Developing a Classification of Spinal Medical Devices: Has the Time Come? Review of the Literature and a Proposal for Spine Registries.

Registries require standardized component libraries based on predefined taxonomies to ensure detailed and structured descriptions of implanted devices, enabling effective monitoring of implant safety. Considering the growing use of spinal implantable devices, we aimed to propose a comprehensive classification framework for spinal devices, to be integrated into the Italian Spine registry framework. The taxonomy was created using a detailed process that included reviewing existing literature, analyzing technical documents, selecting important device characteristics, obtaining feedback from manufacturers, and converting the information into a format suitable for IT systems. Our findings showed the lack of a globally accepted classification system. We identified four primary categories, further refined into subcategories, complemented by attributes for device identification, traceability, and characterization, then structured them using XSD schemas. Our proposal represents the first known attempt to implement a taxonomy for spinal implants, with the potential to serve as an international reference. A structured classification system would enhance registry interoperability, facilitate cross-registry comparability, and improve the early detection of adverse events, thereby strengthening patient safety and clinical outcomes. Furthermore, the adoption of a unified classification framework would improve surgeons' clinical practice and support policymakers in developing early prevention strategies, ultimately improving patient care.