Identification... Unique Device Identification.

The other night, while I was drinking a refreshing beverage (neither shaken, nor stirred) and completely engulfed in an iconic (British) action-espionage movie, I began thinking of fingerprints (thanks to the movie's protagonist using spiffy spy gear to trick the baddies!) and how they are unique to the individual who possesses them, and in theory sort of like snowflakes and kind of like Unique Device Identification (UDI).

The FDA’s proposed rule (77 FR 40736) on November 19^th, 2012 applies to devices that are implantable, life-saving/life-supporting, or life-sustaining. The majority of US distributed medical device products will possess a UDI.(1-2)

Well, what exactly is a UDI? Specifically, a UDI is a unique alphanumeric or numeric code that includes a device identifier that is specific to the product model and production identifier, such as a lot number, which will contain specific current production information for the product model. These UDIs will be organized in a database, created by the FDA, in order to better keep track of all the UDIs. Don’t be alarmed - your personal information will not be included in the database and will not include personal identifiers pertaining to the products’ users. The database will include identifying information for each UDI. A standardized set of basic identifying information will be included in the UDI; the majority of which will be publically available on the database.

Utilization of a more robust data set, as a result from medical device product UDIs, could increase response time in identifying problems with medical devices, increase accuracy of recalls, and increase patient safety. The data will also be used to enhance the quality of information that is included in adverse event reports. The potential results of the UDI proposed rule appear to be great. However, I believe two important questions must be asked… “How realistic/applicable will the results of the UDI proposed rule be in such settings?” and “How feasible is implementation?” At this moment, I cannot answer these questions. However, I feel that mainly time and effort can determine if this proposed rule will live up to its expectations.

Questions? Comments? I want to know!

-RSpelich ^_^

1.) Federal Register. Unique Device Identification System. Available at: https://www.federalregister.gov/articles/2012/07/10/2012-16621/unique-device-identification-system. Accessed on 15 Jan. 2013.

2.) Federal Register. Unique Device Identification System - Amendment. Available at: https://www.federalregister.gov/articles/2012/11/19/2012-28015/unique-device-identification-system. Accessed on 15 Jan. 2013.