Medical Device Inspection Laboratory Verlab, Sarajevo, Bosnia and Herzegovina.
Faculty of Pharmacy Sarajevo, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
Biomed Eng Online. 2020 Oct 2;19(1):75. doi: 10.1186/s12938-020-00820-0.
The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic.
The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented.
It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level.
Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.
世界正面临着由 COVID-19 大流行引起的前所未有的、影响人类生活方方面面的疫情爆发。由于该病毒具有新颖性，医疗系统面临着患者数量增加和医疗产品短缺的挑战。为了满足对基本医疗产品的需求增加，各国当局在全球范围内做出了各种立法让步。这导致汽车、纺织和其他行业的各种公司生产基本医疗产品，并在国家监管机构的紧急使用授权或法律特许下获得批准。本文对 COVID-19 大流行期间基本医疗产品的紧急使用授权和法律特许的现有文件进行了叙述性评论。
叙述性评论的基础包括在 Web of Science、Scopus、PubMed 和 Embase 数据库中发表的科学文章、国际组织的官方出版物：食品和药物管理局（FDA）、世界卫生组织（WHO）、世界银行和联合国（UN），以及 2019 年 11 月 1 日至 2020 年 5 月 1 日以母语（英语、德语、波斯尼亚语和克罗地亚语）出版的国家监管机构报告。本文重点关注三种基本医疗产品：机械呼吸机、个人防护设备（PPE）和诊断测试。对现有的数据和紧急使用授权和法律特许的潜在风险进行了循证评论。
人们认识到，现在比以往任何时候都更需要提高全球对尊重基本要求的重要性的认识和了解，以确保医疗产品的适当质量、性能和安全性，特别是在 COVID-19 大流行等疫情爆发期间。应严格规定和明确针对每一种情况下的医疗产品的生产、进口和批准的紧急使用授权，而不应将其普遍适用于所有医疗产品，因为所有医疗产品都与不同的风险水平相关。
所提出的考虑和经验应作为所有可能的未来疫情爆发情况的指南，以防止国家监管机构即兴反应。
