What are UDI Labels?
New UDI compliance dates are quickly approaching, so make sure you’re prepared with UDI solutions from Imprint.
UDI stands for Unique Device Identifier. In 2013, the FDA released its final ruling on UDI compliance. UDI compliance requires most medical devices in the United States to carry a unique device identifier. This also applies to certain combination products that contain compliance-required devices, as well as devices licensed under the Public Health Services (PHS) Act. Imprint Enterprises has the knowledge and experience to help you navigate through the complicated maze of regulations, printing and materials requirements, label design and layout, label printing, and hardware and software requirements associated with UDI compliance.
What are the UDI compliance requirements?
Imprint Enterprises has partnered with compliance hardware and software companies like Zebra Technologies to provide HL7 software, printers, supplies and everything necessary to bring your organization into UDI compliance. To become UDI compliant, you must first assign unique identifiers to devices’ labels and packaging. Any devices that are intended to be used more than once or be reprocessed before each use must be directly marked with a UDI. All UDI labels must contain the a standardized date in the correct format, YYYY-MM-DD. UDI regulations mandate that data for these devices must be submitted to GUDID, or Global Unique Identifier Database. There are two ways to upload your information to the GUDID:
- The FDA provides a browser-based interface for manual entry and editing of small numbers of devices. This option is only suitable for companies with very few products, as all data entry is manual.
- The FDA has published a specification that enables companies to electronically submit device information one record at a time as an HL7 Structured Product Labeling (SPL) xml file. This specification helps manage the upload and editing of larger numbers of items.
Benefits of UDI
UDI labels enable more accurate reporting, reviewing and analyzing of adverse event reports to enable quick identification and correction of problem devices. These regulations enable clinicians to quickly obtain important information on devices, reducing medical errors. It also provides a standard way to document device use in health information technology (HIT) systems, which increases effectiveness of medical device recalls. UDI compliance regulations enable a global, secure supply chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
How Can Imprint Help?
Imprint can help you make informed decisions on how to handle converting to UDI standards. Every product will present a unique challenge. Some products will need packaging labels, some will need direct device labels, and some will need both, but different materials will be needed for packaging and direct device labels. Imprint can help you decide on what’s best. Does your device require sterilization? Not all labels can withstand the process, so we can guide you to a label that will withstand sterilization and healthcare cleaning agents. If you’re using an applicator to apply the label, you’ll need specific label and liner combinations. Different branding requirements may also mandate pre-printed logos, colors, small text, or symbols. Imprint has the expertise to answer all of your UDI questions, and we have all the labeling capabilities to meet your needs and remain UDI compliant.