Messori Andrea, Trippoli Sabrina
Health Technology Assessment (HTA) Unit, Regione Toscana, Florence, ITA.
Cureus. 2024 Dec 16;16(12):e75839. doi: 10.7759/cureus.75839. eCollection 2024 Dec.
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.
在意大利托斯卡纳地区，自2019年以来，属于2b、3类风险或有源植入式的医疗器械由一个多学科健康技术评估机构管理，该机构最初由8名成员组成，2022年扩大到23名成员，从而创建了运营中心。2021年，开发了一种基于客观标准识别创新设备的原创算法，并在随后几年得到正式认可。然而，由于这些标准仅识别出少数创新设备，我们试图开发另一种算法，旨在识别一种新的分类（称为“潜在创新设备”），该分类旨在介于完全创新和无创新之间。由于初步分析表明客观标准无法识别这种中间分类，我们为此依赖运营中心的专家意见。在本文中，我们分析了运营中心在2024年上半年要求评估的所有设备，共计17台。只有一台符合创新标准，因此被采购；其他11台基于临床和/或经济原因被评估为适合采购，而其余6台则不适合。为了在这些决策与创新定义之间建立操作关系，运营中心探索了一个简单模型，其中11台未达到完全创新性但被判定适合采购的设备被归类为潜在创新设备。相比之下，其余6台设备被认为不具有创新性。一方面，我们报告了这一初步经验的结果；另一方面，我们计划将这种高科技设备管理形式纳入一项地区法规，该法规将在未来几个月应用于我们地区的所有医院。
