Expert Review of Medical Devices

ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/ierd20

COVID-19: ensuring our medical equipment can

meet the challenge

Francesco Garzotto , Erica Ceresola , Sofia Panagiotakopoulou , Giovanni

Spina , Francesca Menotto , Marco Benozzi , Maurizio Casarotto ,
Corrado Lanera , Maria Giuseppina Bonavina , Dario Gregori , Gaudenzio
Meneghesso & Giuseppe Opocher

To cite this article: Francesco Garzotto , Erica Ceresola , Sofia Panagiotakopoulou , Giovanni
Spina , Francesca Menotto , Marco Benozzi , Maurizio Casarotto , Corrado Lanera , Maria
Giuseppina Bonavina , Dario Gregori , Gaudenzio Meneghesso & Giuseppe Opocher (2020)
COVID-19: ensuring our medical equipment can meet the challenge, Expert Review of Medical
Devices, 17:6, 483-489, DOI: 10.1080/17434440.2020.1772757

To link to this article: https://doi.org/10.1080/17434440.2020.1772757

Accepted author version posted online: 21

May 2020.
Published online: 13 Jun 2020.

Submit your article to this journal

Article views: 799

View related articles

View Crossmark data

Full Terms & Conditions of access and use can be found at

https://www.tandfonline.com/action/journalInformation?journalCode=ierd20
EXPERT REVIEW OF MEDICAL DEVICES
2020, VOL. 17, NO. 6, 483–489
https://doi.org/10.1080/17434440.2020.1772757

SPECIAL REPORT

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

Francesco Garzottoa,b, Erica Ceresolac, Sofia Panagiotakopouloud, Giovanni Spinae, Francesca Menottof,
Marco Benozzig, Maurizio Casarottoh, Corrado Lanerab, Maria Giuseppina Bonavinaa, Dario Gregorib,
Gaudenzio Meneghessoi and Giuseppe Opocherj
a
Healthcare Directorate Unit, Veneto Institute of Oncology IRCCS, Padova, Italy; bDepartment of Cardiac Thoracic Vascular Sciences and Public
Health, Unit of Biostatistics, Epidemiology and Public Health, University of Padova, Padova, Italy; cBioengineering Department, AULSS 8 Berica, San
Bortolo Hospital. Vicenza, Italy; dBioengineering Department, Veneto Institute of Oncology IRCCS,Padova, Italy; eTechnical Department, Padua
University Hospital, Padova, Italy; fTechnical Department, Tenders and Contracts Unit, Padua University Hospital, Padova, Italy; gTechnical
Department, Bioengineering Unit, Padua University Hospital, Padova, Italy; hBioengineering Department, AULSS 7 San Bassiano Hospital, Bassano
del Grappa, Italy; iDepartment of Information Engineering, University of Padova. Padova, Italy; jScientific Directorate, Veneto Institute of Oncology
IRCCS, Padova, Italy

ABSTRACT ARTICLE HISTORY

To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities Received 7 April 2020
with the required technology is a challenge. The availability of essential medical equipment to support Accepted 19 May 2020
patients affected by Covid-19 is globally limited. KEYWORDS
Areas covered: This perspective gives a technical view of the pandemic focusing on the main actions Covid-19; medical devices;
taken by regulatory agencies to cope with the shortage of devices. The risk/benefit assessment and the equipments; regulatory;
main infection control policies in the clinical practices are also looked at. healthcare
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

