As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are needed and can be tracked through distribution and use.

Against this backdrop, Class I medical device manufacturers are facing a final deadline to comply with the 2013 Unique Device Identification (UDI) Rule.1 The rule requires medical devices to be marked with a unique device identifier and standardized date, and for the device data to be uploaded to the U.S. Food and Drug Administration’s (FDA’s) Global Unique Device Identification Database (GUDID).

Class I devices are the last category required to meet the labeling requirements because they pose the lowest risk to patients and users. Nevertheless, these supplies have been critical and, at times, difficult to source at peak demand during the 2020 pandemic. Considering the importance of maintaining a reliable supply of these products, efforts to meet labeling requirements should be prioritized to enable the supply-chain visibility that the UDI Rule is designed to help establish.

Current Events Affecting Compliance Dates

In January 2018, acknowledging the scale of the effort and the volume of products in this final category, the FDA announced it would not enforce the September 24, 2018, UDI deadline for Class I devices until September 24, 2020, giving manufacturers a two-year extension to comply.

Then COVID happened. The entire healthcare industry has been disrupted by the pandemic, with attention and resources quickly being reallocated to address the urgent matter of public health. It is a defining moment for modern healthcare. As a result, on July 1, the FDA announced a second enforcement delay — to September 24, 2022 — for Class I devices to meet UDI requirements. The new guidance, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” reflects the agency’s updated position on enforcement after taking urgent challenges into account, allowing the industry to remain focused, for now, on labeling and tracking higher-priority (higher risk) devices.2

Two Years to Get it Right

Class I UDI implementation is no small endeavor. These products are made by companies of all sizes — some of which are manufacturing hundreds of different devices, almost all of which are subject to the rule and require UDI marking and registration in GUDID. The sheer volume of these products, and the multitude of manufacturers producing them, creates challenges in reaching critical mass across the entire industry.

Industry experts have estimated that Class I product data will double the 2.6 million device identifiers currently stored in the GUDID. The volume of data to be gathered and uploaded to GUDID is substantial, particularly for companies with multiple product lines. Once entered, the data for all those products must be maintained so that it will always be up to date and accurate.

Most device manufacturers are leveraging GS1 standards to implement the unique identification requirements. About 86 percent of UDIs currently published in GUDID use a GS1 Global Trade Item Number ® (GTIN®) for the product identifier.

Class I Medical Device Defined

The FDA defines a medical device as any item that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation treatment, or prevention of disease.” Guidance is provided on the FDA’s Web site for determining whether a product meets medical device criteria and is therefore subject to the UDI Rule.3 This is not always obvious, since Class I devices include a vast assortment of products ranging from bandages to tongue depressors and some forms of personal protective equipment (PPE).

Class I devices include many different products ranging from bandages to tongue depressors and some forms of personal protective equipment (PPE).

Rule Requirements

Under the rule, device manufacturers, reprocessors, specification developers, repackagers, and relabelers must label their products with unique device identifiers (UDIs) in both human and machine readable (e.g., barcode or RFID) formats; then, publish the information along with additional product attributes to GUDID.

A UDI is a unique numeric or alpha-numeric identification code assigned to medical devices by the labeler (e.g., manufacturer) of the device. A UDI includes two segments: a “device identifier” (DI) and “production identifier(s)” (PI). The rule also requires a standardized YYYY-MM-DD format for any date specified on device labels. In addition, reusable medical devices that require reprocessing before reuse must be directly marked with the UDI, so that the product remains traceable.

Class I devices marked with a UPC barcode on the label — such as retail products — are considered to have met the UDI labeling requirements. The UPC number serves as the UDI, which must still be registered in GUDID with the required data attributes.

Production information — or additional data such as expiration date, production date, lot/batch number or serial number, and when relevant for the device — will appear on the package label but cannot be encoded in a UPC barcode. The presence of this production information must be indicated when entering product data into GUDID.

The most time-consuming aspect of the entire GUDID registration process for most companies will be collecting the required information for each device before uploading it to GUDID. This upload can be performed internally — possibly the most practical approach for smaller companies producing fewer than 100 different products. When users log into the FDA Web site to enter the product data (using the FDA Labeler Account they have acquired from the U.S. FDA), they will be led through the questions that must be answered.

Alternatively, the process can be automated using a proprietary business-to-business interface program or performed by a third-party service provider. Every supplier should choose an approach that fits their budget, staffing resources, and number of products to be entered.

The Benefits of UDI

Broad adoption of unique identifiers, coupled with unique location identifiers such as the GS1 Global Location Number (GLN), will lay the foundation for fuller visibility into medical products’ location within the supply chain. In the healthcare provider setting, where medical products are used constantly to deliver even the most basic care, it improves patient safety by facilitating accurate tracking and removal of products that have expired or been recalled. It also provides further information that can help the medical community track a product’s effects in patient or consumer use.

Looking ahead, UDI information will provide the framework for interoperable data exchange between suppliers, distributors, and providers, as required by 2023. Fully implemented across the entire healthcare ecosystem, this interoperability will ultimately improve patient safety, modernize device monitoring, and facilitate operational efficiencies for healthcare providers.

Start Now

Compliance with UDI Rule requirements is an ongoing effort, not a onetime project. It requires coordination across a wide variety of functions within a manufacturer organization, from regulatory affairs and printing to marketing and information technology. And while other healthcare issues may seem to take precedence (a pandemic, for instance), it is no less important that providers can readily locate the medical supplies needed for patient care.

Several resources are available to help guide companies through the process. GS1 US offers an “Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI)” and a “Quick Start Guide” explaining how GS1 Standards can be applied to meeting certain UDI requirements.4,5

The FDA also offers guidance in its “FDA UDI Basics” and its “Global Unique Device Identification Database (GUDID): Guidance for Industry” resources available online.6,7

The importance of supply-chain visibility for all healthcare products became abundantly clear early in the COVID-19 pandemic. The good news is that since passage of the UDI Rule, the industry has made significant progress on improving medical device traceability. However, there is much more work to be done, especially for Class I and unclassified device labelers that may be getting a late start.

The new two-year enforcement delay provides a much-needed opportunity for suppliers to address immediate needs while continuing the necessary work to ensure that these products will be vigilantly marked and tracked through the supply chain.

UDI implementation across the entire spectrum of applicable medical products will further improve supply-chain visibility and allow the industry to better prepare and provide the best possible patient care — whatever the future holds.

References

  1. Unique Device Identification System,” Federal Register, 9/24/2013.
  2. Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” U.S. Food & Drug Administration, July 2020.
  3. How to Determine if Your Product is a Medical Device,” U.S. Food & Drug Administration.
  4. Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI),” GS1 US.
  5. Healthcare Supplier FDA UDI Quick Start Guide,” GS1 US.
  6. UDI Basics,” U.S. Food & Drug Administration.
  7. Global Unique Device Identification Database (GUDID) Guidance for Industry and Food and Drug Administration Staff,” U.S. Food & Drug Administration, June 27, 2014.

This article was written by Beth Wells, Sr. Director Community Engagement, GS1 US, Ewing, NJ. For more information, visit here .


Medical Design Briefs Magazine

This article first appeared in the September, 2020 issue of Medical Design Briefs Magazine.

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