ArticleBiomedical engineering online2020
Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study.
Article in Biomedical engineering online, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Study on the therapeutic effects and prognosis evaluation of non-invasive ventilation in patients with chronic obstructive pulmonary disease with lung cancer.Technology and health care : official journal of the European Society for Engineering and Medicine · 2024Article
- The Association between COVID-19 Related Anxiety, Stress, Depression, Temporomandibular Disorders, and Headaches from Childhood to Adulthood: A Systematic Review.Brain sciences · 2023Review
- The Role of Social Media in Communication and Learning at the Time of COVID-19 Lockdown-An Online Survey.Dentistry journal · 2023Article
- Survivability, resilience and sustainability of supply chains: The COVID-19 pandemic.Journal of cleaner production · 2022Article
- Performance Evaluation of Lateral Flow Assays for Coronavirus Disease-19 Serology.Clinics in laboratory medicine · 2022Review
- Cost-effective vital signs monitoring system for COVID-19 patients in smart hospital.Health and technology · 2022Article
- Is It Time to Call 'Code Blue' on Nursing Infrastructure? A Nurse's Perspective from the COVID-19 Front-line.Cardiac failure review · 2022Review
- Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.BMC infectious diseases · 2021Article
- The ethics of shared Covid-19 risks: an epistemological framework for ethical health technology assessment of risk in vaccine supply chain infrastructures.Health and technology · 2021Article
- Telemedicine and e-Health research solutions in literature for combatting COVID-19: a systematic review.Health and technology · 2021Review
- Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator.Open respiratory archivesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. METHODOLOGY: 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. DISCUSSION: 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.
conclusionPresented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.