{"id":1800,"date":"2017-10-31T14:23:17","date_gmt":"2017-10-31T14:23:17","guid":{"rendered":"https:\/\/malmed.gov.mk\/?page_id=1800"},"modified":"2021-02-05T08:06:36","modified_gmt":"2021-02-05T08:06:36","slug":"%d0%be%d1%81%d0%bd%d0%be%d0%b2%d0%bd%d0%b8-%d0%b8%d0%bd%d1%84%d0%be%d1%80%d0%bc%d0%b0%d1%86%d0%b8%d0%b8-%d0%b7%d0%b0-%d0%bc%d0%b0%d1%82%d0%b5%d1%80%d0%b8%d0%be%d0%b2%d0%b8%d0%b3%d0%b8%d0%bb%d0%b0","status":"publish","type":"page","link":"https:\/\/malmed.gov.mk\/sq\/%d0%be%d1%81%d0%bd%d0%be%d0%b2%d0%bd%d0%b8-%d0%b8%d0%bd%d1%84%d0%be%d1%80%d0%bc%d0%b0%d1%86%d0%b8%d0%b8-%d0%b7%d0%b0-%d0%bc%d0%b0%d1%82%d0%b5%d1%80%d0%b8%d0%be%d0%b2%d0%b8%d0%b3%d0%b8%d0%bb%d0%b0\/","title":{"rendered":"Informacionet themelore p\u00ebr Materiovigjilenc\u00ebn"},"content":{"rendered":"

Agjencia e Barnave dhe Pajisjeve Mjek\u00ebsore n\u00eb Republik\u00ebn e Maqedonis\u00eb s\u00eb Veriut \u2013 MALMED, sipas nenit 138 t\u00eb Ligjit t\u00eb Barnave dhe Pajisje Mjek\u00ebsore (\u201cGazeta Zyrtare e RMV-s\u00eb\u201d, nr. 106\/07. 88\/ 10, 36\/11, 53\/11, 136\/11, 11\/12, 147\/13, 164\/13, 27\/14, 43\/14, 88\/15, 154\/15, 228\/15, 07\/16 \u0438 53\/16), vendos dhe mir\u00ebmban sistemin materiovigjilent me baz\u00eb t\u00eb t\u00eb dh\u00ebnave p\u00ebr zbulimin, mbledhjen, monitorimin, vler\u00ebsimin dhe sigurin\u00eb e p\u00ebrshtatshm\u00ebris\u00eb e t\u00eb dh\u00ebnave t\u00eb reja p\u00ebr siguri t\u00eb pajisjeve mjek\u00ebsore ose p\u00ebr pajisjet mjek\u00ebsore t\u00eb testuara, si dhe marr\u00ebdh\u00ebniet rreziku\/ p\u00ebrfitimi nga p\u00ebrdorimi i pajisjeve mjek\u00ebsore ose interaksionet e saja.<\/p>\n

Raportimi p\u00ebr reaksionet an\u00ebsore t\u00eb pajisjeve mjek\u00ebsore e paraqesin:<\/p>\n

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  1. Prodhuesi ose bart\u00ebsi i autorizuar p\u00ebr regjistrimin e pajisjeve mjek\u00ebsore n\u00eb Regjistrin e pajisjeve mjek\u00ebsore;<\/li>\n
  2. P\u00ebrdoruesit (shfryt\u00ebzuesit)e pajisjeve mjek\u00ebsore(institucionet sh\u00ebndet\u00ebsore, pun\u00ebtor\u00ebt sh\u00ebndet\u00ebsor\u00eb dhe pacient\u00ebt);<\/li>\n
  3. Pal\u00ebt e treta (psh. Distributorii prodhuesit t\u00eb pajisjeve mjek\u00ebsore ose tregtia n\u00eb shumic\u00eb)<\/li>\n<\/ol>\n

    Nga ana e institucioneve sh\u00ebndet\u00ebsore dhe punonj\u00ebsve sh\u00ebndet\u00ebsor\u00eb deri te Agjencia njoftohet duke raportuar p\u00ebr t\u00eb gjith\u00eb:<\/p>\n

      \n
    1. Reaksionet an\u00ebsore ose ngjarje t\u00eb reja t\u00eb pajisjeve mjek\u00ebsore ose n\u00eb rast t\u00eb dyshimeve p\u00ebr reaksionet an\u00ebsore ose ngjarje, si dhe reaksionet\/ngjarjet q\u00eb nuk jan\u00eb serioze:<\/li>\n
    2. Reaksione serioze an\u00ebsore t\u00eb papritura t\u00eb pajisjeve mjek\u00ebsore (edhe at\u00ebher kur nuk jan\u00eb t\u00eb karakterit serioz) q\u00eb \u00ebsht\u00eb n\u00eb p\u00ebrdorim m\u00eb shum\u00eb se 5 vjet ose n\u00eb rast t\u00eb dyshimit t\u00eb k\u00ebtyre reaksioneve.<\/li>\n
    3. Informacionet p\u00ebr rritjen e incidenc\u00ebs s\u00eb manifestimit p\u00ebr reagim t\u00eb pritsh\u00ebm, interaksionet e r\u00ebnd\u00ebsishme klinike, keqp\u00ebrdorim t\u00eb pajisjeve mjek\u00ebsore, mbidozimi, p\u00ebrdorimi gjat\u00eb koh\u00ebs s\u00eb shtat\u00ebz\u00ebnis\u00eb dhe gji dh\u00ebnia, mungesa e efikasitetit, si dhe informacioni p\u00ebr gabimet mjek\u00ebsore.<\/li>\n<\/ol>\n

