{"id":12884,"date":"2020-08-07T12:41:53","date_gmt":"2020-08-07T12:41:53","guid":{"rendered":"https:\/\/bengalnewstimes.com\/?p=12884"},"modified":"2020-08-07T12:41:53","modified_gmt":"2020-08-07T12:41:53","slug":"who-information-notice-for-users-of-medical-devices-2020-3","status":"publish","type":"post","link":"https:\/\/bengalnewstimes.com\/?p=12884","title":{"rendered":"WHO Information Notice for Users of Medical Devices 2020\/3"},"content":{"rendered":"<p><\/p>\n<div id=\"\">\n<div>\n<h2 style=\"text-align:center;\"\/>\n<h2 style=\"text-align:center;\"\/>\n<p><strong>Date<\/strong>: 7 August 2020<\/p>\n<p><strong>Subject:<\/strong> Substandard\/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemic<\/p>\n<p><strong>WHO-identifier: <\/strong>2020\/3, version 1 <\/p>\n<p><strong>Type of action: <\/strong>Advice to <span style=\"text-decoration:underline;\">users<\/span> of medical devices and PPE used for prevention, treatment and care for COVID-19.<\/p>\n<p><strong>Attention<\/strong>: Users of medical devices and PPE<a data-sf-ec-immutable=\"\" href=\"https:\/\/worldhealthorg.sharepoint.com\/sites\/Incidents&amp;amp;SFMedicines\/Shared%20Documents\/IVDs%20and%20MDs\/DOCUMENTS\/WHO%20Info%20Notice%20for%20Users\/2020_03%20COVID%20MDs\/20%2008%2007%20WHO%20INFORMATION%20NOTICE%20FOR%20USERS_2020_03_v1.doc#_ftn1\" name=\"_ftnref1\" title=\"\">[1]<\/a>, procurement entities and customs officials, national programme managers and their implementing partners, laboratories, ministry of health and national regulatory authorities for medical devices and PPE. <\/p>\n<p>Purpose: To advise on actions to be taken to identify and prevent circulation of substandard\/falsified medical devices and PPE for COVID-19. \u00a0<\/p>\n<p>Description of the problem:<\/p>\n<p>WHO continues to be made aware of circulation of substandard\/falsified medical devices and PPE for prevention of COVID-19 and in the treatment and case management of people with COVID-19. <\/p>\n<p>WHO uses the following definitions:<\/p>\n<ul>\n<li><strong>Substandard<\/strong>,\u00a0also called &#8220;out of specification&#8221;, are authorized medical devices that fail to meet either their quality or safety performance specifications.<\/li>\n<li><strong>Falsified<\/strong>\u00a0medical device that deliberately\/fraudulently misrepresent their identity, composition or source.<\/li>\n<li><strong>Unregistered\/unlicensed<\/strong>\u00a0medical devices that have not undergone evaluation and\/or approval by the national regulatory authority for the market in which they are marketed\/distributed or used, subject to permitted conditions under national regulation and legislation.<\/li>\n<\/ul>\n<p>Any adverse event or product problem for a medical device may reveal that a product is substandard or falsified. \u00a0<\/p>\n<p><strong>Advice on action to be taken by <span style=\"text-decoration:underline;\">buyers\/donors<\/span> of medical devices and PPE for COVID-19:<\/strong><\/p>\n<ol>\n<li>Purchase products that have been authorized\/approved\/listed by the responsible institution: the national regulatory authority (NRA) or any other institution that has the mandate to oversee quality, safety and performance of such medical devices and PPE in your country. <\/li>\n<li>Review registration status by checking your NRA\u2019s website for lists\/databases of authorized\/approved\/listed products, and list of withdrawn\/non-approved products. If such information is not publicly available on their websites, communication with your NRA is encouraged.<\/li>\n<li>Ensure donated medical devices and PPE are registered (see <span style=\"text-decoration:underline;\"><a data-sf-ec-immutable=\"\" href=\"https:\/\/www.who.int\/medical_devices\/management_use\/manage_donations\/en\/\"><span style=\"text-decoration:underline;\">WHO guidelines<\/span><\/a>).