A far-reaching Regulation for the Italian National Registry of Implantable Prostheses: a possible model for other health registries.

Abstract

Medical device registries are major tools for public health, able to provide early warning systems for increasing the patient safety. We are now at the forefront of a final legal and procedural step to design the Regulation of the Italian Implantable Prostheses Registry (RIPI) and to make data collection mandatory. This can ensure prostheses traceability, recall of patients and fuel biomedical and epidemiological research. Data completeness will be greatly improved when the Regulation is issued. At that time, rules for accessing data and subjects/entities allowed to access the Registry will be clearly defined. Therefore, the Regulation content is crucial, with no chance to fail in its design. The thorough expertise gained at the Italian National Institute of Health (Istituto Superiore di Sanità) by the Italian Arthroplasty Registry in terms of scientific, technical and privacy management may represent a prototypical model for other registries. Our aim is to identify a few key issues to shape a far-reaching Regulation that might permit the flexible and dynamic functioning of RIPI providing suggestions for other registries at national and international level.