The Unique Device Identification (UDI) system was created with a clear and necessary goal: to improve patient safety by enabling accurate identification and traceability of medical devices throughout their lifecycle. In theory, UDI should allow manufacturers, regulators, and healthcare providers to quickly identify affected products during a recall and take appropriate action.
To the industry’s credit, progress has been substantial. UDI adoption continues to expand, more recall notices include UDI data, and standards continue to mature. From a regulatory perspective, much of the foundational framework is now in place.
Yet inside healthcare organizations, recall workflows remain overwhelmingly manual.
The reason is not a lack of effort or awareness. It is a mismatch between how UDI was designed to function and how healthcare delivery actually operates.
Where UDI Works Well
UDI has demonstrated clear value in well-controlled environments. For implantable devices, UDI capture is well established and highly effective. These products are typically scanned at the point of care, documented in the patient record, and retained as part of the permanent clinical history. When a recall occurs, health systems can identify affected patients with a high degree of accuracy and respond quickly.
In these cases, UDI is functioning exactly as intended.
Where the Disconnect Begins
Healthcare delivery environments were not designed around universal UDI capture.
Unlike manufacturing or distribution settings, hospitals operate across decentralized, fast-paced workflows. Products move through multiple channels – central supply, inventory centers, procedural areas, and clinical units – often being opened, redistributed, or consumed without any requirement to scan or retain a device identifier.
As a result, even when UDI exists upstream, it is often lost once a product enters routine clinical use.
A common example illustrates this challenge.
A box of adhesive bandages or gauze pads may arrive with UDI information at the packaging level, but once opened, distributed, or transferred between locations or regions, that data is rarely retained during routine use.
Weeks later, a recall is issued.
Even when the recall includes UDI or GTIN information, the health system has no practical way to determine where individual units were used. At that point, recall teams must rely on purchase history, distribution records, and manual investigation – not UDI.
This is not an exception. It is the norm.
Why UDI Alone Is Not Enough
This gap does not reflect poor compliance or resistance to change – it reflects the reality of today’s healthcare supply chains.
Most health systems were not built to consistently capture UDI at the point of use for non-implantable products, retain that information after packaging is removed, or connect it across inventory, clinical, and recall systems. As a result, organizations still rely heavily on catalog numbers, lot numbers, and purchase history when responding to recalls.
Even when UDI is included in recall notices, it is often not actionable on its own. Without the infrastructure to capture, store, and link UDI data across systems, its full value cannot be realized, and recall response remains labor-intensive and largely manual.
What the AHRMM Learning UDI Community Work Group Found
These realities were reflected in published findings from the AHRMM (Association for Healthcare Resource & Materials Management) Learning UDI Community’s UDI Impacts on Recall Management Work Group, which examined how UDI is used in recall processes across healthcare organizations.
The published analysis highlighted several consistent themes:
- Recall communications lack standardization
- Key data elements are often incomplete or inconsistent
- UDI is not always included, and when it is, may not be actionable
- Manual effort remains extensive
- Operational burden remains high
The published analysis suggests that while UDI has significant potential to strengthen recall management, its impact depends on how recall data is communicated and whether healthcare systems are positioned to operationalize that data effectively.
UDI is necessary, but not sufficient.
The Real Gap: Infrastructure, Not Intent
The core challenge is not awareness or willingness. It is infrastructure.
Most healthcare organizations were not built to consistently capture UDI across all product types, maintain that data as products move through clinical workflows, associate it with patient encounters for non-implantable items, or retrieve it efficiently during a recall.
Until those capabilities exist, recall teams will continue to rely on manual processes, institutional knowledge, and risk-based decision-making to ensure patient safety. This is not a failure of intent, but a reflection of the reality of applying modern identification standards within legacy systems that were never designed to support them.
A Practical Path Forward
Progress will not come from mandates alone. It will require alignment across manufacturers, regulators, distributors, and providers.
Meaningful improvement depends on greater consistency in recall data, broader use of structured and machine-readable formats, better integration between supply chain and clinical systems, realistic expectations for how UDI can be operationalized, and continued collaboration across the healthcare ecosystem.
Most importantly, it requires recognizing that having UDI data is not the same as being able to act on it.
Conclusion
UDI is a foundational element of improving medical device traceability and advancing patient safety. Its success with implantable devices demonstrates what is possible when the infrastructure exists to support it.
However, for many non-implantable and high-volume products, today’s healthcare systems are not yet equipped to operationalize UDI in a way that meaningfully improves recall execution.
The path forward is not about abandoning UDI. It is about building the systems, workflows, and standards that allow it to function as intended – not just in theory, but in practice.
Until then, recall management will continue to rely on the expertise, judgment, and manual effort of the professionals who perform this work every day.
Author Note: The views expressed in this article are the author’s own and do not necessarily reflect the views or policies of Mayo Clinic.
Article by:
Amy Conway, Enterprise Recall Analyst, Mayo Clinic
Contributor, AHRMM UDI Impacts on Recall Management Work Group
Amy is the Enterprise Recall Analyst for Mayo Clinic Supply Chain Management, with 10 years in the organization and more than 30 years of experience in manufacturing and supply chain operations, and a founding member of the Recall Management Interest Group (RMIG).
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