Draft guidance released this morning by the Food and Drug Administration aims to clarify “expected content and forms” of unique device identifiers (UDIs) for medical devices.
The guidance specifies, for instance, that automatic identification and data capture technology (AIDC)--any technology that conveys a UDI into a form that can be entered into a patient’s electronic record or another computer system--should be in a bar code scanner-friendly format. FDA also notes that the AIDC form of the UDI can be split into multiple segments for space purposes. That can include two bar codes representing the device identifier and the product identifier, respectively.
The FDA also says labelers can use more than one kind of tool, such as a linear bar code and a data matrix code, to help those using different UDI capture methods.
The agency notes that “data delimiters," defined characters used to identify “specific data elements within an encoded data string,” should be included for the device and product identifiers. Data delimiters, according to FDA, help UDIs to be parsed into electronic systems after being scanned.
The FDA will move forward on UDIs this fall, requiring that Class II medical devices comply with regulations by Sept. 24. Class I and non-classified devices also will be required to meet the regulations, but not until 2018.
Earlier this month, Centers for Medicare & Medicaid Services Acting Administrator Andy Slavitt and FDA Commissioner Robert Califf, in a letter to Gary Beatty, chairman of the Accredited Standards Committee X12, said they hope the committee can include new standards for the next version of the Medicare claims form, set to be released Dec. 1. Slavitt and Califf said UDIs on claims forms will be beneficial for providers and payers in helping them “calculate and compare total costs and outcomes based on the device model used,” as well as aiding in the collection of patient data on devices and for innovation of the tools.
To learn more:
- here’s the draft guidance (.pdf)