The success of the FDA’s Unique Device Identification initiative relies heavily on high-quality data being submitted to the FDA’s Global UDI Database. Since medical device companies are ultimately responsible to the FDA for the accuracy of the submitted data, it is worthwhile to take a closer look at some common errors that can creep undetected into GUDID data records.
1) D-U-N-S® Number Issues: The D-U-N-S Number of the device labeler organization is one of the 55 required fields of data submitted to the FDA for each device record. This D-U-N-S should be associated with the company name and address printed on the device label itself. This should not be confused with the D-U-N-S of the labeler organization’s headquarters or parent organization, which is attached to the GUDID account. You should also make sure the D-U-N-S you enter contains nine (and only nine) digits and that those digits are correctly entered.
2) Primary DI Errors: You may already know that each UDI includes two parts, a Device Identifier (DI) and a Production Identifier (PI). The DI is submitted to the GUDID and can be up to 23 characters long. It is important to take special care in ensuring that these long strings of characters are entered correctly. Note that each approved DI Issuing Agency (GS1, HIBCC, and ICCBBA) have different data format and check digit rules, and that submitted data is not exactly the same as the Human Readable or Bar Code values printed on the product label.
3) Package DI Entry Errors: There may be several layers involved in the packaging of an individual medical device with different DIs assigned to each package level. For instance, a syringe as the base product would receive a Primary DI, while a box of 100 syringes would receive a secondary Package DI, as would a case containing four boxes and a carton containing six cases. It is important to ensure that the Primary and Package DIs are entered correctly in their respective fields and that Package DIs are not erroneously associated with an incorrect Primary DI record.
4) Size Entry Errors: Size information should be captured in the Clinically Relevant Size section rather than the Device Brand Name or Device Description fields. Use the Size List of Values where possible, in place of the Size Text field.
5) Version/Model Entry Errors: Simply enter the Device Version or Model value in these fields and omit the word “Version” or “Model.”
Of course, despite your best efforts, errors may occasionally go undetected in a device record and be submitted to the GUDID. If this happens, you will need to take proper steps to correct or retire and replace the record as soon as possible.
Reed Tech UDI expert Gary Saner will be speaking on the related topic of “Evaluating the GUDID – Data Quality and Troubleshooting Tips to Meet Compliance” at the upcoming Medical Device Global Labeling Strategies conference in St. Paul, MN, on August 12. Whether or not you are able to attend the conference, we welcome you to contact Reed Tech with any questions on this topic or other UDI issues.