1. Introduction spreads observed in three lockdowned regions. The Italian trend

To predict the global spread of coronavirus disease and conse­ observed at a regional level can be an interesting model that
quently prepare the hospital facilities with the required technol­ highlights the difficulties of predicting the extent of the disease
ogy is a challenge motivated by many cultural, socio-economic, and, above all, the number of hospitalized patients. The National
and political grounds. Forecasts are currently mainly based on healthcare system in Italy transfer to a regional level a significant
observed trends in China, South Korea, and Italy where different autonomy in determining the macro structure of their health
levels of restrictions have been taken. Moreover, the average age organization. We briefly analyzed the trend of the available data
in China is of 8 years lower than in Italy (37 vs 45.9 years) (similar regarding the hospitals and intensive care units (ICUs) admission
situation in other European countries) and the over 65 are 10% and the proportion of patients who needed an intensive care
less (respectively, 12.6% vs 22.8%). The higher number of comor­ support in these regions. Clinical indications and medical equip­
bidities and the fragility of elderly patients may have a relevant ments required to treat these patients are reported focusing on
impact on the proportion of patients who need healthcare sup­ technical and safety notes. Actions taken by regulatory agencies
port and on mortality [1]. It could, almost in part, explain the to address the emergency and the main challenges to be faced
higher proportion of patients admitted in the Intensive Care Unit have discussed based on our experience. The aim of the present
(ICU) in Italy, >10% [2] comparing to China, 5%. The planning of is to highlight the technical challenges, that will be widely
new facilities for the coronavirus disease (Covid-19) patients in addressed to policy makers and health-care institutions, in
Europe and other countries should carefully consider the data order to prevent, through targeted actions, operating standards
that are emerging from Italy and particularly on the different from falling below normal standards of care [3].

CONTACT Francesco Garzotto francesco.garzotto@iov.veneto.it Healthcare Directorate Unit, Veneto Institute of Oncology IRCCS, Padova, Italy Via
Gattamelata, 64 Padova. Italy
© 2020 Informa UK Limited, trading as Taylor & Francis Group
484 F. GARZOTTO ET AL.

2. Health care intensive care unit load

As describe by Grasselli [4] a positive patient was firstly found
on 20 February in Codogno, Lombardia Region (LR) (10 mil­
lion inhabitants), Italy: a cluster of unknown magnitude was
present and additional spread was likely based on the
assumption that secondary transmission was already occur­
ring, a containment was provided in the area. Similarly, in the
Veneto Region (VR) (5 million inhabitants) were the same
were imposed severe measures of containment were progres­
sively expanded due to further cluster identified also in Emilia
Romagna, enforcing social distancing for the entire popula­
tion, isolation of all positive cases, forcing quarantines of
entire households close to anyone with positive swab, and
closing all schools and universities. Further containment mea­
sures have been issued up to a decree to lock down the
whole country on 10 March. The up-mentioned regions are
bordering, notwithstanding they have implemented the same
containment policies, at the same time, they have a comple­
tely different virus spread and hospitalized patients as fea­
tured by Figure 1 [5]. So far any attempt to justify a such a
discrepancy turned out to be unfounded and any model that
tried to fit both trends (mainly Veneto and Emilia vs
Lombardia) has failed. With the current knowledge of the
disease, a model that can be universally validated seems to
be unavailable. It should be at least, but not only, adjusted
considering the initial spread (outbreaks), the containment
policy, the containment strategy (e.g., laboratory tests per
thousand inhabitant), the protective measures, the popula­
tion demographic and probably also the density of inhabi­
tants per square meter (magnitude of the metropolitan area).
Moreover the expected efficacy of other mitigation efforts
taken to slowdown the virus spread are noticeable in ICU
several days after their implementation [1]. There is currently
no standard of care for these patients, several clinical trials
are ongoing, health-care resources are limited and ICU length
of stay may differ considerably. Nevertheless, the proportion
of hospitalized patients who have required an intensive care
unit (ICU) support on the above regions is relatively stable
(Average-Maximum: LR:13%-18%, ER: 12%-13.5%, and VR:
22.5%-25%, Figure 2). Modeling the number of hospitalized
patients can be a reliable strategy to predict the real load on
hospital facilities. The data monitoring from our group
in Padova (https://r-ubesp.dctv.unipd.it/shiny/covid19italy/)
showed several signs that the overall efforts of the Veneto
Region are actually proving their effectiveness in slowing
down the outbreak, with a significant number of inpatients
and people in intensive care avoided during the first week of
the epidemic. From the above-reported data on the magni­
tude on ICU admissions, some facilities will face with an
enormous demand of medical devices to meet the patient
Figure 1. Time series of: Covid-19 positive-detected patients, hospitalized
care needs. In Europe the sub-regions of Italy, France, the patients, quarantine patients, and admitted to ICU patients for Veneto,
Netherlands and Spain have already reported healthcare sys­ Lombardia, and Emilia Romagna regions – Italy. Figure is from Covid19ita
tem saturation due to very high patient loads requiring inten­ project available at https://r-ubesp.dctv.unipd.it/shiny/covid19ita/ [5]. Data are
disseminated by the Presidenza del Consiglio dei Ministri – Dipartimento di
sive care [6]. Protezione Civile delivered by the Minister of Health.
 EXPERT REVIEW OF MEDICAL DEVICES 485

