{"id":8006,"date":"2023-07-25T16:36:53","date_gmt":"2023-07-25T14:36:53","guid":{"rendered":"https:\/\/alara-group.fr\/?p=8006"},"modified":"2023-08-02T10:34:37","modified_gmt":"2023-08-02T08:34:37","slug":"veille-die-vorschriften-fuer-die-qualitaetskontrolle-von-mammographieeinrichtungen-aendern-sich","status":"publish","type":"post","link":"https:\/\/alara-group.fr\/de\/veille-die-vorschriften-fuer-die-qualitaetskontrolle-von-mammographieeinrichtungen-aendern-sich\/","title":{"rendered":"[VEILLE] Die Vorschriften f\u00fcr die Qualit\u00e4tskontrolle von Mammographieeinrichtungen \u00e4ndern sich"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8006\" class=\"elementor elementor-8006 elementor-8005\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c62b14a elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"c62b14a\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3c90580\" data-id=\"3c90580\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3b8a972 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b8a972\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f7aa4fb\" data-id=\"f7aa4fb\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-69fc6f4 elementor-align-left elementor-widget elementor-widget-post-info\" data-id=\"69fc6f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-5eb95cd elementor-inline-item\" itemprop=\"about\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-terms\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-post-info__terms-list\">\n\t\t\t\t<a href=\"https:\/\/alara-group.fr\/de\/category\/wachsamkeit\/\" class=\"elementor-post-info__terms-list-item\">Wachsamkeit<\/a>\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c948f4 elementor-widget elementor-widget-elementskit-heading\" data-id=\"3c948f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"elementskit-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"ekit-wid-con\" ><div class=\"ekit-heading elementskit-section-title-wraper text_left   ekit_heading_tablet-   ekit_heading_mobile-\"><h2 class=\"ekit-heading--title elementskit-section-title \">[VEILLE] 61. Wissenschaftstagung der SFPM<\/h2><div class=\"ekit_heading_separetor_wraper ekit_heading_elementskit-border-divider ekit-dotted\"><div class=\"elementskit-border-divider ekit-dotted\"><\/div><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e0991b0 elementor-widget elementor-widget-text-editor\" data-id=\"e0991b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tDie ANSM hat ihren Anwendungsleitfaden ver\u00f6ffentlicht, der einige Punkte des Anhangs zum Beschluss vom 15. Januar 2020 zur Festlegung der Modalit\u00e4ten der Qualit\u00e4tskontrolle von Einrichtungen f\u00fcr die digitale Mammographie erg\u00e4nzt und anpasst, um die Umsetzung zu erleichtern. <br><strong>Die Entscheidung vom 15. Januar 2020 ist seit dem 15. Januar 2021 anwendbar.\n\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a01727 elementor-widget elementor-widget-heading\" data-id=\"3a01727\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Interesse an der Studie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d0b6b8 elementor-widget elementor-widget-text-editor\" data-id=\"5d0b6b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Der Beschluss sieht vor, dass bei einem Wechsel der R\u00f6hre die folgenden Tests im Rahmen der IQC durchgef\u00fchrt werden:<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cf8291 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"0cf8291\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"icon icon-right-arrow1\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">- <strong> 8.5.1\/8.12.1 \"Bestimmung der Erfassungsparameter\" <\/strong>bei Verwendung von PE- und PMMA-Platten in den St\u00e4rken 2,5 mm, 5 mm und 10 mm (240 mm x 320 mm)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"icon icon-right-arrow1\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">- <strong> 8.5.6\/8.12.2.2 \"Halbd\u00e4mpfungsschicht\" und 8.5.8\/8.12.6 \"Mittlere Dr\u00fcsendosis\"<\/strong> unter Verwendung eines Multimeters und ggf. Aluminiumplatten mit einer Gr\u00f6\u00dfe von mindestens 10 cm x 10 cm. Dennoch ist der Besitz dieser Materialien durch den Betreiber angesichts der zu erwartenden geringen H\u00e4ufigkeit dieser \u00c4nderungen nicht zwingend erforderlich. Bei der Durchf\u00fchrung dieser Tests k\u00f6nnen die Ger\u00e4te des Anbieters, der das R\u00f6hrchen gewechselt hat, verwendet werden.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-870e793 elementor-widget elementor-widget-text-editor\" data-id=\"870e793\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div>\n<p><strong>Diese Tests sind auch bei einer \u00c4nderung der Softwareversion durchzuf\u00fchren, durch die sich die Projektionsdosis \u00e4ndert.<\/strong><\/p>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-167af6b elementor-widget elementor-widget-heading\" data-id=\"167af6b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Interesse an der Studie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7f234d elementor-widget elementor-widget-text-editor\" data-id=\"c7f234d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Von nun an soll eine neue Kontrolle intern durchgef\u00fchrt werden: <strong>8.12.5.4 (Homogenit\u00e4t des rekonstruierten Tomosynthesebildes und SNR-Verfolgung).