By Beth Gibson
It has been two years since the passing of the U.S. Food and Drug Administration’s regulation for Unique Device Identification (UDI), and while the labeling requirement for Class III medical devices has long passed (Sept. 24, 2014), a second deadline has placed tremendous pressure on medical device manufacturers and distributors.
By Sept. 24, 2015, all labels and packages of Class II implantable, life-sustaining and life-supporting devices were to have hade a UDI. Corresponding data was to be submitted to the FDA Government Unique Device Identifier Database (GUDID) by Oct. 24, 2015. The September deadline also pertained to life-sustaining and life-supporting devices that are required to have UDI as a permanent direct mark if they are to be used more than once, and reprocessed before each use. Additionally, stand-alone software that is life-sustaining or life-supporting must have a UDI and human-readable dates on labels in the designated format (YYYY-MM-DD).
Many medical device manufacturers were compliant by the deadline. They also modified or established processes and standard operating procedures to maintain compliance going forward.
Implications for providers
What does this mean for buyers and distributors? While the UDI rule does not spell out any specific requirements of healthcare providers at this time, buyers and users of these medical devices could be taking action 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.
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 electronic health record (EHR), reinforcing patient safety. Product information integrated into an individual’s EHR can then be used in product recall notifications as well as to determine product efficacy and outcomes.
To address this need, healthcare providers are finding it important to build UDI utilization into their operational business plans. Areas of focus include determining their ERP and EHR system capabilities to house and handle the data, preparing for training in the clinical and materials management areas, and establishing cross-functional teams to manage projects associated with UDI utilization. Integrating product information into the patient health record will require product identification all the way down to the unit of issue or use. Providers should be working very closely with medical device manufacturers to insist on this level of product identification to make scanning these products effective and efficient.
Implications for suppliers
In a large number of medical device product transactions, a medical product distributor sits between the device manufacturer and the provider. Under the FDA UDI law, distributors will be expected to be able to seamlessly accept from manufacturers and pass to providers the same data elements associated with device identification. In pharmacy, product track-and-trace aims to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. So too, certain data elements associated with medical devices will become important to maintain between device manufacturers and end users served through distribution. Additionally, by utilizing product identifiers, including the GS1 Global Trade Item Number® (GTIN®) and other GS1 standards, distributors can leverage many of the same operational benefits that providers achieve around inventory management and improved supply chain efficiencies.
As the FDA UDI implementation timeline evolves to meet Class II and Class I requirements in 2016 and 2018, respectively , other areas of impact may come to light for manufacturers, distributors and providers. There continues to be much discussion in the healthcare industry among members of the GS1 Healthcare US initiative about the use of unique device identification and other industry standards, as well as the benefits that can be achieved over and above compliance to the FDA UDI rule. While it is important for each area of the supply chain to gain the most benefit from standards adoption, they all agree that their overarching responsibility lies in improving patient safety and providing a better patient experience. That alone seems to be more than enough of a driver to continue to move the industry forward.
Beth Gibson is senior director, industry engagement, medical devices, GS1 US. GS1 US, a member of GS1®, is an information standards organization that brings industry communities together to solve supply-chain problems through the adoption and implementation of GS1 Standards.
Class system
The U.S. Food and Drug Administration classifies medical devices based on the risks associated with the device.
- Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. (FDA example: dental floss.)
- Class II devices are higher-risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. (FDA example: condoms.)
- Class III devices are generally the highest-risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by the FDA before they are marketed. (FDA example: replacement heart valves.)