{"id":11050,"date":"2024-12-11T15:19:26","date_gmt":"2024-12-11T14:19:26","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-3-umgang-mit-risiken-und-chancen\/5-3-03-vorkommnisse-bei-medizinprodukten\/"},"modified":"2025-02-04T13:38:18","modified_gmt":"2025-02-04T12:38:18","slug":"5-3-03-incidents-involving-medical-devices","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-3-umgang-mit-risiken-und-chancen\/5-3-03-vorkommnisse-bei-medizinprodukten\/","title":{"rendered":"5.3.03 Incidents involving medical devices"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Goal and purpose<\/h2>\n\n\n\n<p>Notification of the Managing Director, the members of the Board of Directors and the Clinic Directors of special incidents on the premises and in the operation of the hospital. The notification must be made without delay using the reporting channels described so that the management can take appropriate countermeasures and possibly inform the public.&nbsp;<em>DIN EN ISO 6.1, 10.2.1; JCI QPS.7;<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendung\">Application<\/h2>\n\n\n\n<p>Users and operators of medical devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung_des_ablaufes\">Description of the process<\/h2>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-e53fa029-1de5-4a88-a8ec-e2f532ec0c2c\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.03_00_qm_meldung_mpg.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">see VA 5.3.03 <\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.03_00_qm_meldung_mpg.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e53fa029-1de5-4a88-a8ec-e2f532ec0c2c\">Download<\/a><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">6 Notes and comments<\/h2>\n\n\n\n<p>Note the batch and serial numbers of accessories (e.g. ventilation tubes) and keep the accessories for reference.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">7 Applicable documents<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"vorschriften\">7.1 Regulations<\/h4>\n\n\n\n<p><a href=\"http:\/\/www.gesetze-im-internet.de\/mpamiv\/\" target=\"_blank\" rel=\"noreferrer noopener\">Medical Devices User Notification and Information Ordinance - MPAMIV<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">7.2 Terms<\/h4>\n\n\n\n<p><strong>64th occurrence<\/strong><br>A malfunction or deterioration in the characteristics or performance of a product already made available on the market, including application errors due to ergonomic features, as well as an inadequacy of the information provided by the manufacturer or an undesirable side effect;<br><strong>65. serious incident<\/strong>&nbsp;An incident that has had, could have had or could have had, directly or indirectly, any of the following consequences: a) the death of a patient, user or other person, b) the temporary or permanent serious deterioration in the state of health of a patient, user or other person, c) a serious risk to public health<br>Medical Devices Directive EU) 2017\/745 Article 2<\/p>\n\n\n\n<p><strong>Suspected serious incident<\/strong><br>an occurrence which cannot be excluded as being due to an undesirable side effect of a product, a malfunction, a deterioration in the characteristics or performance of a product, including errors in use due to ergonomic features or an inadequacy in the information provided by the manufacturer, and which directly or indirectly had or could have had one of the following consequences:<br>1. the death of a patient, user or other person,<br>2. the temporary or permanent serious deterioration in the state of health of a patient, user or other person, or<br>3. a serious risk to public health.<br>MPAMIV:2021 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h3>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-40ee74a4-b842-496b-bd35-77795e43d025\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.03_03_qm_meldung_mpg_intern.doc\" target=\"_blank\" rel=\"noreferrer noopener\">Internal registration form<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.03_03_qm_meldung_mpg_intern.doc\" class=\"wp-block-file__button wp-element-button\" aria-describedby=\"wp-block-file--media-40ee74a4-b842-496b-bd35-77795e43d025\" download>Download<\/a><\/div>\n\n\n\n<p>Reporting of incidents and SAEs involving medical devices via the DIMDI&nbsp;<a href=\"https:\/\/www.dimdi.de\/static\/de\/mpg\/ismp\/meld\/index.htm\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.dimdi.de\/static\/de\/mpg\/ismp\/meld\/index.htm<\/a>&nbsp;Here you can find the forms for notifications and the corresponding regulations<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Ziel und Zweck Benachrichtigung des Gesch\u00e4ftsf\u00fchrers, der Mitglieder des Direktoriums und der Klinikdirektoren \u00fcber Besondere Vorkommnisse auf dem Gel\u00e4nde und im Betrieb des Krankenhauses. Die Benachrichtigung muss ohne Verzug auf dem beschriebenen Meldewege erfolgen, damit die Leitung geeignete Gegenma\u00dfnahmen ergreifen und eventuell die \u00d6ffentlichkeit informieren k\u00f6nnen.\u00a0DIN EN ISO 6.1, 10.2.1; JCI QPS.7; Anwendung Anwender und [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":11044,"menu_order":62,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11050","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11050","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=11050"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11050\/revisions"}],"predecessor-version":[{"id":15090,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11050\/revisions\/15090"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11044"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11050"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11050"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}