{"id":52623,"date":"2023-02-18T11:15:38","date_gmt":"2023-02-18T05:45:38","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=52623"},"modified":"2023-02-18T11:16:03","modified_gmt":"2023-02-18T05:46:03","slug":"remanufacturing-of-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/","title":{"rendered":"A Complete Guideline on Remanufacturing of Medical Devices"},"content":{"rendered":"\n<p>As per the draft\nguidelines laid down by FDA (Food and Drugs Administration), \u201c<strong><em>Remanufacturing<\/em><\/strong>\u201d\nis defined as the process, conditions, refurbishes, replenishing, restoring or\nany other related act done towards the completion of final device that\nsignificantly changes the finished devices performance and conduct or safety\nspecification on intended use. In order to help ensure the continuous quality,\nsafety, and effectiveness of devices that are designed to be serviced\nthroughout the course of their useful life, remanufacturing of devices in the\nmedical industry is an important tool for the manufacturer. Remanufacturing of\ndevices using technologies can lead to amelioration in various developing\ncountries. In this article, we shall discuss the concept of Remanufacturing of medical devices, Medical\nGoods that can remanufactured, when\nit is done and what is the significance of remanufacturing<em>?<\/em> A\ndetailed discussion on the FDA issued guidelines on Remanufacturing of medical\ndevices.<\/p>\n\n\n\n<p>The effect of\nRemanufacturing on sustainability was assessed in the light of numerous\nsocio-economic conditions and as a result, single-use <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical devices<\/a><\/strong> were found to be very essential for reduction in Waste Management\nin the medical industry.&nbsp; The COVID-19\npandemic has increased the use of single-use devices, making this even more\nimportant. Cleaning was considered to be an important factor in providing a\nsecure and reliable remanufacturing process that would mitigate the risk of\ncontamination to patients. As a result, this procedure was scrutinized and\nsensible suggestions were offered henceforth.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/#Medical_Goods_That_Are_Eligible_For_Remanufacture\" >Medical Goods\nThat Are Eligible For Remanufacture<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/#Documents_Required_For_the_Remanufacturing_Of_Medical_Devices\" >Documents Required For the Remanufacturing Of Medical\nDevices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/#Process_for_Remanufacturing_of_Medical_Devices\" >Process for Remanufacturing of Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/#FDAs_Guidance_on_the_Remanufacturing_of_Medical_Devices\" >FDA\u2019s Guidance on the Remanufacturing of Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/#Suggestions_%E2%80%93_Remanufacturing_of_Medical_Devices\" >Suggestions \u2013 Remanufacturing of Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/remanufacturing-of-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Goods_That_Are_Eligible_For_Remanufacture\"><\/span>Medical Goods\nThat Are Eligible For Remanufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Both the list of\nproducts that can be remanufactured and the regulations governing what can and\ncannot be remanufactured are open to interpretation. Remanufacturing, however,\nfunctions best in the following areas: High-end, sophisticated products that are not sold on the\nbasis of a consumer\u2019s status or way of life.<\/p>\n\n\n\n<p><em>The list of remanufactured medical&nbsp;goods is mentioned\nbelow:<\/em><em><\/em><\/p>\n\n\n\n<ol><li>Surgical\n     instruments such as Clamps and Forceps,<\/li><li>Endoscopes such as Bronchoscope, Duodenoscopies,\n     and Colonoscopies, equipment that is used for visualization inside the\n     body,<\/li><li>Accessories for the endoscope, such as\n     graspers and scissors,<\/li><li>Laparoscopic surgery accessories such as\n     arthroscopic shavers <\/li><\/ol>\n\n\n\n<p>The draft guidelines offer a flowchart outlining\nthe methodology to be used and the factors to be taken into account to help\nmedical device manufacturers determine whether a specific activity falls under\nthe definition of &#8220;<strong><em>remanufacturing<\/em><\/strong>.&#8221; The flowchart\nsuggests that each modification (such as a physical change or modification to a\nsafety control) be evaluated separately to ascertain whether the activity is\nlikely to be remanufactured. A comparison to a medical device that has already\nbeen released on the market should be made in order to assess the impact that\nthe changes have had. All decisions made should be supported by adequate\ndocumentation. