TY - JOUR
T1 - COVID-19: ensuring our medical equipment can meet the challenge
AU - Garzotto, Francesco
AU - Ceresola, Erica
AU - Panagiotakopoulou, Sofia
AU - Spina, Giovanni
AU - Menotto, Francesca
AU - Benozzi, Marco
AU - Casarotto, Maurizio
AU - Lanera, Corrado
AU - Bonavina, Maria Giuseppina
AU - Gregori, Dario
AU - Meneghesso, Gaudenzio
AU - Opocher, Giuseppe
N1 - Funding Information:
This paper was not funded. A special thanks to Nicola Cautadella?AOPD for his commitment during the coronavirus emergency and to the Hospital Biomedical Engineering Veneto HBE-V: Anna Gelisio, Azienda Zero, Laura Chiea?AULSS 1, Gaia Valentinis, Agnese Casarin, Antonio Lomoriello, Simone Fregolent?AULSS 2, Mria Antonietta Francesca, Alessandro Porcu, Mara Semenzato?AULSS3, Alan Petten? -AULSS 4, Michele Tenan AULSS 5, Paolo Colombi, Lorenzo Camiletti AULSS6, Paolo Zaltron ULSS 7, Bruno Sandini, Francesco Bellato, Roberto Artuso, Erica Ceresola?AULSS 8, Giacomo Pintani, Mario Brunelli AULSS 9, Davide Fasoli, Manuela Spano, Davide Perli?AOUIVR
COVID LINEA INDIPENDENTE
Publisher Copyright:
© 2020, © 2020 Informa UK Limited, trading as Taylor & Francis Group.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/6/2
Y1 - 2020/6/2
N2 - To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities with the required technology is a challenge. The availability of essential medical equipment to support patients affected by Covid-19 is globally limited. Areas covered: This perspective gives a technical view of the pandemic focusing on the main actions taken by regulatory agencies to cope with the shortage of devices. The risk/benefit assessment and the main infection control policies in the clinical practices are also looked at. Expert opinion: Regulatory agencies have amended their medical devices directives to address the pandemic, but each in a different way. In this exceptional situation scientist and technology experts in collaboration with medical specialists should work together to re-assess the risk analysis on medical equipment management and their use and re-use in this context with the aim to improve global health care Every effort must be made to provide the necessary devices at least with the minimum acceptable performances for Covid-19 patients while maintaining a high standard of safety for users. The aim of the present manuscript is to highlight the technical challenges in order to prevent, through targeted actions, operating standards from falling below the standards of care due to a lack of medical devices. Abbreviations: AKI: acute Kidney Injury; ARGMD: Australian Regulatory Guidelines for Medical Devices; Covid-19: Coronavirus disease; FDA: Food and Drug Administration; ECMO: Extracorporeal Membrane Oxygenation; EU: European Union; ICU: Intensive Care Unit; WHO: World Health Organization; MHRA: Medicines and Healthcare products Regulatory Agency; MDR: Medical Device Regulation; SARI: Severe Acute Respiratory Infection.
AB - To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities with the required technology is a challenge. The availability of essential medical equipment to support patients affected by Covid-19 is globally limited. Areas covered: This perspective gives a technical view of the pandemic focusing on the main actions taken by regulatory agencies to cope with the shortage of devices. The risk/benefit assessment and the main infection control policies in the clinical practices are also looked at. Expert opinion: Regulatory agencies have amended their medical devices directives to address the pandemic, but each in a different way. In this exceptional situation scientist and technology experts in collaboration with medical specialists should work together to re-assess the risk analysis on medical equipment management and their use and re-use in this context with the aim to improve global health care Every effort must be made to provide the necessary devices at least with the minimum acceptable performances for Covid-19 patients while maintaining a high standard of safety for users. The aim of the present manuscript is to highlight the technical challenges in order to prevent, through targeted actions, operating standards from falling below the standards of care due to a lack of medical devices. Abbreviations: AKI: acute Kidney Injury; ARGMD: Australian Regulatory Guidelines for Medical Devices; Covid-19: Coronavirus disease; FDA: Food and Drug Administration; ECMO: Extracorporeal Membrane Oxygenation; EU: European Union; ICU: Intensive Care Unit; WHO: World Health Organization; MHRA: Medicines and Healthcare products Regulatory Agency; MDR: Medical Device Regulation; SARI: Severe Acute Respiratory Infection.
KW - Covid-19
KW - equipments
KW - healthcare
KW - medical devices
KW - regulatory
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U2 - 10.1080/17434440.2020.1772757
DO - 10.1080/17434440.2020.1772757
M3 - Article
C2 - 32434400
AN - SCOPUS:85086792738
VL - 17
SP - 483
EP - 489
JO - Expert Review of Medical Devices
JF - Expert Review of Medical Devices
SN - 1743-4440
IS - 6
ER -