On September 24, 2013, the Food and Drug Administration (FDA) issued its Unique Device Identification (UDI) System Final Rule, which establishes a system for adequately identifying medical devices through distribution and use, with a goal of substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. (See HIMSS Fact Sheet here.) As a result of this final rule, most medical devices distributed in the United States will be required to carry a unique device identifier (UDI). The UDI will be an unique numeric or alphanumeric code consisting of two parts:
- A device identifier (DI), which is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
- A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device.
In an article this week in Inside Health Policy, FDA noted that “UDI has been part of recent conversations at the Office of the National Coordinator (ONC) to include the identifiers in electronic health records under Stage 3 meaningful use. Further, at the beginning of the fiscal year, FDA was slated to send an employee on detail to ONC.”
It goes on to say that “preliminary conversations at ONC have resulted in a menu objective recommendation. If finalized, eligible hospitals and providers would have the option, among others, to record UDIs 80 percent of the time when patients have a device implanted. All EHRs also would be required to have the ability to capture UDIs. An ONC workgroup was expected to present these recommendations to a policy committee in early November, according to meeting documents prior to the government shutdown. An ONC spokesman declined to comment on when rulemaking would begin for Stage 3.”