation of data that can be scanned and read |
|
Components |
As explained above, it has two parts, DI and PI, each having their unique purpose |
It is a graphical representation of UDI |
|
Use |
Used to identify and track a specific device throughout its life cycle |
This is a primary tool used to quickly access UDI and other device-related information |
|
Location |
UDI appears as a series of codes on the label or package |
This is represented graphically in the form of lines with different gradations on the device label or package |
|
Format |
It follows a specific format as mandated by the respective Regulatory bodies |
It can be encoded in various forms, such as 1D or 2D |
A barcode will be used in conjunction with a UDI. By using a barcode in conjunction with the UDI, healthcare providers can directly access key details about the device, such as its intended use, contraindications, and potential side effects. Through a reduction in healthcare-related errors, barcoding serves to increase patient safety.
Overall, while the use of a barcode in conjunction with a UDI on medical equipment is not always mandatory, it is frequently suggested to improve patient safety and the quality of care.
To get accurate barcoding and UDI enabled on your medical device labels, consult Freyr.
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