Class I medical device companies have work to do, despite the UDI enforcement delay.

Beth Wells, Senior Director, Community Engagement

October 20, 2020

5 Min Read
Image courtesy of Shutterstock

The healthcare supply chain has seen its share of ups and downs this year. In the early months of the COVID-19 pandemic crisis, product shortages were exacerbated by a lack of supply-chain visibility. Ever since the U.S. FDA’s Unique Device Identification (UDI) Rule passage in 2013, the industry has been working on meeting rule requirements created to make the supply chain more transparent. 

Some of the most basic products that were in short supply during recent months—such as exam gloves and other PPE items—are deemed by FDA to be Class I medical devices, which are those posing the lowest risk to patient safety. Low risk or not, the crisis showed how critical these supplies are when healthcare providers could not obtain enough protective gear for their front-line workers. Supplies were short, and sourcing data was elusive. A better view of inventory throughout the supply chain would have been extremely helpful as providers scrambled to obtain necessities. The good news is that once Class I manufacturers implement UDI requirements, traceability can be vastly improved, helping healthcare providers find and obtain the products they need more easily, accurately, and efficiently.

UDI Requirements and Deadlines

Manufacturers are required under the UDI rule to mark Class I, Class II, and Class III medical device packages with a unique device identifier and standardized date and to upload the device data to the FDA’s Global Unique Device Identification Database (GUDID). Implementation is well underway for Class II, Implantable, Life Sustaining/Life Supporting, and Class III devices (compliance deadlines have already past).

Class I products are the final category facing FDA deadlines for UDI compliance. That deadline was originally set for September 24, 2018—but in July of this year, FDA announced a second, two-year enforcement delay to allow the industry to focus on more critical issues of patient care, pandemic response, and higher-risk medical device categories (Class II and Class III, which include ventilators and other life-sustaining items). FDA’s 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 these urgent challenges into account.

The enforcement delay means that Class I manufacturers can continue working to fulfill the rule requirements for two more years before facing penalties for noncompliance. However, it does not absolve the industry of its responsibility to move ahead in building the data systems to meet these requirements. In fact, work must continue unabated to implement UDI Rule requirements throughout the supply chain, even though FDA will not enforce them until September 24, 2022.

Work to Be Done

The Class I medical device category includes a broad assortment of products that might not seem like medical devices—such as cotton-tipped applicators, gauze, exam gloves, and the like—but if they meet FDA’s criteria, they are subject to the UDI Rule’s requirements. Specifically, 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,” so the definition is quite expansive. Guidance is provided on FDA’s website for determining whether a product meets medical device criteria and is therefore subject to the UDI Rule. 

Manufacturing companies of all sizes may be producing one, two, or hundreds of different Class I products. There is a great deal of data to be created and shared in order for Class I UDI implementation to reach critical mass and provide its full benefits. It is estimated that this data will double the 2.6 million device identifiers currently stored in the GUDID. Once that data is uploaded, the database must be maintained so that it will always be up to date and accurate. 

The most time-consuming aspect of the entire GUDID registration process for companies will be collecting the required information for each device before uploading it to GUDID. Users must obtain an FDA Labeler Account from FDA which they will then use to log into the FDA website and enter the product data. Once logged in, the interface leads users through a list of questions they must answer. Companies with numerous products to upload may find it worthwhile, depending on their resources, to automate this process using a proprietary business-to-business interface program or to hire a third-party service provider.

Make UDI a Top Priority

The industry has made significant progress to improve medical device traceability and address UDI requirements. There remains much work to be done, especially for some Class I and unclassified device manufacturers not yet engaged in the process. If not already in progress, these suppliers are strongly urged to begin now, without delay. UDI implementation is going to take time and involves teamwork between several different company departments such as IT, regulatory affairs, packaging, and marketing. A company that manufactures many different products will need to devote sufficient time to generate a high volume of data and coordinate the efforts of all contributors.

Improving supply-chain visibility is crucial for the industry’s readiness to meet new challenges and—critically—to navigate the ups and downs of supply and demand as effectively and efficiently as possible. Broad adoption of UDIs, combined with unique location identifiers such as the GS1 Global Location Number (GLN), will enable stakeholders to know where products are at any given time as they travel through the supply chain. Providers will be able to manage inventory and work through any problems more proactively so that their standard of care is not jeopardized by a shortage of essential supplies.

Help Is Available

FDA offers online guidance for UDI implementation in its online resources, “FDA UDI Basics” and “Global Unique Device Identification Database (GUDID): Guidance for Industry.” Information is also available from GS1 US to help companies understand how to leverage GS1 Standards in UDI implementation, including its “Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI)” and “Quick Start Guide.”

The COVID-19 pandemic has forced the healthcare industry to focus its attention on immediate crisis management, but longer-term priorities can’t be put on the shelf in the meantime. The need for better supply-chain traceability has been dramatically demonstrated in 2020 by a situation that has commanded urgent attention. It is the longer-term, proactive aspect of healthcare transformation that will help us prepare for whatever comes next—do a better job of taking care of patient needs in extraordinary times.

About the Author(s)

Beth Wells

Senior Director, Community Engagement, GS1 US

As a Senior Director of Community Engagement for GS1 US, Beth Wells is responsible for leading U.S. healthcare trading partners to actively engage, adopt, and implement GS1 standards to improve their business and supply chain operations. With a focus on providers and the medical device segment, she is also actively collaborating with industry to address FDA’s Unique Device Identification (UDI) requirements for enhanced patient safety.  

Wells has more than 30 years of experience in healthcare distributor and supply chain operations. She held numerous leadership roles focused on business growth and development at a leading healthcare distribution organization where she managed the company’s most strategic medical manufacturing partner relationships. She also supervised teams of master product data and supply chain specialists focused on identifying, developing, and managing supply chain improvement projects with both upstream and downstream trading partners. 

Wells earned her Bachelor of Science degree in Biology from James Madison University in Harrisonburg, Virginia. She currently resides in Virginia. 

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