*Open-Source Tool for UDI Capture at the Point of Patient Care

Point-of-care capture of Unique Device Identifiers (UDI) for non-sterile medical devices presents a persistent and well-documented challenge in the clinical setting. Non-sterile implants - such as orthopedic screws, plates, and rods - are delivered from the manufacturer in labeled packaging but must be sterilized by the hospital prior to use. The sterilization process requires removal of the device from its packaging, which is typically the only carrier of the UDI label. Additionally, the size, geometry, and substrate composition of many implants make direct device marking technically impractical or infeasible under current standards. This gap results in significant loss of traceability at the moment of implantation, undermining the foundational goals of the UDI system: patient safety, post-market surveillance, and adverse event tracking. In 2018, the FDA Innovation Lab and CDRH's Office of Science and Engineering Laboratories (OSEL) initiated a Critical Path-funded project exploring image recognition as an approach to identify UDIs from device packaging prior to sterilization. This proposal is to build on that prior work towards a validated, open-source solution that can be disseminated for use by hospitals and healthcare providers, complementing existing commercial offerings.