The FDA UDI Rule and Its Impact on Dentistry

Beth Gibson


On September 24, 2013, the Food and Drug Administration (FDA) passed the final rule for the Unique Device Identification System. By ushering in a new era of supply chain harmonization, the rule is aimed at ultimately enhancing patient safety and operational efficiencies within the entire healthcare industry. It includes three major requirements.

First, every medical device must be assigned a unique device identifier (UDI), and the label or package of all medical devices must include that device’s UDI in both plain text and in a format that uses automatic identification and data capture (AIDC) technology or, in other words, a barcode.

Second, the labeler or brand owner of the device must submit product information about it to the FDA’s Global Unique Device Identification Database (GUDID). Accessible online and administered by the FDA, the GUDID serves as a reference catalog for every device with an identifier.

Third, the actual device will need to be directly marked with a UDI if it is intended to be used more than once and reprocessed before each use. The FDA has allowed for a few exceptions for certain products for each of these requirements, but, for the most part, the final rule applies to the vast majority of classified medical devices.

What This Means to the Dental Profession

The FDA has issued compliance dates for medical devices to meet these requirements in a phased approach based on device risk. Class III medical devices, which include the highest-risk medical devices, had a compliance date of September 24, 2014. This was followed by a compliance date of September 24, 2015, for implantable, life-sustaining, and life-supporting devices.

Class II medical devices, which include a broad spectrum of medium-risk devices from powered wheelchairs to acupuncture needles, must be compliant by September 24 this year. Class I medical devices, which represent the lowest-risk category of products, have a compliance date of September 24, 2018.

To the FDA, the channel or market that a medical device flows through is not relevant. The FDA UDI rule applies to any medical device in any market in the United States. So, medical devices manufactured and sold in the dental industry must meet the same compliance dates and requirements as those in the traditional healthcare industry.

Therefore, the impact on manufacturers or labelers of classified medical devices, even in the dental market, is clear. Any products manufactured and placed into commercial distribution on or after their compliance date must meet the FDA UDI final rule requirement. Many dental device manufacturers are well on their way to implementing these requirements for their products.

Awareness at the Practice Level

When asked about UDI and how it might impact their practice, some dentists don’t believe it impacts them or their practice. “I don’t use classified medical devices or perform procedures that are invasive. I would refer those types of needs to an oral surgeon,” said one dentist.

Many dental providers are unaware that products they use every day, like dental floss and toothbrushes, are Class I medical devices. What about dental amalgam or an ultrasonic scaler? They are Class II medical devices. And the list goes on. While there will be a number of products dentists use every day that will be required to meet the UDI regulations, the responsibility right now is on the manufacturer or labeler of those devices.

The UDI rule does not spell out any specific requirements of healthcare providers at this time, but this may change in the future as regulations around product recall traceability, product efficacy, and product information in patient electronic health records (EHR) evolve. The “Holy Grail” of UDI utilization by providers can be achieved when this information is scanned at the point of care and made available as a component of a patient’s EHR, reinforcing patient safety at the point of care.

Product information integrated into an individual’s EHR then can be used in product recall notifications as well as to determine product efficacy and outcomes. To address this future need, healthcare providers are finding it important to build UDI utilization into their operational business plans now.

Areas of focus include working with their technology solution partners in determining their enterprise resource planning (ERP) and EHR system capabilities to house and handle the data, preparing for training in the clinical and product procurement areas, and establishing cross-functional teams to manage projects associated with UDI utilization.

The integration of product information into the patient health record will require product identification all the way down to the unit of issue or use. In anticipation of this need, providers should be working very closely with medical device manufacturers to encourage this level of product identification to make scanning these products effective and efficient.

Additional Benefits of Unique Identification

Over and above future regulatory compliance requirements, there are actions that buyers and users of these medical devices could be taking to utilize the UDI in their processes and transactions. Leveraging standardized product identifiers within the provider systems and processes has proven to reduce costs associated with product obsolescence, unit of measure ordering errors, or simply ordering the wrong product altogether. These examples are just a few that are found on the product logistics and inventory management side of an organization’s product-related activities.

So, as manufacturers of dental devices aggressively work to make sure that the products they make will be compliant by the respective FDA mandated dates, dental care providers are encouraged to begin to educate themselves about UDI and other government regulations that are being discussed with regards to the uses of this information in the future.

As these healthcare industry and regulatory discussions evolve, other areas of impact may come to light for even general dentistry practitioners. In the meantime, the opportunity exists to learn how the use of unique device identification and other industry standards can be used to achieve process and supply chain benefits over and above compliance.

It will be important for all stakeholders to gain the most benefit out of unique identification. But, the overarching responsibility they all bear lies in supporting the goal of improving patient safety and a better patient experience. That alone seems to be more than enough of a driver to continue to move the industry forward. This includes the dental profession.

Beth Gibson, senior director of healthcare for GS1 US, 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 the medical device segment, she is actively collaborating with industry to address the FDA’s Unique Device Identification (UDI) requirements for enhanced patient safety. 

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