{"id":59042,"date":"2021-06-24T11:39:10","date_gmt":"2021-06-24T09:39:10","guid":{"rendered":"https:\/\/www.fedaiisf.it\/?p=59042"},"modified":"2021-06-24T11:39:10","modified_gmt":"2021-06-24T09:39:10","slug":"dispositivi-medici-rapporto-sulle-attivita-di-vigilanza-2019","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/dispositivi-medici-rapporto-sulle-attivita-di-vigilanza-2019\/","title":{"rendered":"Medical devices, supervisory activity report 2019"},"content":{"rendered":"<p>The <a href=\"https:\/\/www.salute.gov.it\/portale\/documentazione\/p6_2_2_1.jsp?lingua=italiano&amp;id=3082\" target=\"_blank\" rel=\"noopener\">Report on medical device surveillance activities<\/a>\u00a0contains an analysis of data for the year 2019 on <img loading=\"lazy\" decoding=\"async\" class=\"wp-image-51421 alignright\" src=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici.jpeg\" alt=\"\" width=\"492\" height=\"333\" srcset=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici.jpeg 596w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-300x203.jpeg 300w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-220x150.jpeg 220w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-364x245.jpeg 364w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-80x54.jpeg 80w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-130x87.jpeg 130w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-85x57.jpeg 85w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-266x179.jpeg 266w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-112x75.jpeg 112w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-179x120.jpeg 179w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2020\/06\/Dispositivi-medici-81x55.jpeg 81w\" sizes=\"auto, (max-width: 492px) 100vw, 492px\" \/><strong>accidents with medical devices<\/strong>, collected in the database of the surveillance system on reports from healthcare professionals and manufacturers.<\/p>\n<p>The Ministry carries out a constant monitoring activity on the accidents that occur with medical devices after their placing on the market, also thanks to the collaboration with all the stakeholders involved in the system, collecting and analyzing all the data that flow into the surveillance system.<\/p>\n<p><span style=\"font-size: 14pt;\"><strong>The 2019 Report<\/strong><\/span><\/p>\n<p>The Report presents numerous additional insights compared to the previous one and also includes an assessment of the accidents involving i\u00a0<strong>in vitro devices (IVDs)<\/strong>.<\/p>\n<p>The publication is divided into two sections:<\/p>\n<ul>\n<li>the first concerns the description of data on<strong> incidents that occurred in 2019<\/strong>, and pays particular attention to the categories of medical devices that have had a higher frequency of accidents<\/li>\n<li>the second provides <strong>insights <\/strong>on some issues of particular interest in the context of supervisory activities.<\/li>\n<\/ul>\n<p>The surveillance system of the Ministry of Health recorded, in 2019, <strong>6,421 accident reports<\/strong> with medical devices; 435 reports concern in vitro diagnostic medical devices (IVD).<\/p>\n<p>The analysis of the accident reports in reference to the Region in which the event occurred highlights a strong territorial lack of homogeneity, suggesting more or less marked phenomena of under-reporting.<\/p>\n<p>The second section includes an overview of insights on the subject of very broad supervision of breast implants, health equipment and related components and accessories, medical devices in the cardiovascular sector, the cardiovascular sector and the orthopedic sector, devices for administration, sampling and collection. An in-depth study is dedicated, among the supervisory activities, to the fight against counterfeiting.<\/p>\n<p>For further information consult:<\/p>\n<ul>\n<li>the Medical Devices &gt; page\u00a0<a href=\"https:\/\/www.salute.gov.it\/portale\/temi\/p2_6.jsp?lingua=italiano&amp;id=90&amp;area=dispositivi-medici&amp;menu=vigilanza\" target=\"_blank\" rel=\"noopener\">The surveillance system<\/a><\/li>\n<li><a href=\"https:\/\/www.salute.gov.it\/portale\/documentazione\/p6_2_2_1.jsp?lingua=italiano&amp;id=3082\" target=\"_blank\" rel=\"noopener\">Medical Device Supervisory Activity Report 2019<\/a><\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.salute.gov.it\/portale\/news\/p3_2_1_1_1.jsp?lingua=italiano&amp;menu=notizie&amp;p=dalministero&amp;id=5530\" target=\"_blank\" rel=\"noopener\">Ministry of Health \u2013 21 June 2021<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Il Rapporto sulle attivit\u00e0 di vigilanza sui dispositivi medici\u00a0contiene un&#8217;analisi dei dati relativi all&#8217;anno 2019 sugli incidenti con dispositivi medici, raccolti nella banca dati del sistema di vigilanza su segnalazione degli operatori sanitari e dei fabbricanti. Il Ministero svolge una costante attivit\u00e0 di monitoraggio sugli incidenti che avvengono con i dispositivi medici successivamente alla loro &hellip;<\/p>","protected":false},"author":4,"featured_media":29256,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-59042","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/59042","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=59042"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/59042\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/29256"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=59042"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=59042"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=59042"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}