September 23, 2024 – Covisus: 3.4 Tagless UDI tracking of non-sterile implants with no changes to implants, trays or packaging.
As noted in the US FDA website, “the FDA established the unique device identification (UDI) system to adequately identify medical devices sold in the Untied States from manufacturing through distribution to patient use”. This directive requires device labelers, who are typically the device manufacturers, to include UDI information on device labels and packages. All classes of medical devices shipped in sterile packages are in full compliance with these rulings. Non-sterile implantable devices (class II and III), such as orthopedic plates and screws, are shipped in packaging that include UDI information. However, at a medical facility, the implants are removed from their packaging, placed in surgical trays and sterilized prior to surgery. During this process, the UDI information is lost and is not traced to a patient’s medical records. While many larger implantable plates are directly marked with their UDI information (Direct Part Marking -DPM), close to 60 million implantable screws and countless plates used annually in surgeries across the country are not marked as they are too small. This results in a major non-compliance to FDAs requirement. As a result, the agency is restricted in its ability to perform post-market surveillance and manage recalls of most non-sterile implants. In addition to risking patient lives, health facilities are often stuck with large inventories of non-sterile implantable devices with unknown provenance that require complex and expensive dispositioning.
We report on a commercially available system developed for the Department of Defense to meet their Intrinsic Unique Device Identifier (IUID) requirements (DFARS 252.211-7003) and its applicability to meet FDA’s Unique Device Identifier (UDI) requirements. This system uses an imaging assembly mounted onto an automated robotic platform. At a rate of approximately 1 second per part, it rapidly captures the unique surface texture of an implantable device and from it creates an immutable unforgeable intrinsic “fingerprint” that acts as a system generated item specific token. No direct part marking, RFID or other labels are required. A proof-of-concept study with this device was performed at a hospital on multiple non-sterile neuro surgical kits from two different manufacturers. At the hospital Central Supply, all screws and plates from the kits were scanned with the imaging system that generated an item specific digital token to which the devices UDI information was linked. This information was stored in a database that can be linked with a hospital’s ERP system in the future. Trays were then sterilized and either sent to surgery or to a hospital representative who simulated surgical conditions. Following use, the washed trays were then returned to Central Supply and verified with the imaging system. The reconciliation reports generated by the imaging system were cross checked with either the surgical report or simulated study report. Our study showed that the UDI information associated with all screws and plates were retained through the entire process with minimal disruption to the workflow at Central Supply and no work/overhead on surgical staff. In addition to being in compliance with FDA UDI requirements, we found multiple scenarios where the imaging system was able to flag non-conforming implants that could improve overall quality during kit preparation. This “value beyond compliance” is expected to enhance patient safety.