FDA States Medical Devices in the US Must Carry a Unique Device Identifier (UDI)
Healthcare providers should welcome the recently proposed ruling by the Food and Drug Administration (FDA), which states that medical devices distributed in the United States will be required to carry a Unique Device Identifier (UDI) as part of labeling and packaging.
Currently there is no single global regulation for uniquely identifying medical devices in the supply chain. This means recalling devices is less efficient and more complex than it could and should be, negatively impacting patient safety and confidence. Consequences also can lead to poor reporting and auditability of such adverse events.
The standardization of a common UDI will increase visibility and improve the quality of information in medical device adverse event reports, improve traceability and security within the supply chain and reduce the potential of medical error through consistent, unambiguous and harmonized data. Furthermore, a common UDI will facilitate the storage, exchange and integration of data and systems between healthcare suppliers and providers.
At the point at which this proposed ruling becomes legislated, medical device companies and healthcare providers will require label design software that complies with UDI standards as well as internationally recognized bar coding standards (most likely GS1). With a change in FDA regulations now a question of ‘when and how’ rather than ‘if’, medical device organizations would do well to take advantage of the solutions available on the market that already address both these standards and start reaping the benefits of improved safety, security and efficiency.
Warren Ward-Stacey is the Sales Director of PRISYM ID, responsible for leading and driving results from the global sales team. He has a detailed knowledge of the auto-ID industry with particular emphasis on label production techniques. Warren is passionate in identifying and securing new business opportunities, whilst building business within our existing global client base to create year on year revenue growth. His belief in delivering market leading products to gain customer satisfaction is infectious and result’s in PRISYM ID having an enviable blue-chip customer base which is rapidly growing.