Figure 2. Proportion of Covid-19 hospitalized patients admitted to ICU. Data are calculated from Covid19ita project available at https://r-besp.dctv.unipd.it/shiny/
covid19ita/. The proportion is calculated by the daily-hospitalized patients and daily ICU’s patients ratio and are not based on patients' clinical history.

3. Patient care, medical equipments dedicate equipment are also necessary and should be pro­
vided to the respiratory, infectious disease or COVID-19 dedi­
The Clinical management of severe acute respiratory infection
cated units.
for coronavirus patients published by the World Health
Organization (WHO) [7] give some technical address alongside
clinical ones: for patients admitted to hospital with severe
4. Regulatory actions and risk/benefit assessment
acute respiratory infection (SARI) and respiratory distress,
hypoxemia or shock and target SpO2 > 94%, it is recom­ Local resources and constraints will impact how the provision
mended to provide supplemental oxygen therapy immedi­ of the above equipments can best be implemented, always
ately; ‘all areas where patients with SARI are cared for should fulfilling with the care standards. Medical devices regulatory,
be equipped with pulse oximeters, functioning oxygen sys­ the CE Mark in the European Union (EU), the Food and Drug
tems and disposable, single-use, oxygen-delivering interfaces Administration FDA-approval in the United States (US), the
(nasal cannula, nasal prongs, simple face mask, and mask with Australian Regulatory Guidelines for Medical Devices
reservoir bag).’ In the most severe cases, COVID-19 can be (ARGMD), and other similar procedures for other countries,
complicated by acute respiratory disease syndrome (ARDS), essentially performs the same functions assessing the safety
sepsis, and septic shock, multiorgan failure, including acute and efficacy of devices. The ‘general safety and performance
kidney injury (AKI), and cardiac injury [7]. These patients requirements’ of the European Medical Device Regulation
require a fully equipped ICU facilities with mechanical ventila­ (MDR) [14] (postponed to May 2021), defined on Annex I, is
tion devices and accessories, monitoring systems, infusion extremely clear and can be used as reference: devices ‘shall be
pumps for nutrition and drugs/fluids delivery. A comprehen­ safe and effective and shall not compromise the clinical con­
sive list of medical devices for Covid-19 and related standards dition or the safety of patients, or the safety and health of
is available on the WHO disease commodity package [8]. users … ’ and” … any risks which may be associated with their
Furthermore, Renal Replacement Therapy (RRT) system to use constitute acceptable risks when weighed against the
treat AKI and Fluid Overload (FO) [9] and Extracorporeal mem­ benefits to the patient …” this in the contest of ‘the generally
brane oxygenation (ECMO) are also devices to consider [10]. In acknowledged state of the art.’ To provide these evidences the
a retrospective study [11] 59% of the cases developed SEPSI, benefit-risk determination is required. It is based on the deter­
15% AKI, and 5% were treated with RRT. Studies specifically mination of ‘all assessments of benefit and risk of possible
focused on CRRT as supportive therapies for the Covid-19- relevance for the use of the device …’ where risk is defined in
septic patients are currently lack but treatments and devices MDR-Article 2 as the ‘combination of the probability of occur­
aimed to reduce the cytokine storm associated with the Covid- rence of harm and the severity of that harm.’ All the above-
19 [12] have been extensively reported [13]. For less severe mentioned regulatory programs are risk-based and are nor­
patients high flow nasal cannula, Continuous Positive Airway mally evaluated in routine patient care. The current demand
Pressure/noninvasive ventilation (CPAP/NIV), monitors and for medical facilities, particularly for those related to the ICUs,
486 F. GARZOTTO ET AL.

