FDA launches program to ID health care devices
The U.S. Food and Drug Administration (FDA) formally announced its long-anticipated Unique Device Identification system, designed to provide a consistent way to identify medical devices.
The UDI program could help curb illegal sales of contacts without a prescription.
Under the new system, all FDA-regulated health care devices—contact lenses, ophthalmic cameras and ophthalmic lasers, for example—will be required to have a unique device identifier (UDI) assigned by the device manufacturer. This identifier will include production-specific information such as the product's lot or batch number, manufacturing date, and expiration date.
The identifier will be included in a bar code or similar marking on the product's label or the product itself. It also will be listed in a publicly searchable FDA database called the Global Unique Device Identification Database (GUDID).
How the UDI will help
The FDA believes the UDI system will:
- Help prevent medical errors
- Make the recall process more efficient and effective
- Improve the accuracy of adverse event reports
- Provide a foundation for secure distribution chains and help address counterfeiting and diversion
- Offer a clear way to document device use in electronic health records.
The AOA Advocacy Group believes the UDI program represents a crucial step toward curbing illegal sales of contacts without a prescription.
When the UDI takes effect
The FDA formally published the UDI rule Sept. 24. The program will officially begin 90 days later, with full implementation by 2020.
Under the planned implementation schedule, here is how eye care devices will be affected:
- Class III ophthalmic devices, such as extended-wear contact lenses, will require UDIs by Sept. 24, 2014. However, manufacturers can request one-year extensions.
- Class II ophthalmic devices such as daily wear contact lenses and some diagnostic or therapeutic instrumentation (ophthalmic cameras, ophthalmic lasers) will require UDIs by Sept. 24, 2015.
- Class I ophthalmic devices such as prescription spectacle lenses, eyeglass frames, most low-vision devices and many ophthalmic instruments will require UDIs by Sept. 24, 2016. However, many such devices could be granted exemptions under the program rules.
The AOA warns consumers about the risks of purchasing and wearing contact lenses without a valid prescription and proper medical evaluation from a doctor of optometry. The AOA also encourages optometrists to report any cases of harm from illegally purchased lenses.