Design and implementation of the new Italian healthcare digital interoperable registry for implantable medical devices

Nowadays, the role played by registries in monitoring and improving healthcare, including the quality of medical devices, is widely recognized. A well-designed digital healthcare registry, in particular regarding data collection procedures and tools, can effectively support goals such as monitoring a (large) population subject to a specific condition, describing the natural history of diseases, supporting observational study methods, as well as evaluating the clinical effectiveness or cost effectiveness of healthcare products and services. This article describes the architecture of a new platform implementing a digital interoperable healthcare registry, the Italian Implantable Prostheses Registry (RIPI). One of the main goals of RIPI is to provide reliable and high-quality data for monitoring surgery outcomes, performing survival analysis, assessing the safety of devices and procedures, and supporting the traceability of patients. The article focuses on the key aspects and choices that guided the design and implementation processes of the new platform. Most of the design choices came from specific requirements to fulfill, in particular concerning data quality, access policy, interoperability, extensibility and modularity. Overall, the article discusses the main challenges and the adopted solutions, proposing a design perspective and describing an experience of interest for computer scientists, engineers and practitioners, in particular in the area of healthcare information systems

Il Registro Italiano delle Protesi Impiantabili: una nuova realtà per la sicurezza del paziente

The Italian Implantable Prostheses Registry: a new framework for patient safety Introduction The Italian Implantable Prostheses Registry (RIPI) was designed to monitor implants’ safety and performance, assessing outcomes of the surgical procedures and ensuring patients and implant traceability. This paper aims to present the RIPI project and its dimension in terms of procedures to be monitored. Materials and methods The RIPI’s architecture is modular and consists of a main body coordinating different registries for specific implantable devices. Data collection will use hospital discharges data integrated by an additional Minimum Data Set, specific for each class of implanted devices and defined by dedicated technical committees. The number of procedures expected to be monitored by RIPI was computed and the costs associated to the related hospital admissions were estimated. Results Currently, RIPI is designed to consider the implants of the following devices: joint prostheses, spinal devices, implantable cardioverter-defibrillators and pacemakers, and heart valves. In 2019, nearly 400.000 such procedures were performed in Italy. Their cost represented more than 3% of the national public healthcare expenditure. Data collection has already started for joint prostheses where the "Data quality first" approach is applied at all stages. The architecture of the future RIPI data collection platform might support collaboration with other international registries. Conclusions In the last two decades, the procedures considered by RIPI have doubled. In the future, survival analysis produced by RIPI can support the Ministry of Health in supervising medical devices and medical device manufacturers in monitoring the quality of their products, as required by EU Regulation 2017/745, thus improving the quality of patient care and reducing healthcare expenditure