<\/span> <\/li>\n<li>Purchase products from the legal manufacturer, or their designated economic operator (agent, distributor, supplier, authorized representative). <\/li>\n<li>Request from the manufacturer if any obsolescence plans are in place. <\/li>\n<\/ol>\n<p><strong>Advice on action to be taken by <span style=\"text-decoration:underline;\">users<\/span> of medical devices and PPE for COVID-19:<\/strong> <\/p>\n<ol>\n<li>Follow guidance from WHO on appropriate use of medical devices for COVID-19 T and use <span style=\"text-decoration:underline;\"><a data-sf-ec-immutable=\"\" href=\"https:\/\/www.who.int\/medical_devices\/priority\/COVID-19\/en\/\"><span style=\"text-decoration:underline;\">technical specifications provided by WHO<\/span><\/a><\/span> or the final user to select the appropriate, safe and qualified medical device. <a data-sf-ec-immutable=\"\" href=\"https:\/\/www.who.int\/medical_devices\/priority\/COVID-19\/en\/\"\/><\/li>\n<li>Avoid purchasing medical devices online from an unknown source. <\/li>\n<li>Request a copy of the <span style=\"text-decoration:underline;\">certificate of safety and performance depending on the functionality of the product from the manufacturer<\/span> for each lot\/serial number of product.<\/li>\n<li>Cross-reference the labelling of product received against your NRA\u2019s authorization\/approval\/listing letter and labelling on your NRA\u2019s website and the manufacturer\u2019s website. <\/li>\n<li>Conduct incoming inspection for certain categories of medical devices. <\/li>\n<li>Read the instructions for use to understand the intended use of the product and taking note of any limitations.<\/li>\n<li>Ascertain, within reasonable doubt, that the product is genuine. Contact WHO, if in doubt<a data-sf-ec-immutable=\"\" href=\"https:\/\/worldhealthorg.sharepoint.com\/sites\/Incidents&amp;amp;SFMedicines\/Shared%20Documents\/IVDs%20and%20MDs\/DOCUMENTS\/WHO%20Info%20Notice%20for%20Users\/2020_03%20COVID%20MDs\/20%2008%2007%20WHO%20INFORMATION%20NOTICE%20FOR%20USERS_2020_03_v1.doc#_ftn2\" name=\"_ftnref2\" title=\"\">[2]<\/a>.<\/li>\n<li>Run all required calibration and preventive maintenance procedures as instructed by the manufacturer in their instructions for use and operation manuals. <\/li>\n<li>Report any product problems and\/or adverse events as complaints to the manufacturer as soon as you become aware using a<span style=\"text-decoration:underline;\"> <a data-sf-ec-immutable=\"\" href=\"https:\/\/www.who.int\/diagnostics_laboratory\/procurement\/200420_amdf_reporting_form_md_and_ivds_v2.pdf\"><span style=\"text-decoration:underline;\">complaint<\/span><span style=\"text-decoration:underline;\"> form<\/span><\/a><\/span> and copy to WHO and your NRA. The contact details for the manufacturer can be found in both primary and secondary packaging materials and instructions for use.<\/li>\n<\/ol>\n<table>\n<tbody>\n<tr style=\"height:100%;\">\n<td style=\"width:50%;\">\n<p>Adverse events may be:<\/p>\n<ul>\n<li>Death of the patient, end-user or any other person occurred or may have occurred <\/li>\n<\/ul>\n<ul>\n<li>Death of the patient, end-user or any other person occurred or may have occurred<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<\/td>\n<td style=\"width:50%;\">\n<p>Product problems may be:<\/p>\n<ul>\n<li>Packaging \u2013 damaged, defective, suspect tampered<\/li>\n<li>Labelling \u2013 insufficient instructions for use, illegible<\/li>\n<li>Sampling \u2013 device does not collect\/transfer specimen<\/li>\n<li>Liquid \u2013 leak, splash<\/li>\n<li>Mechanical \u2013 misalignment, jam<\/li>\n<li>Electrical \u2013 unable to charge, power loss or fluctuation<\/li>\n<li>Data \u2013 capture, display, or storage affecting product\u00a0\u00a0\u00a0\u00a0 functionality<\/li>\n<li>Software \u2013 network, program, algorithm, or security affecting product functionality<\/li>\n<li>Environmental \u2013 noise, temperature, humidity\/moisture, fungal\/bacterial growth, or dust affecting product functionality<\/li>\n<li>Failure to calibrate<\/li>\n<li>Increased rate of invalid or unreturnable test results<\/li>\n<li>Obviously incorrect, inadequate or imprecise result or readings<\/li>\n<li>Unable to obtain reading<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong style=\"background-color:transparent;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;\">Advice for action to be taken by national <span style=\"text-decoration-line:underline;\">regulators<\/span> of medical devices and PPE for COVID-19:<\/strong><\/p>\n<ol>\n<li>Assess products (full assessment or through reliance\/recognition mechanisms) and share approval\/authorization\/listing on your website or any other platform which is accessible to stakeholders. Ensure such assessment is conducted before issuance of import permit for non-domestically manufactured product. \u00a0<\/li>\n<li>Conduct inspection of imported products in collaboration with customs officials at the point of entry to detect substandard\/falsified devices and products. The following information can be checked; import certificate issued by the NRA, certificate of analysis (translated) which needs to be compared with the imported products. Physical examination of products including labelling information and details of the importer (authorized representatives or approved suppliers), matching of product details with certificate of analysis, evidence of tampering of labels, language, product description such as size, shape, colour, product code and batch, cracks, abrasion, erosion, breaks and seal integrity.