Important Safety Information | NIOX VERO® User Manual (PDF)

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For questions about coronavirus/COVID-19 and using NIOX VERO®, please visit the NIOX VERO Coronavirus/COVID-19 FAQ.

Coronavirus FAQ

Covid-19: A personal message to our customers and partners

The world is facing an unprecedented human challenge with COVID-19. We stand together in supporting healthcare professionals around the world, who we have worked in close partnership with for many years.

Recognising the extreme challenges that healthcare professionals face every working day, we wanted you to know that we are here for you and that the entire NIOX® team are available to support you during these difficult times. Our Medical Affairs team are ready and waiting to answer any questions or to provide support on FeNO testing.

Behind the scenes, the NIOX team have been working tirelessly to ensure that we have been able to safely maintain supply of NIOX devices and accessories, so that healthcare professionals can deliver the care that their asthma patients need at this critical time. It is important to mention that the health and wellbeing of our people is of the upmost importance. To maintain the reliable supply of NIOX, we have devised new working practices and safety measures to ensure that the team can work safely and effectively.

We are very proud of the Circassia team for their dedication and passion during these challenging times and want to take this opportunity to publicly thank them.

We know that science will win, in the end. In the meantime, you can depend on the Circassia team to stand with you and support you.

Stay safe
Ian Johnson (Executive Chairman)
Jonathan Emms (Chief Operating Officer)

What have we done so far?

During these unprecedented times, we have taken steps to introduce procedures that keep our colleagues safe and ensure our customers are fully supported.

Currently, all Circassia colleagues who can do so are working from home, but you can still contact us through your local representative, head office, customer service, technical support and operations by using the normal telephone number or email address.

As part of our commitment, we have implemented virtual training sessions and a remote installation service to support our customers and help assist with the diagnosis and management of patients with asthma, using FeNO testing.

Circassia firmly believes in following the evidence and is therefore funding clinical research looking at lung function testing in COVID-19 patients. We also understand that a research group in South America are studying whether FeNO can be used to assist in COVID-19 patient management.

The importance of lung function testing in the COVID-19 pandemic

New international guidance has been issued which recommends the reintroduction of lung function testing for areas which are past the peak of the COVID-19 pandemic and entering a new phase of patient care. 1,2 Maintaining asthma control and following the individuals’ Asthma Plan continues to be critical during this time 3-5; this includes the importance of FeNO testing.6

FeNO is a validated biomarker of Type 2 inflammation and is the least invasive technique for measuring this inflammation. FeNO testing has not been classified as an aerosol generating procedure7-10 and breathing required to complete a test is done purely via the filtered mouthpiece of the NIOX device itself.11

FOR HEALTHCARE PROFESSIONALS, please find additional links here which could help support your treatment decisions:



PATIENT RESOURCES:

FeNO testing with NIOX VERO

How can I continue to use FeNO to manage my patients with asthma during this period?

The NIOX VERO device utilises single-use patient mouth-filters, designed to prevent the spread of pathogens between patients and every NIOX sensor pack includes sufficient patient filters to accommodate a new filter for each test. 11 Viral and bacterial filter efficiency is answered below.

Local infection control guidelines and policies should always be followed in the first instance. In addition, the World Health Organization published helpful guidance to provide further advice on risk management following suspected coronavirus infection.12,13 Based on recent UK government advice, we would endorse the following strategies to support the use of FeNO testing:14

  • Where possible, FeNO testing should be carried out in a single room with the doors shut
  • Full PPE should be worn according to local guidelines
  • Disposable gloves to be worn by each patient when they are holding the device handle
  • Appropriate hand hygiene measures throughout

How effective are the NIOX VERO patient filters?

The bacterial and viral filtration efficiencies of the disposable NIOX VERO mouth filter are exceptionally high at ≥99.97%15 and ≥99.24% for the nasal NIOX filter16-17

The disposable, single-use mouthpiece filter or nasal attachment must be changed for each new patient but may be used on multiple occasions in the same session (by the same patient). 11

NIOX VERO mouth and nasal filters meet international standards of filtration performance for, “Breathing System Filters for Anaesthetic and Respiratory Use” (ISO 23328-1, EN 13328-1), which many other respiratory devices in hospital settings also adhere to. The filters have been tested for bacterial filtration efficiency (BFE) and viral filtration efficiency (VFE) to the highest ASTM standard F2101. The BFE of the mouthpiece filter is ≥99.99% and the VFE is ≥99.97%.15 The BFE of the nasal filter is ≥ 99.93% and the VFE is ≥ 99.24%.16-17

In vitro studies were independently conducted to test the viral efficiency of the NIOX filters.15-17 A microbe 4 times smaller than the size of SARS-CoV-2 (COVID-19 virus) was used as the surrogate to test the filters’ efficiency in preventing it from crossing through the filter.18-20

How should I clean and disinfect the NIOX VERO?

NIOX VERO should be regularly cleaned and decontaminated, as with all surfaces in a patient-care setting.

