Unique identification is not a new concept, as the FDA has plenty of opportunity to draw on its experiences in mandating standardized labeling requirements for the Pharma and food verticals. The ultimate success of UDI implementation will hinge on being able to get “everyone” along the supply-chain involved, from product development to patient use and beyond.

Protecting and promoting the public health is the CDRH’s critical mission, so it stands to reason that the primary beneficiary of UDI will be the collective of end-users. 

With every medical device in the field being identified and tracked through the use of standardized labeling, and with the ability to immediately access data about a specific medical device’s performance at point of care:

  • Patients will have more control over their care as detailed information about the medical devices they use becomes an integral part of their electronic medical records (EMR).

  • Patient care will be enhanced as physicians are able to make important, perhaps life-saving decisions more quickly and more accurately on the basis of medical device use data compiled in the field. Less time needed to research medical device alternatives will translate into more, quality time spent with the patient.

  • Medical devices that do not perform in accordance with established standards will be quickly and accurately identified, thus protecting the patient population by allowing manufacturers to take poor performers or defective devices off the market more quickly and efficiently. The time and resources spent on implementing and managing product recalls will be reduced, thus allowing medical device manufacturers more resources to address and improve product safety and performance.

While patient safety and the quality of care should never take a back-seat to all the benefits UDI implementation will bring, medical device manufacturers can reap important benefits of early and ongoing compliance.

The terms “mandate”, “compliance” and “deadline”, as they relate to the FDA and UDI, may not come across in a positive light for many suppliers, especially those in the SMB space, as the FDA’s push for standardized labeling may be looked upon as intrusive and regulatory. However, early adoption of UDI standards will bring the same benefits seen by companies across all industries where automatic identification and data capture (AIDC) technology has been in place for decades, thus offsetting the initial cost of compliance relatively quickly, depending on the number of devices and packaging configurations that require labeling. The ability to automate product identification and tracking has traditionally yielded these benefits among others:

  • Fewer errors and time allocated for data entry.

  • Ensures accurate product identification and tracking along the supply chain.

  • Makes JIT possible, resulting in lower inventory carrying costs.

  • Improves customer order fulfillment times.

  • Ensures billing accuracy, improves AP turnover and simplifies contract administration.

  • Facilitates timely recalls through faster, more accurate detection and reporting.

  • Can lead to counterfeit product detection through global, standardized labeling.

The cost and associated ROI of implementing a UDI database management and labeling system will depend entirely on the number of SKUs sold and shipped. Obviously, the greater the number of devices and device packaging configurations that need to be uniquely identified, the greater the cost. By the same token, the resulting savings will also be greater, thus requiring less time to earn an ROI. Once that ROI is realized, the savings should outweigh the costs, since the initial expenses associated with UDI implementation can be attributed to one-time financial and human capital costs, while the savings are recurring in nature.