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

Area of Science:

• Medical device regulation and post-market surveillance.
• Health informatics and data management.
• Orthopedic surgery outcomes research.

Background:

• Medical device (MD) registries are essential for evaluating outcomes, market surveillance, and patient traceability during recalls.
• European regulations emphasize the need for comparable data collection in device registers.
• Over 170,000 joint replacements were performed in Italy in 2013, highlighting the importance of registry data for surgical approaches.

Purpose of the Study:

• To highlight the critical role of medical device registries in assessing implant performance and informing clinical practice.
• To present the Italian Arthroplasty Registry (RIAP) as a model for establishing comprehensive device data collection.
• To discuss the integration of Hospital Discharge Records and additional data for implant identification.

Main Methods:

• Utilizing Hospital Discharge Records integrated with supplementary data for detailed procedure and implant information.
• Developing and maintaining the RIAP MD Library, containing approximately 55,000 records updated by 60 manufacturers.
• Leveraging existing data infrastructure to create a scalable registry model.

Main Results:

• The RIAP project, initiated in 2006, successfully collects and manages data on arthroplasty procedures.
• The RIAP MD Library facilitates device identification in the absence of a universal Unique Device Identifier.
• The established model is adaptable for other implanted devices with defined minimum datasets.

Conclusions:

• Medical device registries are crucial for evidence-based clinical practice and improved patient outcomes in joint replacement surgery.
• The RIAP project provides a functional model for device data collection that can be extended to various implanted devices.
• Standardized data collection through registries supports regulatory compliance and enhances post-market surveillance.