<\/p>\n<p><\/strong>Die Entscheidung erlaubt die Verwendung eines 45 mm dicken PMMA-Blocks, wenn der vom Hersteller gelieferte dedizierte Block f\u00fcr die Kalibrierung des Mammographieger\u00e4ts an der R\u00f6hre verwendet werden soll. Es ist auch m\u00f6glich, einen Satz PMMA-Platten mit einer Gesamtdicke von 45 mm zu verwenden.<\/p>\n<p>Au\u00dferdem ist zu beachten, dass die Abmessungen des PMMA-Blocks oder der Plattenanordnung mit einer Dicke von 45 mm 240 mm x 320 mm betragen. Mit anderen Worten: Wenn das Kalibrierungsphantom des Herstellers auf Potter-Ebene verwendet werden soll, muss es auch f\u00fcr den IQC verwendet werden.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21264dc elementor-widget elementor-widget-text-editor\" data-id=\"21264dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Der Beschluss enth\u00e4lt die Software, die f\u00fcr die Kontrolle der Homogenit\u00e4t des Empf\u00e4ngers, der Homogenit\u00e4t des rekonstruierten Tomosynthesebildes und die \u00dcberwachung der SNR sowie f\u00fcr die Kontrolle nicht korrigierter fehlerhafter Elemente erforderlich ist, wie in Abschnitt 8.12.5.4 erw\u00e4hnt. Tats\u00e4chlich erfordert im Rahmen der internen Qualit\u00e4tskontrolle nur der in 8.12.5.4 erw\u00e4hnte Test der Homogenit\u00e4t des rekonstruierten Tomosynthesebildes und die Verfolgung der SNR die Verwendung einer Software. Diese Software kann insbesondere vom Hersteller auf der Erfassungskonsole des Mammographen oder des Plattenleseger\u00e4ts zur Verf\u00fcgung gestellt werden.<\/p>\n<p>Andernfalls kann die Flatfield-Software verwendet werden, die vom LRCB angeboten wird und auf der Website der <span style=\"color: #0000ff;\"><strong><span style=\"text-decoration: underline;\"><a style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/www.ansm.sante.fr\/\" target=\"_blank\" rel=\"noopener\">der ANSM<\/a><\/span><\/strong><\/span>. <strong>Wenn die Software vor Ort nicht verf\u00fcgbar ist, kann das EQC bis zur Installation der besagten Software keine Nichtkonformit\u00e4t zu diesem Punkt ausstellen.<\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab00ec5 elementor-widget elementor-widget-text-editor\" data-id=\"ab00ec5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div>Herunterladen der <span style=\"color: #0000ff;\"><strong><span style=\"text-decoration: underline;\"><a style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/www.alara-expertise.fr\/wp-content\/uploads\/2021\/03\/CQI-Mammo-annexe.pdf\">\u00dcbersichtstabelle f\u00fcr interne IQKs<\/a> <br \/><\/span><\/strong><\/span><\/div>\n<div> <\/div>\n<div>Alle Informationen \u00fcber den<strong><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff; text-decoration: underline;\"><span id=\"OBJ_PREFIX_DWT214_com_zimbra_url\" class=\"Object\" role=\"link\"><a style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/www.ansm.sante.fr\/Activites\/Maintenance-et-controle-qualite-des-dispositifs-medicaux\/Controle-des-installations-de-mammographies-analogique-et-numerique\/%28offset%29\/2\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">QC Mammo finden Sie auf der Seite der ANSM<\/a><\/span><\/span><\/span><\/strong><\/div>\n<div> <\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e75b27e elementor-widget elementor-widget-text-editor\" data-id=\"e75b27e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div><strong>Unsere Experten stehen Ihnen gerne zur Verf\u00fcgung, z\u00f6gern Sie nicht, sie zu kontaktieren :<\/strong><\/div>\n<div>\n<div>03 69 09 21 30<\/div>\n<div><strong><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff;\"><a class=\"orange\" style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/www.alara-expertise.fr\/blog\/nous-contacter\">info@alara-expertise.fr<\/a><\/span><\/span><\/strong><\/div>\n<div> <\/div>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div 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Januar 2020 zur Festlegung der Modalit\u00e4ten der Qualit\u00e4tskontrolle von Einrichtungen f\u00fcr die digitale Mammographie erg\u00e4nzt und anpasst, um die Umsetzung zu erleichtern.<\/p>\n","protected":false},"author":1,"featured_media":8013,"comment_status":"closed","ping_status":"open","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[29],"tags":[],"class_list":["post-8006","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-wachsamkeit"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Entwicklung der Qualit\u00e4tskontrollen von Mammographieeinrichtungen<\/title>\n<meta name=\"description\" content=\"Die ANSM hat ihren Leitfaden f\u00fcr die Modalit\u00e4ten der Qualit\u00e4tskontrolle von digitalen Mammografieanlagen ver\u00f6ffentlicht, um die Umsetzung zu erleichtern.\" \/>\n<meta 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