exceeds the local availability with potential serious conse­ highlight the challenge health-care institutions and hospitals
quence on patients care. Benefits, which includes the impact face with, when evaluating the infection control policies and
on patient health, quality of life and on survival, and the risks practices related to the medical equipment use, we summarize
(no further available therapies) are assessed differently in such the most common issues. Firstly, an adequate training to
context. In this perspective, the regulatory agencies have personnel and appropriate protocols are mandatory to pre­
acted differently. The Food and Drug Administration (FDA) vent hospitals became the main Covid-19 carriers [3].A strat­
allow medical device makers to more easily make changes to egy for selecting the devices for COVID-19 patients, especially
existing products, such as changes to suppliers or materials for ventilators (intensive care, transportable, anesthesia) has to
[15]. Furthermore, to permit for the emergency use in health- be implemented, including the training for the new ones. To
care settings of certain ventilators, anesthesia gas machines mitigate the high demand for ventilators, one strategy that
modified for use as ventilators, and positive pressure breath­ hospitals can use, is to split the ventilator to serve two
ing devices, FDA issued an Emergency Use Authorization patients. We have several concerns about this technique, but
(EUA) [16].In particular the use of a ventilator for multiple it is allowed in some countries and goes beyond the purposes
patients simultaneously, has been made possible utilizing of our analysis. To reduce the risk of spreading the disease,
dedicated ventilator tubing connectors. A guideline on how filters on the exhalation limb of ventilator circuits can be
to utilize anesthesia ventilators, normally not labeled for long- placed, but devices performance must be often evaluated. A
term ventilatory support, has been provided by the American decrease on efficiency can in fact occur. Breathing circuits, and
Society of Anesthesiologists and Anesthesia Patient safety any other devices that are exposed to the patient’s oral secre­
foundation [17]. Health Canada also look to approvals granted tions are also potential sources of contaminations. When a
by others regulatory authorities in deciding whether to ventilator is used in a hazardous environment, it is recom­
approve an application for the importation or sale of COVID- mended that gas delivered to the patient comes from either
19-related medical devices. Intended use of existing devices, a pressurized medical-grade oxygen source and/or filtered
not originally COVID-19-related, could also be expanded under ambient air passed through the Fresh Gas/Emergency Air
this Interim Order. The United Kingdom (UK) Medicines and Intake (or through the Fresh Gas Air inlet using an appropriate
Healthcare products Regulatory Agency MHRA authorize filter). A reduction in the workload for the management of the
industries to supply a non-CE marked device in the interest device is mandatory. RRT can be performed utilizing regional
of the protection of health [18] establishing a fast-track citrate anticoagulation: circuit life span is higher and technical
approval of medical devices during COVID-19 outbreak. downtimes due to central venous catheter malfunction or
Furthermore, specification for ventilators to be used in UK circuit/filter coagulation are avoided [22]. The more easier
hospitals during the coronavirus (COVID-19) outbreak has and effective protocol for device disinfection should be
been issued [19], promoting and boosting the manufacturers adopted. The reutilization of a device, even not envisaged by
on further developments. The European commission provides the manufacturer, can be considered reevaluating the benefit/
a guideline on Medical Device requirements [20]. An interest risk ratio. According to the degree of risk of infection asso­
Annex on the standards to comply with, under various juris­ ciated with the use of the device they are categorized in three
dictions of the International Medical Device Regulators Forum, classes by the FDA. In Europe, the MDR defines a new reusa­
highlight how a global harmonization is hard. The common ble/reprocessed class I devices (Ir) where safety and efficacy of
effect of these initiatives is to increase the availability of the the cleaning, disinfection, and sterilization processes have to
devices in the respective countries, but without a coordination be supported by the manufacturer. An extreme example is the
between them. The creation of regional and international net­ case of helmets for noninvasive ventilation that may delay or
works allows the timely distribution of devices where they are prevent the need of an endotracheal intubation [23] in the
more needed. Moreover, hospitals and stockholders must be contest of limited availability of devices. Manufacturers, under
prepared to utilize anesthesia units for ICU ventilation, within particular circumstance, may try to provide actions aimed to
the required sources and supplies. Actions aimed at facilitating mitigate (not eliminate) the risk of cross-contamination when
and standardizing device management and resources optimi­ reutilized. Hospital institutions, involving the risk prevention
zation at the hospital level, as WHO has done for patients [7], unit, may also evaluate their re-use. Generalizing, when the
has not yet been widely implemented. The involvement of destination use and the utilization, differs from those provided
repurposed hospital staff to manage and support ICU physi­ by the manufacturers, a minimally acceptable performance
cians may strongly take advantage on a such documentation. must be guarantee in order to ensure an adequate clinical
Some exceptions on actions aimed to support the workload benefit and prevent increased harms. In this exceptional situa­
during a crisis are those done by the FDA in attempt to tion scientist and technology experts in collaboration with
minimize the risk of exposure to coronavirus, reconsidering medical specialists should work together to re-assess the
the benefit/risk for the remote control systems (noninvasive, risks analysis [24] on medical equipment management and
vital sign-measuring devices). Extending, temporary, their use to search for the most appropriate solutions globally.
so that health-care providers can use them to monitor patients Demand to local institutions these responsibilities may impact
remotely [21], the need for hospital visits are reduced and the on patient safety as the case of extension tubing applied to
risk of exposure to coronavirus minimized. With the aim to extracorporeal treatments [25]. Procedure and adequate
 EXPERT REVIEW OF MEDICAL DEVICES 487