<\/li>\n<li>Collect samples for further investigation if there is any suspicion about the product and take appropriate regulatory actions such as quarantine and testing. <\/li>\n<li>Ensure that users are aware that they should report any adverse event and product problems to the manufacturer.\u00a0\u00a0<\/li>\n<li>Post field safety notices issued by manufacturers for medical devices and PPE supplied within your jurisdiction on your website.<\/li>\n<li>Exchange information with other regulators if your market surveillance detects product problems or adverse events.\u00a0 <strong\/><\/li>\n<\/ol>\n<p><strong>\u00a0<\/strong><\/p>\n<div>\n<p><em>Note: For many jurisdictions, emergency use\/approval mechanisms have been put in place for certain medical devices. These products should be the subject of increased monitoring by device users for adverse events and product problems.<\/em><\/p>\n<p><\/div>\n<div>\n<div id=\"ftn1\">\n<p><a data-sf-ec-immutable=\"\" href=\"https:\/\/worldhealthorg.sharepoint.com\/sites\/Incidents&amp;amp;SFMedicines\/Shared%20Documents\/IVDs%20and%20MDs\/DOCUMENTS\/WHO%20Info%20Notice%20for%20Users\/2020_03%20COVID%20MDs\/20%2008%2007%20WHO%20INFORMATION%20NOTICE%20FOR%20USERS_2020_03_v1.doc#_ftnref1\" name=\"_ftn1\" title=\"\">[1]<\/a> WHO previously published a WHO Information Notice for Users for falsified in vitro diagnostics (IVDs) used to diagnose COVID-19, see<a data-sf-ec-immutable=\"\" href=\"https:\/\/www.who.int\/diagnostics_laboratory\/procurement\/200422_who_info_covid_falsified_ivds_en.pdf?ua=1\"><span style=\"text-decoration:underline;\">WHO Information for Users n\u00b02\/2020<\/span><\/a><span style=\"text-decoration:underline;\">.<\/span><\/p>\n<p>Some PPE elements are classified as medical devices in some jurisdictions.<\/p>\n<\/div>\n<div id=\"ftn2\">\n<p><a data-sf-ec-immutable=\"\" href=\"https:\/\/worldhealthorg.sharepoint.com\/sites\/Incidents&amp;amp;SFMedicines\/Shared%20Documents\/IVDs%20and%20MDs\/DOCUMENTS\/WHO%20Info%20Notice%20for%20Users\/2020_03%20COVID%20MDs\/20%2008%2007%20WHO%20INFORMATION%20NOTICE%20FOR%20USERS_2020_03_v1.doc#_ftnref2\" name=\"_ftn2\" title=\"\"><strong>[2]<\/strong><\/a> Contact for further information: Anita SANDS, Regulation and Safety, e-mail: <a data-sf-ec-immutable=\"\" href=\"https:\/\/www.who.int\/mailto:sandsa@who.int\">sandsa@who.int<\/a><\/p>\n<\/div>\n<\/div>\n<p style=\"text-align:center;\"><span style=\"background-color:initial;color:#333333;font-size:inherit;font-family:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;\">\u00a0<\/span><\/p>\n<\/div>\n<p>&#13;\n    <\/p><\/div>\n<p><a href=\\\"https:\/\/www.who.int\/news-room\/detail\/07-08-2020-who-information-notice-for-users-of-medical-devices-2020-3\\\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Date: 7 August 2020 Subject: Substandard\/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemic WHO-identifier: 2020\/3, version 1 Type of action: Advice to users of medical devices and PPE used for prevention, treatment and care for COVID-19. Attention: Users of medical devices and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"spay_email":"","footnotes":""},"categories":[11],"tags":[],"class_list":["post-12884","post","type-post","status-publish","format-standard","hentry","category-health-life-style"],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/posts\/12884","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=12884"}],"version-history":[{"count":0,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/posts\/12884\/revisions"}],"wp:attachment":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12884"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12884"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12884"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}