      Njoftimi p\u00ebr reaksionet an\u00ebsore prej pajisjeve mjek\u00ebsore, n\u00eb t\u00eb v\u00ebrtet\u00eb dyshimi p\u00ebr reaksionet an\u00ebsore t\u00eb pajisjeve mjek\u00ebsore nga ana e institucioneve sh\u00ebndet\u00ebsore dhe pun\u00ebtor\u00ebve sh\u00ebndet\u00ebsor kryhet me fletparaqitje p\u00ebr reaksionet an\u00ebsore t\u00eb pajisjeve mjek\u00ebsore.<\/p>\n

      Fletparaqitja p\u00ebrmban\u00eb t\u00eb dh\u00ebna p\u00ebr:<\/p>\n

        \n
      1. Pacienti (inicialet, mosha dhe gjinia) dhe reaksionet an\u00ebsore (data e fillimit t\u00eb reaksionit, p\u00ebrshkrim t\u00eb manifestimit klinik, rezultati dhe trajtimi eventual, lidhshm\u00ebria p\u00ebrmes reaksionit an\u00ebsor dhe pajisjes mjek\u00ebsore t\u00eb dyshuar);<\/li>\n
      2. Pajisja mjek\u00ebsore q\u00eb dyshohet dhe rrjedha e reaksioneve an\u00ebsore pas nd\u00ebrprerjes dhe\/ ose rip\u00ebrs\u00ebritja e pajisjeve mjek\u00ebsore t\u00eb dyshuara;<\/li>\n
      3. P\u00ebrdorimi n\u00eb t\u00eb njejt\u00ebn koh\u00eb i pajisjeve tjera ose barnave me dat\u00ebn e fillimit t\u00eb p\u00ebrdorimit dhe historia e pacient\u00ebve; dhe<\/li>\n
      4. Prodhuesi i Pajisjeve mjek\u00ebsore q\u00eb dyshohet (emri dhe shteti, numri i seris\u00eb) dhe aplikuesi i flet\u00ebparaqitjes (data e aplikimit, origjina dhe lloji i aplikimit, emri dhe mbiemri, telefoni i kontaktit, profesioni).<\/li>\n<\/ol>\n

        Bazuar n\u00eb t\u00eb dh\u00ebnat e tubuara p\u00ebr reaksionet an\u00ebsore t\u00eb pajisjeve mjek\u00ebsore dhe identifikimi i njohurive t\u00eb reja n\u00eb lidhje me sigurin\u00eb e saj, Agjencia e Pajisjeve Mjek\u00ebsore (MALMED) mundet me marr\u00eb masa me t\u00eb cilat siguron\u00eb siguri q\u00eb pajisjet mjek\u00ebsore p\u00ebrdoren n\u00eb at\u00eb m\u00ebnyr\u00eb q\u00eb eliminohet rreziku dhe potencohen p\u00ebrfitimet e t\u00eb nj\u00ebjt\u00ebs.<\/p>\n\n\n

        <\/p>\n\n\n\n

        <\/p>\n\n\n\n

        <\/p>\n\n\n\n

        <\/p>\n\n\n\n

        <\/p>\n\n\n\n

        <\/p>","protected":false},"excerpt":{"rendered":"

        \u0410\u0433\u0435\u043d\u0446\u0438\u0458\u0430\u0442\u0430 \u0437\u0430 \u043b\u0435\u043a\u043e\u0432\u0438 \u0438 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u043d\u0430 \u0420\u0435\u043f\u0443\u0431\u043b\u0438\u043a\u0430 \u041c\u0430\u043a\u0435\u0434\u043e\u043d\u0438\u0458\u0430 – \u041c\u0410\u041b\u041c\u0415\u0414, \u0441\u043e\u0433\u043b\u0430\u0441\u043d\u043e \u0447\u043b\u0435\u043d 138 \u043e\u0434 \u0417\u0430\u043a\u043e\u043d\u043e\u0442 \u0437\u0430 \u043b\u0435\u043a\u043e\u0432\u0438 \u0438 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 (,,\u0421\u043b\u0443\u0436\u0431\u0435\u043d \u0432\u0435\u0441\u043d\u0438\u043a \u043d\u0430 \u0420\u041c”, \u0431\u0440. 106\/07,\u00a088\/10, 36\/11,\u00a053\/11,\u00a0136\/11,\u00a011\/12, 147\/13, 164\/13, 27\/14, 43\/14, 88\/15, 154\/15, 228\/15, 07\/16 \u0438 53\/16), \u0432\u043e\u0441\u043f\u043e\u0441\u0442\u0430\u0432\u0443\u0432\u0430 \u0438 \u043e\u0434\u0440\u0436\u0443\u0432\u0430 \u0441\u0438\u0441\u0442\u0435\u043c \u043d\u0430 \u043c\u0430\u0442\u0435\u0440\u0438\u043e\u0432\u0438\u0433\u0438\u043b\u0430\u043d\u0446\u0430 \u0441\u043e \u0431\u0430\u0437\u0430 \u043d\u0430 \u043f\u043e\u0434\u0430\u0442\u043e\u0446\u0438 \u0437\u0430 \u043e\u0442\u043a\u0440\u0438\u0432\u0430\u045a\u0435, \u0441\u043e\u0431\u0438\u0440\u0430\u045a\u0435, \u0441\u043b\u0435\u0434\u0435\u045a\u0435, \u043f\u0440\u043e\u0446\u0435\u043d\u0430 \u0438 \u043e\u0431\u0435\u0437\u0431\u0435\u0434\u0443\u0432\u0430\u045a\u0435 […]<\/p>","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1800","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/pages\/1800","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/comments?post=1800"}],"version-history":[{"count":0,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/pages\/1800\/revisions"}],"wp:attachment":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/media?parent=1800"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}