training to all health-care workers should be provided in order challenge. Demand mitigation can currently only occur when
to prevent cross-contaminations and safety. Figure 3 sum­ early and appropriate virus containment measures are pro­
marizes the information flows. vided, followed by a rapid and effective response in handling
positive cases.

5. Conclusions
6. Expert opinion
The availability of essential medical equipments to support
patients affected by Covid-19 is globally limited. Our data on Clinical management of Covid-19 patients has been promptly
the ICUs load confirms the enormous pressure they will be updated by WHO following the most recent evidences.
under. Our review on the measures taken by countries to Medical devices, in absence of a dedicated medical therapy,
address this criticality, highlights the limited availability of are in the forefront of supporting critically ill patients. Health-
dedicated actions. Furthermore, there is no link between care institutions would benefit from guidance on how to make
them, discouraging a wide action. A globally harmonized the best use of hospital technology and resources. Several
regulation for the most useful medical devices for coronavirus efforts by national health-care institutions are providing
patients can standardize their production and thus ensure actions and guidance on possible solutions to meet the
compliance with all national legislation. Furthermore, a guide­ increased demand of medical equipment. A coordination
line on how to handle medical equipments under the Covid- may improve global knowledge optimizing strategic
19 emergency, as done by WHO for the management of resources. Regulatory agencies should also try to define a
patients, is of upmost necessary, leaving room for dangerous shared documentation on the minimum standard of perfor­
actions. In this exceptional situation scientist and technology mance and essential requirements to treat patients with
experts in collaboration with medical specialists should work Covid-19 facilitating and stimulating manufactures in invest­
together to re-assess the risks analysis [24] on medical equip­ ments and new production. Standard procedure based on a
ment management and their use (and re-use) in a biohazard revisited risk/benefit analysis contextualized to the current
context with the aim to improve the global health care Every crisis may also be appreciated by several health-care institu­
effort must be made to provide the necessary devices at least tion who daily face with these multidisciplinary activities.
with the minimum acceptable performances for Covid-19 In 5 years, the complex world of medical devices will harmo­
patients while maintaining a high standard of safety for nize the different approaches in the evaluation of the existing
users. Predicting when and where exactly to allocate these and new technologies. The new European Directive on MDR
resources with the current knowledge of the disease is a medical devices will further coordinate the efforts of national

Figure 3. Information flows during the COVID-19 pandemic. Local institutions provide technical protocols and rules starting from country regulations (regulatory
agencies). A risk assessment and prevention unit prepare protocols according to institutional skills. Clinical management derives from countries health systems and
are often harmonized whit those shared by the World Health Organization.
488 F. GARZOTTO ET AL.

