[The Italian ArthroPlasty Registry: a model to export?]

Abstract

Medical devices (MD) registries are essentials to evaluate outcomes. They represent a key tool to support market surveillance and vigilance, being critical to identify and characterize the implants, assess their performance and trace patients in case of recall. Therefore, the recent "Proposal for a Regulation of the European Parliament and of the Council on medical devices" asked both the Commission and the Member States to take all appropriate measures to encourage the establishment of registers for specific types of devices, setting common principles to collect comparable information. In Italy more than 170.000 joint replacements were performed in 2013 in over 750 hospitals. Experiences at international level and in some Italian regions show that data from registries are crucial to define the best approach to joint replacement surgery. Results from registries can lead to changes in clinical practice, adopting the best available evidence and avoiding choices associated with poorer outcomes. The Italian Arthroplasty Registry project (RIAP) started in 2006 funded by the DG of Medical Devices and Pharmaceutical Service of the Ministry of Health. Data collection uses Hospital Discharge Records integrated by additional information essential to describe the procedure and identify the implants. As soon as the new European Regulation is approved, a Unique Device Identifier will be assigned to every device. Lacking this information, device identification is currently possible by browsing the RIAP MD Library that includes about 55,000 records and is constantly updated by 60 Manufacturers. The model designed within the RIAP project is simple and might be applied for every implanted device when the additional minimum dataset is defined.