Tracking Unique Device Identifiers (UDIs) of Mini Fragment Implants with a Novel Optical Imaging System

Abstract

Background Small and mini fragment implantable medical devices (0.5 – 4.4mm) such as plates and screws that are placed into surgical trays pose a challenge to unique device identification (UDI) and tracking because they are difficult to directly mark, and often separated from labeling prior to reaching the point of care. Our objective was to demonstrate a novel optical system’s ability to track the unique identities of these small implants. Methods We performed a series of simulated craniotomy surgeries involving implants as small as 1.5mm in size, representing 13 different products from two manufacturers, to test whether a commercially available optical system (QuanTEK, Covisus, Inc.) could accurately track all implants through these simulations. The system was used to capture the unique surface texture of 236 implants at a micrometer scale and convert this to a unique “fingerprint” (vTag) for each item. Implants were placed in surgical trays, and these trays were subjected to a series of 16 simulated surgeries. After each surgery, trays were scanned and identified to determine which had been used, moved, or added. Results Post-surgical scans accurately identified the location and unique identity of 100% of implants (953 out of 953 times; 853 screws, 62 plates, 38 burr hole covers scanned; 95% confidence interval = 99.6 to 100%). Conclusions Results demonstrate that under simulated conditions, the system was able to register and verify the unique identities of mini fragment implants through surgical procedures with 100% accuracy. This technology could therefore be used to finally fulfill the goal of providing hospitals and supply chain management a solution to tracking the full UDI of all implantable medical devices used in the operating room, including the very smallest devices.