manufacturers and health institutions in the regulatory process, crises in Italy: changing perspectives on preparation and mitiga­
which is strongly focused on producing clinical evidence. From tion. NEJM Cat Innovations Care Delivery. 2020;1:2.
4. Grasselli G, Pesenti A, Cecconi M. Critical care utilization for the
the other side, hospitals and clinicians should be ready to give
COVID-19 outbreak in Lombardy, Italy: early experience and fore­
adequate support with the common aim to improve global cast during an emergency response. JAMA. 2020;323(16):1545.
health. In this context, the lessons from national health institu­ 5. al. DGe: covid19ita; 2020 Mar [cited 2020 Mar 24]. https://r-ubesp.
tions in the management of medical equipment in the Covid-19 dctv.unipd.it/shiny/covid19ita/(Last
crisis must be exploited and further strengthened by establish­ 6. European Centre for Disease Prevention and Control. Risk assess­
ment on COVID-19; 2020 March 25 [cited Mar 26]. https://www.
ing a network of national health institutions.
ecdc.europa.eu/en/current-risk-assessment-novel-coronavirus-
situation.
7. WorlHealtOrganization: clinical management of severe acute
Acknowledgments respiratory infection (SARI) when COVID-19 disease is suspected;
A special thanks to Nicola Cautadella – AOPD for his commitment during 2020 [cited 2020 Mar 23.
the coronavirus emergency and to the Hospital Biomedical Engineering 8. Organization WH: disease commodity package - Novel Coronavirus
Veneto HBE-V: Anna Gelisio, Azienda Zero, Laura Chiea – AULSS 1, Gaia (COVID-19); 2020 Mar [cited 2020 Mar 25]. https://www.who.int/
Valentinis, Agnese Casarin, Antonio Lomoriello, Simone Fregolent – AULSS publications-detail/disease-commodity-package—novel-corona
2, Mria Antonietta Francesca, Alessandro Porcu, Mara Semenzato – virus-(ncov)
AULSS3, Alan Pettenà -AULSS 4, Michele Tenan AULSS 5, Paolo Colombi, 9. Garzotto F, Ostermann M, Martin-Langerwerf D, et al. The dose
Lorenzo Camiletti AULSS6, Paolo Zaltron ULSS 7, Bruno Sandini, Francesco response multicentre investigation on fluid assessment
Bellato, Roberto Artuso, Erica Ceresola – AULSS 8, Giacomo Pintani, Mario (DoReMIFA) in critically ill patients. Crit Care. 2016;20(1):196.
Brunelli AULSS 9, Davide Fasoli, Manuela Spano, Davide Perli – AOUIVR 10. Bouadma L, Lescure FX, Lucet JC, et al. Severe SARS-CoV-2 infec­
tions: practical considerations and management strategy for inten­
sivists. Intensive Care Med. 2020;46:579–582.
11. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for
Funding
mortality of adult inpatients with COVID-19 in Wuhan, China: a
This paper was not funded. retrospective cohort study. Lancet. 2020;395(10229):1054–1062.
12. Huang C, Wang Y, Li X, et al. Clinical features of patients infected
with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395
Declaration of interest (10223):497–506.
13. Ankawi G, Neri M, Zhang J, et al. Extracorporeal techniques for the
The authors have no relevant affiliations or financial involvement with any treatment of critically ill patients with sepsis beyond conventional
organization or entity with a financial interest in or financial conflict with blood purification therapy: the promises and the pitfalls. Crit Care.
the subject matter or materials discussed in the manuscript. This includes 2018;22(1):262.
employment, consultancies, honoraria, stock ownership or options, expert 14. TheEuropeanParliament-and-the-Council-of-the-EuropeanUnion:
testimony, grants or patents received or pending, or royalties. EU directive 2017/745; 2020 [cited 2020 Mar 23]. https://eur-lex.
europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
15. FoodAndDrugAdministration: enforcement policy for ventilators
Reviewer disclosures and accessories and other respiratory devices during the corona­
