UNIQUE DEVICE IDENTIFIER PROPOSAL TIED TO HOSPITAL IT SYSTEMS, EXPERTS SAY
To be effective, the unique device identifier (UDI) system proposed by the FDA must work alongside upgrades in hospital IT systems that include the integration of electronic health records (EHRs), experts said at a recent meeting.
Many hospitals are in the process of integrating EHRs, and "it's only a matter of time before devices will need to pass through that system," said Joe Pleasant of the group purchasing and hospital consulting firm Premier. Devicemakers should address the situation now, he said.
A UDI is a serial number, lot number or other number on a device. Some firms have been skittish about the idea of having UDI forced on them, especially after an Eastern Research Group (ERG) report in March said that, since UDI systems "might allow much greater opportunity for price and performance comparability," the lack of such comparability probably benefits manufacturers.
In today's IT-dominated world, UDIs should be electronically readable. The FDA sees in UDIs the potential for:
Better identification of devices when adverse events occur;
More rapid, accurate recalls; and
Improved postmarket surveillance capability.
But to achieve those benefits, UDIs would have to be coupled with enhanced health IT in hospitals, such as device identification and locator systems that can provide specific model information and be used to compare device effectiveness, said ERG's John Eyraud.