{"id":8007,"date":"2023-07-25T16:36:53","date_gmt":"2023-07-25T14:36:53","guid":{"rendered":"https:\/\/alara-group.fr\/?p=8007"},"modified":"2023-08-02T10:34:38","modified_gmt":"2023-08-02T08:34:38","slug":"veille-new-regulations-for-quality-control-of-mammography-facilities","status":"publish","type":"post","link":"https:\/\/alara-group.fr\/en\/veille-new-regulations-for-quality-control-of-mammography-facilities\/","title":{"rendered":"[VEILLE] New regulations for quality control of mammography facilities"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8007\" class=\"elementor elementor-8007 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\/en\/category\/monitoring\/\" class=\"elementor-post-info__terms-list-item\">Monitoring<\/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] The impact of acceleration factors in 4D flow MRI<\/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\tANSM has published its application guide, which supplements and adapts certain points in the appendix to the January 15, 2020 decision setting out the quality control procedures for digital mammography facilities, in order to facilitate its implementation. <br><strong>The decision of January 15, 2020 applies from January 15, 2021.\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\">Interest of the study<\/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>In the event of a tube change, the decision provides for the following tests to be carried out as part of the IQC:<\/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 \"Determination of acquisition parameters\" <\/strong>using PE and PMMA sheets with thicknesses of 2.5 mm, 5 mm and 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 \"Half-attenuation layer\" and 8.5.8\/8.12.6 \"Mean glandular dose\"<\/strong> with the use of a multimeter and, where appropriate, aluminum plates with dimensions of at least 10 cm x 10 cm. However, it is not compulsory for the operator to own this equipment, given the expected low frequency of such changes. When carrying out these tests, the equipment of the service provider who changed the tube can be used.<\/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>These tests should also be carried out when a software version is changed, modifying the projection dose.<\/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\">Interest of the study<\/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>From now on, a new control is to be carried out internally: <strong>8.12.5.4 (Homogeneity of reconstructed tomosynthesis image and SNR monitoring).<\/p>\n<p><\/strong>The decision allows the use of a 45 mm thick PMMA block if the dedicated mammography calibration block supplied by the manufacturer is to be used at tube level. A set of PMMA sheets with a total thickness of 45 mm can also be used.<\/p>\n<p>It should also be noted that the dimensions of the PMMA block or 45 mm thick sheet assembly are 240 mm x 320 mm. In other words, if the manufacturer&#8217;s calibration phantom is to be used at Potter level, it must be used for IQC.<\/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>The decision mentions the software needed to check receiver homogeneity, the homogeneity of the reconstructed tomosynthesis image and SNR monitoring, and to check for uncorrected defective elements, as mentioned in point 8.12.5.4. In fact, as part of internal quality control, only the test of reconstructed tomosynthesis image homogeneity and SNR monitoring mentioned in section 8.12.5.4 requires the use of software. In particular, this software can be made available by the manufacturer on the acquisition console of the mammograph or plate reader.<\/p>\n<p>If this is not the case, you can use the Flatfield software proposed by the LRCB and available on the <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\">ANSM<\/a><\/span><\/strong><\/span>. <strong>If the software is not available on site, the EQC cannot issue a non-conformity on this point, pending installation of the software.<\/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>Download the <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\">internal IQC summary table<\/a> <br \/><\/span><\/strong><\/span><\/div>\n<div> <\/div>\n<div>All information concerning<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\">Mammo CQ are available on the ANSM page<\/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>Our experts are at your disposal, so don&#8217;t hesitate to contact them:<\/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 class=\"elementor-element elementor-element-0956250 elementor-widget 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