{"id":11750,"date":"2015-09-09T06:00:09","date_gmt":"2015-09-09T04:00:09","guid":{"rendered":"https:\/\/www.johner-institut.de\/blog\/?p=11750"},"modified":"2025-04-23T18:21:05","modified_gmt":"2025-04-23T16:21:05","slug":"fda-maude","status":"publish","type":"post","link":"https:\/\/www.johner-institut.de\/blog\/regulatory-affairs\/fda-maude\/","title":{"rendered":"FDA MAUDE Datenbank: Input f\u00fcrs Risikomanagement"},"content":{"rendered":"<div class=\"blog-column\">Die <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm\" target=\"_blank\" rel=\"noopener\">FDA MAUDE Datenbank<\/a> stellt\u00a0Informationen zur &#8222;Manufacturer and User Facility Device Experience&#8220; bereit. Sie entspricht damit etwa der <a href=\"https:\/\/www.johner-institut.de\/blog\/category\/iec-62304-medizinische-software\/\" target=\"_blank\" rel=\"noopener\">Datenbank, mit der das BfArM Meldungen von Hersteller zur Risiken<\/a> publiziert.<\/div>\n<div class=\"blog-column\">\n<table class=\"table-blog\">\n<tbody>\n<tr>\n<th class=\"table-blog-header\"><i class=\"fa fa-play\" style=\"color: red;\" aria-hidden=\"true\"> \u00a0<\/i>Inhalts\u00fcbersicht<\/th>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/www.johner-institut.de\/blog\/fda\/fda-maude\/#inhalt\">Inhalt der MAUDE Datenbank \u00bb<\/a><\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/www.johner-institut.de\/blog\/fda\/fda-maude\/#auswertung\">Neues Werkzeug zur Auswertung \u00bb<\/a><\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/www.johner-institut.de\/blog\/fda\/fda-maude\/#regulations\">Regulatorischer Hintergrund \u00bb<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"blog-clear\"><\/div>\n<p><!--more--><\/p>\n<h2 id=\"inhalt\">Inhalt der FDA MAUDE Datenbank<\/h2>\n<p>Die FDA MAUDE Datenbank enth\u00e4lt Informationen zu<\/p>\n<ul>\n<li>dem Problem<\/li>\n<li>der Produktklasse und Produkt-Code<\/li>\n<li>Der Auswirkung des Zwischenfalls (Tod, Verletzung, &#8230;) (&#8222;Event&#8220;)<\/li>\n<li>Hersteller<\/li>\n<li>Datum der Meldung<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.johner-institut.de\/blog\/wp-content\/uploads\/2015\/09\/FDA-MAUDE.jpg\" data-rel=\"lightbox-image-0\" data-rl_title=\"\" data-rl_caption=\"\" title=\"\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-11753\" src=\"https:\/\/www.johner-institut.de\/blog\/wp-content\/uploads\/2015\/09\/FDA-MAUDE.jpg\" alt=\"Suchmaske der FDA MAUDE Datenbank\" width=\"599\" height=\"212\" srcset=\"https:\/\/www.johner-institut.de\/blog\/wp-content\/uploads\/2015\/09\/FDA-MAUDE.jpg 599w, https:\/\/www.johner-institut.de\/blog\/wp-content\/uploads\/2015\/09\/FDA-MAUDE-300x106.jpg 300w\" sizes=\"auto, (max-width: 599px) 100vw, 599px\" \/><\/a><\/p>\n<h2 id=\"regulations\">Regulatorischer Hintergrund<\/h2>\n<h3>Pflicht zur Auswertung<\/h3>\n<p>Hersteller sind verpflichtet, ein ad\u00e4quates Risikomanagement zu betreiben. Das schlie\u00dft die \u00dcberwachung des Produkts im Markt, aber auch \u00e4hnlicher Produkte und Technologien mit ein. Nur so kann es Herstellern gelingen,<\/p>\n<ul>\n<li><a href=\"https:\/\/www.johner-institut.de\/blog\/iso-14971-risikomanagement\/gefaehrdung-und-gefaehrdungssitation\/\" target=\"_blank\" rel=\"noopener\">Gef\u00e4hrdungen<\/a> m\u00f6glichst vollst\u00e4ndig zu identifizieren,<\/li>\n<li>Wahrscheinlichkeiten von Sch\u00e4den und Problemen\u00a0sowie<\/li>\n<li><a href=\"https:\/\/www.johner-institut.de\/blog\/iso-14971-risikomanagement\/schweregrad-schaden-iso-14971\/\" target=\"_blank\" rel=\"noopener\">Schweregrade<\/a>\u00a0von Sch\u00e4den m\u00f6glichst korrekt abzusch\u00e4tzen.<\/li>\n<\/ul>\n<p>Die Datenbanken des BfArMs sowie die FDA MAUDE\u00a0z\u00e4hlen zu den Quellen, die Sie dabei immer\u00a0einbeziehen sollten &#8212; unabh\u00e4ngig davon, in welchem Rechtsraum Sie Ihre Produkte vermarketen.<\/p>\n<h3>Pflicht zur Meldung<\/h3>\n<p>Sowohl in den USA als auch in Europa m\u00fcssen sowohl Hersteller als auch Anwender Probleme und Zwischenf\u00e4lle melden. Die FDA schreibt hierzu:<\/p>\n<ul>\n<li><cite><strong>Manufacturers<\/strong> and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Manufacturers must send reports of such deaths, serious injuries and malfunctions to the FDA.<\/cite><\/li>\n<li><cite><strong>Importers<\/strong> must send reports of deaths and serious injuries to the FDA and the manufacturer, and reports of malfunctions to the manufacturer.<\/cite><\/li>\n<li><cite><strong>Device user facilities<\/strong> include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. Death reports must be sent to the FDA and the manufacturer, if known. Serious injury reports must be sent to the manufacturer or to the FDA, if the manufacturer is not known.<\/cite><\/li>\n<\/ul>\n<p>\u00c4nderungshistorie:<\/p>\n<ul>\n<li>2023-12-06: Verweis auf Maude-Analyzer des Johner Instituts entfernt<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Die FDA MAUDE Datenbank stellt\u00a0Informationen zur &#8222;Manufacturer and User Facility Device Experience&#8220; bereit. Sie entspricht damit etwa der Datenbank, mit der das BfArM Meldungen von Hersteller zur Risiken publiziert. \u00a0Inhalts\u00fcbersicht Inhalt der MAUDE Datenbank \u00bb Neues Werkzeug zur Auswertung \u00bb Regulatorischer Hintergrund \u00bb<\/p>\n","protected":false},"author":74,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1108],"tags":[1188],"ppma_author":[1213],"class_list":["post-11750","post","type-post","status-publish","format-standard","hentry","category-regulatory-affairs","tag-fda","category-1108","description-off"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA MAUDE Datenbank: Input f\u00fcrs Risikomanagement<\/title>\n<meta name=\"description\" content=\"Die FDA MAUDE Datenbank umfasst Meldungen zur &quot;Manufacturer and User Facility Device Experience&quot;. 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