• Francesco Garzotto, Erica Ceresola, Sofia Panagiotakopoulou, Giovanni Spina, Francesca Menotto, Marco Benozzi, Maurizio Casarotto, Corrado Lanera, Maria Giuseppina Bonavina, Dario Gregori, Gaudenzio Meneghesso, and Giuseppe Opocher.
• Healthcare Directorate Unit, Veneto Institute of Oncology IRCCS , Padova, Italy.
• Expert Rev Med Devices. 2020 Jun 1; 17 (6): 483-489.

AbstractTo 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.

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