- 學位論文
以U.S. FDA 21 CFR 820 Sec.820.30 Design Controls 探討呼吸器的研發流程
The Design Process of Ventilator in accordance with U.S. FDA 21 CFR 820 Sec.820.30 Design Controls
摘要
摘要 隨著2019年12月份開始，COVID-19的疫情在全球急速的擴散，世界各國紛紛宣佈進入國家緊急狀態。世界衛生組織（WHO）在2020年1月30日，正式宣布此新冠肺炎為國際性的公共衛生緊急事件，3月11日，宣布新冠肺炎為大流行（Pandemic）。同年3月13日，美國疫情大爆發，美國總統唐納．川普宣布美國進入國家緊急狀態。截至2021年5月28日，全球總死亡人數超過350萬人，確診人數超過2億3仟萬人。 在全球疫情如此嚴峻的情形下，世界各國的呼吸器也呈現了嚴重不足的情況。所幸呼吸器大廠 Medtronic 在2020年3月，在他們公司的官網上, 公開分享了他們的醫療用呼吸器 Puritan Bennett™ 560 (PB560) portable ventilator，簡稱PB560的產品技術文件。六大套系統的文件，內容主要包括了：產品使用手冊、產品設計檔案、生產製造文件、產品規格書、零件規格表、3D CAD 檔案以及HEX軟體原始碼等一系列的技術文件。 Medtronic 於其網站說明，公開此份文件的主要目的是希望能協助有興趣參與呼吸器製造的廠商縮短其研發及法規審查的時程。但以Medtronic 所分享的六大套系統文件，如若是要依 21 CFR 820 Design Controls 的流程區分並以此申請相關之許可證，因其文件量龐大，要補足技術文件不足之處，實屬挑戰。 因此，此篇論文主要是以自身國內外認證申請之經驗，主要依 U.S. 21 CFR 820 Design Controls以及 U.S. FDA Design Control Guidance之要求，並同時參考 ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes 等法規及國際標準的要求，將Medtronic PB 560文件依照法規所要求的研發流程及順序，列出其技術文件的差異性。此外，在此份論文當中，也特別參照PB560的文件，列出與呼吸器相關的區域性法規以及應參照的國際標準，也可節省在申請產品認證的流程當中，再去尋找產品的符合性的標準，可避免誤用其他不適用的國際標準。 依照上述的分析比對，醫療器材製造商可參照技術文件的比對表，配合醫療器材設計開發流程的規範及要求，可加速整合並產出新一代呼吸器的技術文件，以符合產品於申請認證時，須提交完整的技術文件的要求。
並列摘要
Abstract In December 2019, the COVID-19 has spread rapidly around the world, and a log of countries around the world have announces a state of emergency. The World Health Organization (WHO) officially declared that the outbreak constitutes a Public Health Emergency of International Concern(PHEIC) on January 30, 2020. On March 11, WHO announces COVID-19 outbreak a Pandemic. On March 13th, the United States. President Donald John Trump have declared the United States into a state of national emergency. As of May 28, 2021, the total number of deaths worldwide has exceeded 3.5 million, and the number of confirmed cases has exceeded 230 million. In such a severe situation of the global pandemic, the ventilators of all countries in the world are facing seriously shortage. Fortunately, Medtronic, a global medical device manufacturer, publicly shared the technical documents of their medical ventilator Puritan Bennett™ 560 (PB560) portable ventilator, referred to as PB560, on their company's official website in March 2020. The documents contain the six major files on their website, mainly a series of technical documents, such as product manuals, product drawings, manufacturing documents, product specifications, specification sheets of parts, 3D CAD files, and HEX software source codes. Medtronic stated on its website that the main purpose of publishing those technical document is to help manufacturers who are interested in participating to manufacture the respirators to shorten the timeline for their research and development and regulatory review. However, based on the six sets of documents, it is a challenge to apply the either registration or certificate in accordance with U.S. FDA 21 CFR 820. Therefore, this thesis is based on my own with more than 7 years working experience in medical device industry as a Regulatory Affairs. In accordance with the requirements of US 21 CFR 820 Design Controls and US FDA Design Control Guidance, also refers to ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory Purposes and other regulations and international standards, the Medtronic PB 560 files are compared with the research and development process requirements, and the differences of the technical files are listed for further references. In addition, the regional regulations and international standards of the respirators are listed and should be referred to. With listed international standards, the process of applying for product certification could be easier and more efficiency. The listed standards can also avoid the misuse of other inapplicable international standards. Medical device manufacturers can refer to the comparison table and charts for the technical documents, and cooperate with the specifications and requirements of the medical device design and development process, which can accelerate the integration and output of the technical documents of the new generation of respirators to meet the requirements of product registration. To fulfilled the regulation requirements, a complete technical file must be submitted by medical device manufacturer.