Update on UDI Implementation

The FDA sought detailed feedback from medical device manufactures and hospitals on a unique device identification database (UDID) prototype recently. A pilot study, conducted in August of 2009, was done to determine the feasibility of collecting and storing UDI data from the supplier to the product’s point of use at five hospitals. The study included data on 621 devices.

The results point to a bit of confusion over how to handle data. Overall, participants thought that the UDI database prototype performed well, but there were concerns about the amount of data suppliers would need to provide. They also had questions about locating the information once in the database.

Recommendations to the FDA from suppliers and users include implementing a more automated way to upload data to the database, the ability to change or edit a UDI code once it is entered into the database, and a finalized list of UDI attributes to make it easier for manufacturers to comply with the data requirements.

Manufacturers also want the FDA to clarify definitions to be used in the database and settle on the standards the definitions should meet. Most agree that either the GS1 or the Health Industry Business Communications Council standards should be used.

As a result of this pilot, the FDA has some clear feedback as to what suppliers and users need from the UDID and will begin drafting regulations to implement UDI.

You can read the full report on the study here