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Comparing UDI and DSCSA coding

Although there are differences between the medical device Unique Device Identification (UDI) regulation and the Pharmaceutical Drug Supply Chain Security Act (DSCSA), Videojet Technologies’ Tim Kearns finds many common aspects across both.

In general, Kearns says, both the UDI and DSCSA provide structure to enhance and secure the supply chain for their respective industries, but ultimately address improving patient safety.

“There are differences in the data transfer and management between the two which will determine complexity of software and IT systems,” Kearns explains.“Yet, looking at the code itself, we can highlight the important aspects of each, shared or distinct.

“Mutually, both UDI and DSCA will require human-readable, plain text and Automatic Identification and Data Capture (AIDC). The AIDC will be in the format of high-resolution barcodes, albeit perhaps in different structures. Whether for UDI or DSCSA, the key is clear: the codes must be robust and sustainable through the supply chain for accurate product identification,” says Kearns. (SEE RELATED STORY HERE.)

What’s required?

• Medical Device UDI: Unique Device Identifier in plain text and AIDC on the package—Identifier is typically unique to lot/batch only.

• Pharmaceutical DSCSA: Unique Product Identifier in plain text and AIDC on the package—Identifier is unique to each individual saleable product (serial number).

What’s in the code?

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