virus disease 2019 (COVID-19) public health emergency; 2020 Mar
Peer reviewers on this manuscript have no relevant financial or other
[cited 2020 Mar 25]. https://www.fda.gov/media/136318/download
relationships to disclose.
16. Administration FaD: coronavirus disease 2019 (COVID-19) emer­
gency use authorizations for medical devices; 2020 Mar [cited Mar
31]. https://www.fda.gov/medical-devices/emergency-situations-
Authors’ contributions medical-devices/emergency-use-authorizations#covid19ventilators.
Paper conception: F Garzotto; providing intellectual content: F Garzotto, E 17. foundation ASoAaAPs: APSF/ASA guidance on purposing anesthe­
Ceresola, G Meneghesso, G Opocher; data analysis: D Gregori, C Lanera, S sia machines as ICU ventilators; 2020 Mar. [cited 2020 Mar 25].
Panagiotakopoulou, E Ceresola, F Menotto, M Casarotto; paper final https://www.asahq.org/in-the-spotlight/coronavirus-covid-19-infor
approval: MG Bonavina, G Meneghesso, G Opocher; Paper draft: F mation/purposing-anesthesia-machines-for-ventilators.
Garazotto, E Ceresola, M Benozzi, C Lanera; revising paper: S 18. Medicines-and-healthcare-products-regulatory-agency-MHRA:
Panagiotakopoulou, G Spina, MG Bonavina; literature investigation: S exemptions from Devices regulations during the coronavirus
Panagiotakopoulou, M Benozzi, F Menotto, M Casarotto; Supervision: MG (COVID-19) outbreak; 2020 [cited 2020 Mar 25]. https://www.gov.
Bonavina, G Spina, D Gregori. uk/guidance/exemptions-from-devices-regulations-during-the-coro
navirus-covid-19-outbreak.
19. MHRA M-a-H-P-R-A: specification for ventilators to be used in UK
Availability of data and materials hospitals during the coronavirus (COVID-19) outbreak; 2020 Mar
[cited 2020 Mar 24]. https://www.gov.uk/government/publications/
Data on Covid-19 are available here: https://r-ubesp.dctv.unipd.it/shiny/ specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-
covid19ita/ coronavirus-covid-19-outbreak
20. Guidance on medical devices, active implantable medical
devices and in vitro diagnostic medical devices in the COVID-
References 19 context
21. FoodAndDrugAdministration: coronavirus (COVID-19) Update: FDA
1. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospita­ allows expanded use of devices to monitor patients’ vital signs
lized patients with 2019 novel coronavirus-infected pneumonia in remotely; 2020 [cited 2020 Mar 24]. https://www.fda.gov/news-
Wuhan, China. JAMA. February 7, 2020. DOI:10.1001/ events/press-announcements/coronavirus-covid-19-update-fda-
jama.2020.1585 allows-expanded-use-devices-monitor-patients-vital-signs-
2. Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. remotely.
2020;395(10231):1225–1228. 22. Liu C, Mao Z, Kang H, et al. Regional citrate versus heparin antic­
3. Mirco Nacoti AC, Giupponi A, Brambillasca P, et al. Carlo, monta­ oagulation for continuous renal replacement therapy in critically ill
guti: at the epicenter of the Covid-19 pandemic and humanitarian
 EXPERT REVIEW OF MEDICAL DEVICES 489

patients: a meta-analysis with trial sequential analysis of rando­ 24. Lodi CA, Vasta A, Hegbrant MA, et al. Multidisciplinary evaluation
mized controlled trials. Crit Care. 2016;20(1):144. for severity of hazards applied to hemodialysis devices: an original
23. Patel BK, Wolfe KS, Pohlman AS, et al. Effect of noninvasive ventila­ risk analysis method. Clin J Am Soc Nephrol. 2010;5(11):2004–2017.
tion delivered by helmet vs face mask on the rate of endotracheal 25. COVID-19: All haemofiltration systems including machines and
intubation in patients with acute respiratory distress syndrome: a accessories – serious risks if users don’t follow manufacturer
randomized clinical trial. JAMA. 2016;315(22):2435–2441. instructions for set-up (MDA/2020/013)