Six considerations for providers to maximize the FDA UDI final rule


Jean-Claude Saghbini

healthcare industry expert

On October 24, 2015 the FDA will require medical device labelers1 to register unique device identifiers (UDIs) for implantable, life-supporting, and life-sustaining medical devices. This compliance date is part of a wider initiative that requires all medical devices to contain a UDI by 2020. Associating a unique identifier with a medical device is a crucial step toward increasing traceability, transparency, and accuracy across the healthcare supply chain.

A UDI system creates an opportunity for the medical device industry to align around a single set of standards. With a common UDI system, healthcare providers will be able to collect a large and rich set of data which, when integrated with electronic health records (EHR), can be analyzed to learn more about how medical devices, pharmaceuticals and supply choices affect patient outcomes. For instance, through comparative analytics healthcare providers can assess how a specific medical device may affect outcomes, if there is a difference between brands, and how medical devices compare to medications.

Not only can this improve patient safety, but it also has the potential to reduce the total cost of healthcare by $40-100 billion worldwide.2

Recognizing this potential, progressive health systems are investing significant organizational resources with the belief that leveraging the UDI initiative will have long-term benefits for both patients and their businesses. A UDI pilot program at Mercy Health System was implemented over six months at an initial cost of $2 million, and it helped the system reduce its inventory and generated approximately $400,000 in cost savings in its first few months of usage.

If you are a provider evaluating this path, here are six considerations as you create your roadmap:

1. Collaborate with labelers

Work with your labeler (in most cases the device manufacturer) to understand which UDI standardized format they will use and what production identifiers (e.g., expiration date, lot or batch number, manufacturing date, serial number, etc.) will be included on the device labels. Beyond that, you should consider how supplies are tracked and if there is value in including other production identifiers beyond what is required.

2. Reassess your supply chain software

Ensure your enterprise resource planning (ERP) software or materials management information system (MMIS) is set up for electronic transactions that are compatible with your labeler’s UDI standardized format, and that your software is capable of handling and storing the UDI information.

3. Evaluate and create optimal workflows

Accurate data capture is critical to realizing the benefits of UDI. Review your inventory management processes from receiving to consumption to replenishment and determine where additional data capture warrants increased investment, technology and changes to support optimized clinical workflows.

4. Consider an automated inventory management solution

Automation is needed to eliminate manual data entry and reduce errors and costs. Leading providers capture medical device usage through RFID and automatically feed this data into logistics, billing, and procurement systems that connects all stakeholders, including payors and registries.

5. Determine where your health system stands with EHR integration

Despite today’s technology sophistication, there is still limited connectivity between some hospital inventory management systems and EHR. Learn where your health system stands with EHR implementation and discuss when inventory management and supply chain software should be integrated and what resources would be needed or utilized to do so.

6. Create a cross-functional team

Educating internal stakeholders within the health system about the benefits of and rationale for UDI is essential to realize its full potential. To start, consider engaging supply chain, service line leads, IT, data analytics, operations, and of course, clinicians to help facilitate this change. Recently, Pew Charitable Trusts issued recommendations to help address challenges and encourage the adoption of UDIs. As healthcare shifts from volume to value, now is the time for providers to help their health system understand the impact of the supply chain on the total cost of care.

The healthcare supply chain is capable of so much more than eliminating waste and reducing cost. It can be a strategic asset that helps improve patient safety and reduce the total cost of care, and UDI is a crucial step. Like many changes in health care, UDI should be completely invisible to the patient, but it can play a role in helping patients receive consistently safer and more effective health care, with fewer mistakes and shorter average hospital stays, while enabling new progress in personalized medicine, customized devices, and mobile health. 3

[1] According to the FDA, in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device preprocessor, a convenience kit assembler, a repackager, or a relabeler. (page 11)
2 (page 45)
3 (page 7)