COVID-19: ensuring our medical equipment can meet the challenge

ABSTRACT

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

KEYWORDS:

• Covid-19
• medical devices
• equipments
• regulatory
• healthcare

Article highlights

• Predict the global spread of coronavirus disease and consequently prepare the hospital facilities with the required technology is a challenge

• Covid-19 patients require a fully equipped ICU facilities with mechanical ventilation devices and accessories, monitoring systems, infusion pumps for nutrition and drugs/fluids delivery. Less severe patients mainly require high flow nasal cannula, Continuous Positive Airway Pressure ventilation/noninvasive ventilation and monitoring.

• Local resources and constraints will impact how the provision of the above equipments can best be implemented

• The availability of essential medical equipments to support patients affected by Covid-19 is globally limited and the regulatory agencies have acted differently

• Scientist and technology experts in collaboration with medical specialists should work together to re-assess the risks analysis on medical equipment management in order to facilitate the local health-care institutions

Acknowledgments

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 Pettenà -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

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributions

Paper conception: F Garzotto; providing intellectual content: F Garzotto, E Ceresola, G Meneghesso, G Opocher; data analysis: D Gregori, C Lanera, S Panagiotakopoulou, E Ceresola, F Menotto, M Casarotto; paper final approval: MG Bonavina, G Meneghesso, G Opocher; Paper draft: F Garazotto, E Ceresola, M Benozzi, C Lanera; revising paper: S Panagiotakopoulou, G Spina, MG Bonavina; literature investigation: S Panagiotakopoulou, M Benozzi, F Menotto, M Casarotto; Supervision: MG Bonavina, G Spina, D Gregori.

Availability of data and materials

Data on Covid-19 are available here: https://r-ubesp.dctv.unipd.it/shiny/covid19ita/

Additional information

Funding

This paper was not funded.