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10.1186/s12938-020-00820-0 http://scihub22266oqcxt.onion/10.1186/s12938-020-00820-0 33008462!7530883!33008462     free     free     free Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 245.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Biomed+Eng+Online 2020 ; 19 (1): 75 Nephropedia Template TP {{tp|p=33008462|t=2020. Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study |pdf=|usr=}}{{33008462}} gab.com Text Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study JO: Biomed Eng Online http://www.kidney.de/pget.php?&tw=1&pmid=33008462 #FOAvip BACKGROUND: 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. 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. CONCLUSION: Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies. Twit Text FOAVip Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study ????Biomed Eng Online http://www.kidney.de/pget.php?&tw=1&pmid=33008462 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33008462 #FOAvip English Wikipedia <ref>{{Cite pmid|33008462}}</ref> Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study #MMPMID33008462 Badnjevic A; Pokvic LG; Dzemic Z; Becic F Biomed Eng Online 2020[Oct]; 19 (1): 75 PMID33008462show ga BACKGROUND: 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. 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. CONCLUSION: Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies. |*Betacoronavirus[MESH] |*Coronavirus Infections/diagnosis[MESH] |*Pandemics[MESH] |*Pneumonia, Viral[MESH] |COVID-19[MESH] |COVID-19 Testing[MESH] |Clinical Laboratory Techniques/standards[MESH] |Commerce/*legislation & jurisprudence[MESH] |Equipment Failure[MESH] |European Union[MESH] |Global Health[MESH] |Humans[MESH] |Licensure/*legislation & jurisprudence[MESH] |Manufacturing Industry/*legislation & jurisprudence[MESH] |Personal Protective Equipment/standards/*supply & distribution[MESH] |Reagent Kits, Diagnostic/standards/*supply & distribution[MESH] |Risk Assessment[MESH] |SARS-CoV-2[MESH] |United States[MESH] |United States Food and Drug Administration[MESH]Risks of emergency use authorizations for medical products during outb(epmc).pdf DeepDyve Pubget Overpricing