The Food and Drug Administration just released a set of new guidance documents to clarify the UDI process for medical device manufacture. Why?
Medical devices that are used repeatedly have to be assigned a UDI – a “unique device identifier” that helps identify and track which is which. It’s meant to reduce medical errors, and speed up the process in discovering device errors.
This is a relatively new concept, however – the UDI process has only been in effect since September 2013, and will be phased into general practice slowly. But given the disparate sizes, shapes and configurations of medical devices, it’s sometimes tricky to know what a UDI is supposed to look like, and where it’s meant to go.
The UDI has two parts – a device identifier that tells the specific model of the device, and a production identifier. This bit is variable, and can include the lot or batch number, the serial number, the expiration date, the manufacture date, and a distinct identification code that’s required for all human cell or tissue-based products.
All UDIs have to be cleared through the FDA. The new guidance is meant to simplify the process, and provides a Q&A portion. Here are some of the highlights:
- The timeline for UDI compliance varies depending on the class of device. Life-sustaining and life-supporting devices have to have UDI markings by September 24 this year. Class III devices are mandated to comply by September 24, 2016; Class II by 2018 and Class I and unclassified devices by 2020.
- Devices already in use have an additional three years to become UDI compliant; the above deadlines really only apply to new devices.
- FDA doesn’t mandate exactly how to mark the devices; however, it suggests that etching or attaching a permanent plaque to durable equipment as possible solutions.
