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Any unique device identification system adopted by FDA will likely include a database to be integrated with DailyMed (above).
FDA is analyzing feedback on its proposed requirement for unique device identification and is trying to figure out how to put a system in place that does not lead to unintended consequences, said an agency patient safety official.
A unique device identification system would help with reporting adverse events and tracking recalls, said Jay Crowley, FDA's senior advisor for patient safety. He spoke at March's AAMI/FDA International Conference on Medical Device Standards and Regulation.
The identifier system would consist of a device ID, which gives the manufacturer, make and model, and the production ID, which gives the lot or serial number and production date. Many devices don't currently have production IDs, however. It is also not clear how reprocessed single-use devices whose regulatory clearances are held by the reprocessor and not the manufacturer would be handled, Crowley said.
The unique device ID would be placed at the unit of use and ideally have open-source technology so as to be readable by as many systems as possible. “We would like to stay out of the technology debate and remain neutral on that,” said Crowley. “But hospitals may want some sort of predictable technology to be used.”
The database would include the identification of the device, information for safe use, and a dynamic record of use over the device's lifetime. It would likely be integrated with DailyMed, a database that keeps the most current versions of pharmaceutical labeling, Crowley said.
Jeffrey Secunda, AdvaMed's associate vice president for technology and regulatory affairs, said it may make sense to require unique identification for certain classes of devices, but not all of them.
“We need to develop consensus standards for different modes and applications of unique device identification to achieve patient safety improvements,” he said. “Solutions must include a viable plan for adoption by device users.”