Medical Devices in the Region of Tuscany, Italy: Definitions of Innovative Devices and Potentially Innovative Devices...

In the region of Tuscany in Italy, since 2019, medical devices belonging to risk classes 2b, 3, or active implantable have been managed by a multidisciplinary health-technology assessment body initially composed of eight members and extended to 23 members in 2022, thus creating the Centro Operativo. In 2021, an original algorithm for the identification of innovative devices based on objective criteria was developed and formally recognized over the following years. However, since these criteria identified only a small number of innovative devices, we tried to develop another algorithm aimed at identifying a new classification (called "potentially innovative device"), which was intended to be intermediate between full innovation and no innovation. Since preliminary analyses showed that objective criteria were not able to identify this intermediate classification, we relied on the expert opinion of the Centro Operativo for this purpose. In this article, we analyzed all the devices requested by Centro Operativo in the first half of 2024 for a total of 17 devices. Only one met the criteria of innovation and, therefore, was purchased; the other 11 were evaluated as adequate to be purchased based on clinical and/or economic reasons, whereas the remaining six did not. To create an operational relationship between these decisions and the definitions of innovativeness, the Centro Operativo explored a simple model wherein the 11 devices that failed to meet full innovativeness but were judged adequate to be purchased were classified as potentially innovative. In comparison, the remaining six devices were considered not innovative. On the one hand, we report the results of this preliminary experience; on the other hand, we plan to implement this form of management of high-technology devices into a regional regulation that will be applied for the next months in all hospitals of our region.