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.