{"id":2767,"date":"2020-02-17T12:21:44","date_gmt":"2020-02-17T11:21:44","guid":{"rendered":"https:\/\/ripi.iss.it\/ripi\/?page_id=2767"},"modified":"2023-11-28T12:08:05","modified_gmt":"2023-11-28T11:08:05","slug":"the-project","status":"publish","type":"page","link":"https:\/\/ripi.iss.it\/ripi\/en\/the-project\/","title":{"rendered":"The project"},"content":{"rendered":"<div class=\"hbps-responsive-video\"><iframe loading=\"lazy\" title=\"Il Registro italiano delle protesi impiantabili\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/oYvUEkI5eoM?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<p>A topic that emerges whenever problems occur on implantable medical devices, is the need for national registries, an essential tool to protect patients\u2019 health and safety.<\/p>\n<p>That is why a specific article (art.108) has been included in the European Regulation 2017\/745 on medical devices in which Member States are asked to take \u201cAll appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics\u201d.<\/p>\n<p>Similarly, in Italy, in 2012, with the decree-law 179, converted into Law 221, the legislator created the framework that currently supports the implementation of surveillance systems and registries of particular concern for public health, identified with the Prime Minister&#8217;s Decree on 03\/03\/2017. These surveillance systems and registries, whose filling by regions and healthcare professional has been made mandatory with Law 145 of 31\/12\/2018 (paragraph 558), are formally established once approved by the regulation sets by the Prime Minister&#8217;s Decree.<\/p>\n<p>Among these surveillance systems and registries, there are the Registry of implantable prostheses (<strong>The <\/strong><strong>Italian Implantable Prostheses Registry<\/strong><strong>, RIPI<\/strong>) and the <a href=\"\/ripi\/en\/related-projects\/rnpm\/\"><strong>National <\/strong><strong>Breast Implants Registry<\/strong> (RNPM)<\/a>, headed respectively by the <strong>Italian <\/strong><strong>National Institute of Health (Iss)<\/strong> and the Ministry of Health.<\/p>\n<p>An implantable devices registry is a systematic data collection of all the implantable device replacements procedures (joint replacements, spinal implants, cardiac devices, artificial heart valves) performed in a defined geographic area (a national registry collects data at a national level).<\/p>\n<p>The aims of the registry are, firstly, to facilitate recalling patients in case of implantable devices\u2019 failures and, secondly, to analyse collected data for statistics and survival analysis, to measure how long an implant lasts. These analyses are a very powerful tool for early detection of any problems which, otherwise, could compromise patient\u2019s health.<\/p>\n<p>RIPI will allow, as in other countries, to have an efficient tool for patients\u2019 health protection. In fact, with the data produced by the Registry it will be possible to support the Ministry of Health in its surveillance and supervision activities on medical devices. Furthermore, the results of the survival analysis will be a useful reference for manufacturers to monitor the quality of their products, allowing them to participate in the prostheses\u2019 international benchmarking, contributing to the early reporting of any adverse events.<\/p>\n<p>RIPI is organized as a cross coordination structure of individual registries of implantable devices divided by subject:<\/p>\n<p><strong><a href=\"\/\/riap.iss.it\/riap\/en\/\" target=\"_blank\" rel=\"noopener noreferrer\">RIAP \u2013\u00a0 Italian Arthroplasty Registry<\/a><\/strong><\/p>\n<p><strong><a href=\"\/ripi\/en\/the-project\/ridis-italian-spine-registry\/\">RIDIS \u2013 Italian Spine Registry<\/a><\/strong><\/p>\n<p><strong><a href=\"\/ripi\/en\/the-project\/ridep-italian-implantable-cardioverter-defibrillator-and-pacemaker-registry\/\">RIDEP \u2013 Italian Implantable Cardioverter-defibrillator and Pacemaker Registry<\/a><\/strong><\/p>\n<p><strong><a href=\"\/ripi\/en\/the-project\/rivac-italian-heart-valves-registry\/\">RIVAC \u2013 Italian Heart Valves Registry<\/a><\/strong><\/p>\n<p><a href=\"https:\/\/ripi.iss.it\/ripi\/en\/the-project\/ridiu-italian-implantable-hearing-device-registry\/\" target=\"_blank\" rel=\"noopener\"><strong>RIDIU &#8211; Italian Implantable Hearing Device Registry<\/strong><\/a><\/p>\n<p><a href=\"https:\/\/ripi.iss.it\/ripi\/en\/the-project\/ricraf-italian-craniofacial-implant-registry\/\" target=\"_blank\" rel=\"noopener\"><strong>RICRAF &#8211; Italian craniofacial implant registry<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A topic that emerges whenever problems occur on implantable medical devices, is the need for national registries, an essential tool to protect patients\u2019 health and &#8230; <\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2767","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>The project | RIPI<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/ripi.iss.it\/ripi\/en\/the-project\/\" \/>\r\n<meta property=\"og:locale\" content=\"it_IT\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"The project | RIPI\" \/>\r\n<meta property=\"og:description\" content=\"A topic that emerges whenever problems occur on implantable medical devices, is the need for national registries, an essential tool 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