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_For_the_Remanufacturing_Of_Medical_Devices\"><\/span>Documents Required For the Remanufacturing Of Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The authority also highlights the need for\ndocumentation of the decision-making procedure itself. <\/p>\n\n\n\n<p><em>The documentation for the remanufacturing of\nMedical Devices should contain the following, as per the instructions:<\/em><\/p>\n\n\n\n<ul><li>Product name (if the relevant,\nmodel number and serial number);<\/li><li>Date of completed activities,\nevaluation, and determination;<\/li><li>Describe the gadget;<\/li><li>A description of the tasks to be\ncompleted, along with a list of the materials, parts, and components that will\nbe used;<\/li><li>Deciding if a particular operation\nis remanufacturing;<\/li><li>Citation of pertinent documents\nthat help the decision-making process.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Process_for_Remanufacturing_of_Medical_Devices\"><\/span>Process for Remanufacturing of Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The remanufacturing of Medical Devices is generally\ndivided into a six-stage procedure. These include: <\/p>\n\n\n\n<ul><li>Component\nremanufacturing, <\/li><li>Testing,<\/li><li>Assembling\n<\/li><li>Disassembling\n<\/li><li>Cleaning,\nand <\/li><li>Inspection<\/li><\/ul>\n\n\n\n<p>Each of these areas is essential to the overall process\nof remanufacturing of medical devices because it guarantees that a particular\nproduct will be rebuilt to a high standard and that the proper quality control\nmeasures will be put in place at each stage. Due to the high standards expected\nin the medical profession, the &#8220;Cleaning&#8221; stage was chosen to be of\nthe most demanded step for further remanufacturing. Although the cleaning\nprocedure is crucial for the medical industry as a whole, considering\nsingle-use medical devices makes its significance even more apparent. Single\nuse products in the medical sector can be used only once as the name depicts,\nand then it is to be disposed of, this does not sounds so effective from a\nsustainable point of view. Thus, remanufacturing of devices holds a very\ncrucial place in the medical industry.<\/p>\n\n\n\n<p>Remanufacturing of Medical Devices is a six-step\nprocess, as laid down by the guidelines of the FDA. The &#8220;<strong><em>cleaning<\/em><\/strong>&#8221;\nphase is crucial when it comes to medical devices. This is due to the fact that\nthe most, if not all, medical devices require sterilization. As parts can be\nclean but not sterile, sterilization is more industry-specific. When an\nequipment is sterilized, it is made sure to be clean and devoid of any\nmicrobes, such as bacteria or viruses.<\/p>\n\n\n\n<p><strong><em>Sterilization<\/em><\/strong><sup><a class=\"text-primary\" href=\"https:\/\/en.wikipedia.org\/wiki\/Sterilization_(microbiology)\"><strong>[1]<\/strong><\/a><\/sup> is a crucial factor to\ntake into account while remanufacturing medical equipment. The remanufacturer\nof the equipment must take into account the material&#8217;s potential short- and\nlong-term changes, its absorbency, if the sterilization procedure impacts the\ndevice&#8217;s intended use, and whether the sterilization process will touch all\ncontaminable parts of the item. The time and expense associated with this\nportion of the remanufacturing of medical equipment could be decreased with the\nintroduction of strict sterilizing procedures in any remanufacturing laws.<\/p>\n\n\n\n<p>The Food and Drug Administration (FDA) has\nhighlighted a number of actions taken on software that <strong><em>are probably not considered for\n\u201cRemanufacturing<\/em><\/strong>\u201d, because they generally do not significantly modify\nthe performance or safety parameters of the medical device, <\/p>\n\n\n\n<ol><li>Actions taken on behalf of or in\nany other way expressly approved by the Original Equipment Manufacturer(OEM)\nthat restore the legally sold product to its performance and safety\nspecifications, as well as its intended use;<\/li><li>Implementing the updates and upgrades\noffered by the OEM;<\/li><li>Running hardware diagnostics using\nsoftware;<\/li><li>Checking for malware, viruses, and\nother cybersecurity-related problems;<\/li><li>Reinstalling Original Equipment\nManufacturer(OEM) software to bring performance and safety back to their former\nlevels;<\/li><li>Software that returns to a\nprevious configuration;<\/li><li>Installing security upgrades that\nthe Original Equipment Manufacturer(OEM) has approved;<\/li><li>Evaluating the software inventory,\ngathering system logs, managing user accounts, and getting access to repair and\ndiagnostic data.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDAs_Guidance_on_the_Remanufacturing_of_Medical_Devices\"><\/span>FDA\u2019s Guidance on the Remanufacturing of Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>These six\n(6) guiding principles are included in the FDA&#8217;s guidance on the\nremanufacturing of medical devices and are intended to help establish if an\nentity&#8217;s activities are valid.<\/em><\/strong><\/p>\n\n\n\n<ol><li>Check to see if the intended use\nhas changed.<\/li><li>Ascertain if the individual and\ncombined effects of the actions significantly alter the safety or performance\nrequirements of a final product. The FDA states that it considers improvements\nto a device to be a &#8220;change.