FDA recently finalized guidance on direct marking a medical device with unique device identification (UDI), providing orthopaedic manufacturers with an unsurprising position on marking methods and identical use of UDI vs. device label.
The devices that require direct marking are those intended to be used more than once, or to be reprocessed before each use. Class III devices were required to carry a direct mark as of September 2016. Class II devices are set for a September 2018 deadline and Class I devices September 2020.
Regarding methods, FDA (as expected) did not identify specific methods to directly mark a device. According to the agency, “it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.” Furthermore, technology may lead to advancements in the years to come.
As outlined in the final guidance, possible methods to directly mark a device include:
- Attaching a permanent plaque to durable equipment
- Affixing a permanent tag, such as radio frequency identification, to the device
- In some cases, according to FDA, “a labeler will attach to the device hardware exterior a sticker or some other item that displays information and is designed to last the expected service life of the device. If this item bears the UDI in accordance with 21 CFR 801.45(b) and (c), you have fulfilled the requirements of 21 CFR 801.45.”
Labelers are also expected, according to final guidance, to conduct tests and analysis to document the impact that direct marking may have on the safety and effectiveness of a device.
In terms of format, UDI direct marking must include both the device identifier (DI) and production identifier (PI) portions of the UDI for Class III and Class II devices and the DI for Class I. Read more about the specifics of creating a UDI.
However, the final guidance states that FDA will not enforce the requirement that the PI (e.g., the lot number) is included if it’s unknown at the time that the device is directly marked. According to the Agency, “the labeler may choose to directly mark the device with a UDI identical to the UDI that appears on the label of the device, or with a different UDI to distinguish the unpackaged device from any device packaging containing the device.”
Essentially, orthopaedic manufacturers would need to direct mark the DI and provide a cross reference tool at point of implantation to ensure that the entire UDI (DI+PI) is recorded. This guidance was also based on previously-published comments between FDA and the AdvaMed Orthopedic Working Group.
While the full final guidance affirms a few more knowns, unique device identification remains a hurdle for many orthopaedic companies based on our conversations. The best way to handle direct marking remains an outstanding issue. Orthopaedic companies are also confronted with international UDI compliance, and concerns about how hospital customers want to capture the data. These are topics we plan to explore further in the March issue of BONEZONE and at OMTEC 2018. Until then, the final guidance for Unique Device Identification: Direct Marking of Devices can be read in full.