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Unique Device Identification - A Hot Topic in Healthcare

Unique Device Identification (UDI) took center stage at this year’s AHRMM 15 Conference. In the hallways and in sessions, including my panel session on the topic, hospitals, regulators, solution providers and suppliers discussed the obvious benefits of having consistent, accurate and unique identifiers for devices and pharmaceuticals to ensure better tracking throughout the healthcare supply chain to reduce counterfeiting, speed recalls and improve post-market surveillance. With the UDI regulation for devices, FDA’s implementation of the Drug Supply Chain Security Act (DSCSA) and The Joint Commission tissue tracking all in full force this year, in addition to unique ID data capture requirements proposed under Meaningful Use (MU) Stage 3, many hospitals and suppliers are working hard to not only comply, but excel in this incredible time of technology and change. The industry is in the midst of transformation as it learns to harness and hone tremendous amounts of data to propel accuracy, safety and security in the nation’s healthcare system, while also meeting tight regulatory deadlines.

Those who incorporated the UDI into their information systems for last year’s Class 3 implant requirements are reaping the benefits of accurate, consistent product information. Others still have to catch up. AHRMM attendees stated, for example, that they are not aware of all the UDI requirements, even the ones providers are responsible for, such as storage of the entire UDI, including production identifiers, for retrieval in adverse event reporting. Proposed MU Stage 3 requirements for Electronic Health Records will provide the software enhancements to make this possible for implanted devices as well as document in registries and support value analysis. The industry as a whole needs to be better informed on what's in the UDI regulation, who and which items are affected and when the deadlines are. USDM Life Sciences will publish more details around this topic, including upcoming blogs about which products require UDI and how hospitals can use Master Data Management as a strategy to make sense of all their data. In the meantime, you are not in this alone.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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