&#8221; Multiple adjustments should be assessed\nsince, when taken together, they may dramatically alter the device&#8217;s\nperformance or safety requirements.<\/li><li>In accordance with FDA&#8217;s guidance,\ndetermine whether any changes to a device necessitate a new marking submission,\nanalyze the dimensions of a component, part, or substance.<\/li><li>Analyze the dimensions and\nperformance requirements for the component, part, or material.<\/li><li>Use a risk-based approach to\ndecide whether a task qualifies as manufacturing if it significantly alters\nperformance or safety requirements.<\/li><li>Maintain adequate records of\ndecisions made in order to support them in the event that an FDA inspection\noccurs. The documentation should specifically state whether or not the actions\ntaken in relation to the device materially alter its intended usage,\nperformance, or safety requirements. Appendix B of the draft guidance contains\nexamples of this material provided by FDA.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Suggestions_%E2%80%93_Remanufacturing_of_Medical_Devices\"><\/span>Suggestions \u2013 Remanufacturing of Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>When a medical device is considered to be &#8220;<strong>remanufacturing<\/strong>,&#8221; all of the\nduties of a medical device manufacturer are taken into account, such as:<\/p>\n\n\n\n<ul><li>In\ncase a advanced and updated marketing submission is necessary;<\/li><\/ul>\n\n\n\n<ul><li>In\nthe case, the Original Equipment Manufacturer(OEM) or the remanufacturer learns\nof a reportable incident, Medical Device Reporting (MDR) is required;<\/li><\/ul>\n\n\n\n<ul><li>Listing\nand Registering of the medical devices is a necessary;<\/li><\/ul>\n\n\n\n<ul><li>Quality\nSystem Regulation (QSR) conformity. It is also known as FDA 21 CFR Part 820, is\na system that assures that the medical device meets the safety and quality\nstandard prerequisite. These system are in currently in trend and is called as\nCurrent Good Manufacturing Practices (CGMP).<\/li><\/ul>\n\n\n\n<ul><li>Obligations\nfor removals or corrections and reporting; and<\/li><\/ul>\n\n\n\n<ul><li>General\nrules against adulteration and misbranding<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To conclude we can say, both \u2018<strong>Remanufacturing\u2019 <\/strong>and <strong>\u2018Servicing\u2019 <\/strong>procedures ultimately aim to restore a medical device to its performance and safety standards specified by the authentic equipment manufacturer. There is a requirement of medical device regulation. The main goals of regulation are to prevent access to harmful products and to provide patients with high quality, safe &amp; sound and effective medical devices. The enactment of strict regulation ensures betterment and benefit to public health as well as security of patients, medical personnel, the general public and other communities, when it is properly applied.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>: <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/registration-process-for-medical-devices-in-india\/\">A Step By Step Guide For Registration Process For Medical Devices In India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As per the draft guidelines laid down by FDA (Food and Drugs Administration), \u201cRemanufacturing\u201d is defined as the process, conditions, refurbishes, replenishing, restoring or any other related act done towards the completion of final device that significantly changes the finished devices performance and conduct or safety specification on intended use. In order to help ensure [&hellip;]<\/p>\n","protected":false},"author":55,"featured_media":52624,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[3110],"acf":{"service_id":"385"},"authorName":"Soumyadipa Banik","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2023\/02\/MicrosoftTeams-image-66.jpg","authorDescription":"Soumyadipa is a legal professional and has completed her Masters (L.L.M.) in Business Law from Amity University. She is an aspiring content writer and legal researcher with more than a year experience. She have earlier worked for Startup companies and written business and legal articles, blogs and website content. She is good at presenting complex issues in organized, easy-to-understand terms and committed to provide highly persuasive content.","postViews":2410,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52623"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/55"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=52623"}],"version-history":[{"count":3,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52623\/revisions"}],"predecessor-version":[{"id":52627,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52623\/revisions\/52627"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/52624"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=52623"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=52623"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=52623"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}