Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study

BioMedical Engineering OnLine

Fahir Bečić¹  Zijad Džemić²  Almir Badnjević³  Lejla Gurbeta Pokvić⁴ 

[1] Faculty of Pharmacy Sarajevo, University of Sarajevo, Sarajevo, Bosnia and Herzegovina;Institute of Metrology of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina;Medical Device Inspection Laboratory Verlab, Sarajevo, Bosnia and Herzegovina;Faculty of Pharmacy Sarajevo, University of Sarajevo, Sarajevo, Bosnia and Herzegovina;International Burch University, Sarajevo, Bosnia and Herzegovina;Medical Device Inspection Laboratory Verlab, Sarajevo, Bosnia and Herzegovina;International Burch University, Sarajevo, Bosnia and Herzegovina;

关键词: Medical device;    Outbreak;    COVID-19;    Regulatory framework;    Import;    Market placement;   

DOI  :  10.1186/s12938-020-00820-0

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodologyThe 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.DiscussionIt 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.ConclusionPresented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.

【 授权许可】

CC BY