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The FDA requires that any medical device intended for multiple uses and subject to reprocessing must bear a UDI directly marked on the device itself. Here you can arm yourself with knowledge about current UDI marking guidelines and methodologies from a presentation and Q&A with our experts.

What is UDI?

UDI stands for Unique Device Identification system.

• Dictates a standardized method of coding medical devices with key identifying information.
• Medical devices sold in the United States must be logged in a Global Unique Device Identification Database (GUDID) for consistency and transparency.
• Enables traceability of devices throughout manufacture, distribution, and use.

What are the parts of a UDI code?

• Device Identifier (DI) – A mandatory, fixed portion that identifies the labeler and the specific version or model of a device.
• Production Identifier (PI) – A conditional, variable portion of a UDI.

How long does a device need to bear a UDI?

UDI must enable identification of medical devices throughout manufacture, distribution, and use regardless of handing, processing and use. A UDI is designed to protect consumers throughout the device lifecycle. Devices used only once before disposal or used multiple times by the same patient, do not require permanent UDI marks.

Does a UDI have to be on packaging and labeling or devices or both?

According to the FDA: "A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use." --- 21 CFR 801.45

Packaging and labeling may not stand the test of time. Permanent UDI marks ensure device information is always available, even when labels and packaging aren't.

Why do I need a permanent mark when there is already a UDI on my label?

UDI is the only method of effectively tracing a device to know:

• Where the device came from
• Where the device is now
• Where the device will be applied

UDI ensures adverse events (like product recalls) can be addressed quickly with minimal risk to the consumer. Remember: A direct part mark is typically the only identifier of your device after it is taken out of the package.

What are the deadlines to implement permanent UDI?

By Sept. 24, 2020 all Class I, Class II and Class III, and all other medical devices must have a permanently fixed UDI mark. The regulations were rolled out on this timeline:

• 2020 – Class I and All Other Devices: Class I devices require little regulatory control, like dental floss and gauze bandages.
• 2018 – Class II Devices: Class II devices are higher-risk devices like syringes, requiring regulatory controls to ensure safety and effectiveness.
• 2016 – Class III Devices: Class devices are the highest-risk devices, approved by FDA before release, like replacement heart valves and other implantable devices.
• 2015 – Implantable, Life-Supporting, and Life-Sustaining Devices

What is "permanent" or "direct" marking?

Direct part marking (DPM) is a process of abrading a code directly on to a device service. Unlike labels, DPM codes are not easily discarded, obsured, wiped off or degraded. DPMs ensure the availability of encoded information throughout the device lifecycle.

What is "reprocessing"?

Reprocessing is any process used to render a medical device fit for subsequent use. The process is used to remove blood, tissue, biological debris and other contaminants. Reprocessing is generally intended for devices that have repeated use on or by more than a single patient.

What is the required format of a UDI mark?

• Unlike UDI on labels and packaging, a permanent UDI mark may be provided in either:
• Human-readable format: Easily legible in plain-text format.
• Machine-readable format: Able to be interpreted by automatic identification and data capture (AIDC) technology such as barcode readers, machine vision systems and/or RFID equipment.
• What are the best practices for UDI marking?
• Choose the best marking method for your device.
• Choose a data carrier that suits your marking method and size of your device.
• Choose a process for verifying UDI mark accuracy and quality, based on currently-accepted quality parameters.

How should I apply a direct part mark?

A direct part mark is made by altering a device surface to expose a pattern in a different reflectance or color. There are a variety of permanent direct part marking methods. The most common methods are: Laser etch, electromechanical etch and dot peen.