The Food and Drug Administration (FDA) has required medical device manufacturers to print unique device identifier (UDI) information on device packaging for years now. Unfortunately, whereas manufacturers experience inherent challenges, UDIs also present problems for end users. However, new guidance from the FDA offers a way to identify UDIs on package labeling more clearly.
What is a UDI?
A UDI is simply a way to trace a device’s origin. It’s similar to the Universal Product Code (UPC) found on consumer products at a retailer.
A UDI is a unique numeric or alphanumeric code placed on a device by its manufacturer or labeler. It includes automatic identification and data capture (AIDC) technology, such as barcodes or radio frequency identification. There are two parts to a UDI:
- A device identifier specific to the device model or version and the manufacturer/labeler.
- A production identifier with the lot or batch number, serial number and/or expiration date.
Benefits of UDIs
UDIs offer traceability for medical devices. They are crucial for implantable devices such as breast implants and stents that cannot be accessed once inside patients’ bodies. Before a surgical procedure, a provider scans the UDI and the information is stored in the patient’s electronic health record. That way, health care professionals can trace its origins if a problem with the device arises.
Additionally, UDIs allow the manufacturer to locate its devices if there’s a complaint about a particular device. Knowing this information may help avoid general recalls if the problem can be traced to a single batch or lot, saving hundreds of thousands of dollars.
UDIs are also necessary on the user end. They help with inventory control and streamline charge capture and billing for health care organizations.
Problems for users
It’s easy to see why UDIs are important in medical device manufacturing and labeling. But healthcare practitioners have historically found it challenging to find UDI information quickly. In healthcare, time is often of the essence, so locating the UDI at a glance is essential.
The problem is that some devices have multiple barcodes. As a result, it’s difficult for healthcare professionals to ascertain which barcode is the UDI. The Association for Health Care Resource & Materials Management Learning UDI Community working group launched a study to find a remedy. The group surveyed health care providers in 2018 to better understand challenges associated with point-of-care barcode scanning.
Survey respondents were asked whether printing “UDI” next to the barcode would be helpful. More than 85 percent said yes.
A simple solution
The next step was developing an appropriate graphical symbol. In 2019, an International Organization for Standardization (ISO) committee convened to develop and validate a symbol. The validation process solicited feedback from point-of-care practitioners across several verticals within the medical device industry. The result looks like this:
In July 2021, the ISO published the symbol and guidance for using it. The symbol is meant to improve usability when a medical device label must bear multiple barcodes, but its usage remains optional.
FDA guidance on UDIs
The FDA has also weighed in. In the final guidance document, Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI), the FDA says if the AIDC technology with the UDI is not immediately evident, the label must specify the location of the UDI. In other words, the FDA says manufacturers should include the UDI symbol on labels that have more than one barcode or scannable graphic.
While using the UDI symbol remains optional, practitioner advocacy groups encourage manufacturers to use it on labels with more than one barcode. Ultimately, using the UDI symbol ensures health care providers scan the correct barcode and improves user efficiency.
Cenmed understands the importance of UDIs in medical device manufacturing and the healthcare supply chain. When you trust us to create custom medical devices or custom kits/packaging, rest assured that we will follow all regulations closely so your company complies with federal guidelines. Supporting your mission in Healthcare, Research and Science™. Request a quote today.
Sources:
https://www.youtube.com/watch?v=HeaURP2vQMA
https://www.masimo.com/company/global-services/udi-labeling/
https://www.iso.org/standard/77326.html
https://www.ahrmm.org/system/files/media/file/2019/11/Barcode-at-POC-work-group-report-102019.pdf
