Does healthcare benefit from a unified approach to item-level serialization and UDI?

Are DSCSA and UDI linked or harmonized? Should they be?

The Drug Supply Chain Security Act (DSCSA), passed in 2013, mandates the eventual use of unique codes (serial numeric identifiers, or SNIs) on each container of drug products moving from manufacturers to pharmacies and retailers—item-level serialization. [1] Unique Device Identification (UDI) is the system mandated by the FDA Amendments Act of 2007, and made a final rule by FDA in 2013, for applying the UDI to many types of medical devices, especially those that represent a high risk to human health. [2]

At a recent symposium on fake medications, a speaker was asked whether there would be some convergence or harmonization between products affected by the SNI and Unique Device Identification (UDI). To my surprise, the speaker said “no” and went on to dismiss the notion. I didn’t hear any of the dismissal because I was so taken aback by his emphatic “No.”

Convergence of DSCSA, UDI and other traceability initiatives

As has been said more than once in serialization and supply-chain security meetings, “The only products that are not counterfeited are products that no one wants.” The International Chamber of Commerce estimates the projected value of global trade in counterfeit and pirated goods to be at $1.77 trillion in 2015. [3] Pharmaceuticals and medical devices are very definitely part of this product flow. So, from an anti-counterfeiting, anti-theft and anti-diversion perspective, there are parallels between the drug and medical-device supply chains.

Also, consider what is happening in other supply chains that terminate in the hospital or retail establishments (food, food service, consumer goods, apparel, etc.). The origin and handling of all items we use, wear, ingest, etc., are becoming more of a concern to legislators, regulators, companies protecting their brands, and consumers/patients. This information is becoming more available and expected in our interconnected lives.

First thing’s first

There is a natural progression or maturity of capabilities and uses within any supply chain as it undergoes standardization of any sort. The GS1 organization, which is involved in the implementation of both UDI and SNI, proposes an “Identify, Capture and Share” process for dealing with these identity data.

Both DSCSA and UDI specify an equivalent to “Identify,” but not explicitly “Capture.” Having said that, in the case of DSCSA, there is a “Share” step, which, if partners are to verify the shared data, they also need to implement the non-mandated “Capture” step. Again, in order to be ready to get the most out of the new information in the barcodes (both DSCSA and UDI) and Transaction Information/History (DSCSA), it is best if companies and hospitals get their [data] house in order. That means identifying their source of master data (Product, Entity and Location), securing those sources, and addressing the stability of that data over time.

The difference between DSCSA and UDI is in the level of identification (product, Lot or Serial Number) and in the area of traceability. Medical device supply chains are setting the foundation for stable information to be available about medical device products. Once accomplished and matured, supply chain participants will naturally look to take advantage of traceability potential to better effect recalls; identify counterfeit, diverted and stolen products; and provide essential information to meet FDA’s National Medical Device PostMarket Surveillance System, thereby reducing patient risk from faulty medical devices.

Trust but verify

Serialization, in and of itself, provides for an added layer of trust between trading partners. Serialization provides a new level of accuracy in verifying whether a trading partner does indeed deserve payment, reimbursement or credit for product held, returned or shipped. Whereas currently it might require travel to a trading partner’s site to perform physical inspections, serial numbers along with other source data allow trading partners a less expensive way to verify their customer’s or supplier’s business assertions.

The answer is “Yes”

So, the real answer to the question that was asked at the symposium is “Yes,” DSCSA and UDI are related and can be harmonized. When will it happen? When the healthcare provider community has caught up a bit and attempts to make some sense out of information available on all products that they purchase, manage, and dispense or administer.

Also, as we consumers and patients start to expect the healthcare community to provide the same level of information and access we get from our increasingly connected world.

• “2015 Product Security Report,” Pharmaceutical Commerce, May/June 2015, pp 16-19.
• “FDA finalizes a new system to identify medical devices,” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm, (accessed June 8, 2015)
• International Chamber of Commerce/BASCAP, Estimating the Global Economic and Social Impacts of Counterfeiting and Piracy (2011).

ABOUT THE AUTHOR

Robert Celeste is the founder and managing partner of RC Partners LLC (Newtown, PA www.rcpartners.biz), a consultancy assisting healthcare product manufacturers in dealing with strategic issues on product traceability, serialization and regulatory compliance. For the past 13 years, he has been the Senior Director, Healthcare of GS1 US, the group within the GS1 global organization that is establishing industry standards for both item-level serialization for pharmaceuticals and unique device identification (UDI) for medical devices. Prior work includes business process reengineering in the pharmaceutical, chemical, banking, retail and aerospace industries.