Alcohol containing disinfectants (such as ethanol and isopropyl alcohol) must not be used for cleaning the NIOX VERO device or breathing handle, as this will affect both the performance and results generated.11 However, several products are compatible with NIOX devices including:

  • Sodium hypochlorite (<0.65%),
  • Quaternary ammonium compounds such as Benzalkonium chloride (<5%),
  • Biguanides such as Polyhexamethylene biguanide, Chlorhexidine digluconate or Poly (hexamethylene biguanide) hydrochloride (<1%),
  • Isothiazolinones such as 2-methyl-2H-isothiazol-3-one or 5-chloro-2-methyl-2H-isothiazol-3-one (<0.01%).


In regards to COVID-19 specifically:21-27 Sodium hypochlorite 0.5-0.65% is effective against SARS-CoV-2, (the coronavirus causing COVID-19) and can be used to clean the NIOX VERO device itself.13-18 Benzalkonium chloride 0.05-0.2% is also an effective cleaning agent against SARS-CoV-2 and is compatible with NIOX.13-18

Further Questions

If you would like more information or have further questions, please contact our Medical Affairs team at medical.information@circassia.com.

References

  1. European Respiratory Society. ERS 9.1 Statement on lung function during COVID-19. “The following is a recommendation for healthcare professionals performing lung function testing during the COVID-19 pandemic” May 2020. https://ers.app.box.com/s/zs1uu88wy51monr0ewd990itoz4tsn2h
  2. Association for Respiratory Technology & Physiology. V1.5 Respiratory Function Testing During Endemic COVID-19. May 2020. https://www.artp.org.uk/write/MediaUploads/Standards/COVID19/Respiratory_Function_Testing_During_Endemic_COVID_V1.5.pdf
  3. Moore, A. COVID-19 and asthma. America Academy of Allergy Asthma & Immunology. (April 2020). https://www.aaaai.org/conditions-and-treatments/library/asthma-library/covid-asthma Last accessed 14th May 2020
  4. National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. People who are at higher risk (April 2020). https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/asthma.html Last accessed 14th May 2020
  5. Asthma UK. What should people with asthma do now? (May 2020) https://www.asthma.org.uk/advice/triggers/coronavirus-covid-19/what-should-people-with-asthma-do-now/#ManageAsthma Last accessed 14th May 2020
  6. Menzies-Gow A, et al. Clinical utility of fractional exhaled nitric oxide (FeNO) in severe asthma management. European Respiratory Journal 2020; DOI: 10.1183/13993003.01633-2019 https://erj.ersjournals.com/content/early/2020/01/03/13993003.01633-2019 Last accessed 9th June 2020
  7. Hull J. Lancet Respir Med 2020 Published Online May 29, 2020 https://doi.org/10.1016/ S2213-2600(20)30246-0 https://www.thelancet.com/pdfs/journals/lanres/PIIS2213-2600(20)30246-0.pdf Last accessed 9th June 2020
  8. Public Health England. COVID-19: infection prevention and control guidance (pages 32-33). 21st May 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/886668/COVID-19_Infection_prevention_and_control_guidance_complete.pdf Last accessed 9th June 2020
  9. Centers for Disease Control & Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19 (29 May 2020) https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html Last accessed 9th June 2020
  10. Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J (2012) Aerosol Generating Procedures and Risk of Transmission of Acute Respiratory Infections to Healthcare Workers: A Systematic Review. PLoS ONE 7(4); https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3338532/#!po=72.2222external iconexternal icon). Last accessed 9th June 2020
  11. In the US: NIOX VERO User Manual 000190-13 (EPM-000165). Circassia Pharmaceuticals. September 2019. https://www.niox.com/pdf/niox-vero-user-manual-en-us.pdf. Outside US: NIOX VERO User Manual 000191-13 (EPM-000167). Circassia Pharmaceuticals. August 2019. https://www.niox.com/pdf/niox-vero-user-manual-en.pdf Last accessed 14 May 2020
  12. World Health Organization (WHO). Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected. Interim guidance. 25 January 2020. https://www.who.int/publications-detail/infection-prevention-and-control-during-health-care-when-novel-coronavirus-(ncov)-infection-is-suspected-20200125 Last accessed 14th May 2020
  13. World Health Organization (WHO). Laboratory biorisk management for laboratories handling human specimens suspected or confirmed to contain novel coronavirus: Interim recommendations. 19 February 2013. https://www.who.int/csr/disease/coronavirus_infections/Biosafety_InterimRecommendations_NovelCoronavirus_19Feb13.pdf Last accessed 14th May 2020
  14. Public Health England. COVID-19: infection prevention and control guidance. 27th April 2020. https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control/wuhan-novel-coronavirus-wn-cov-infection-prevention-and-control-guidance#decon Last accessed 14th May 2020. https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control/covid-19-personal-protective-equipment-ppe#section-8point1 Last accessed 14th May 2020
  15. Data on file (002453). BFE, VFE and NaCL Summary Report at Increased Challenge Level Final Report (July 2014).
  16. Data on file (107S947-S01). Bacterial Filtration Efficiency (BFE) at Increased Challenge Final Report (July 2018).
  17. Data on file(1072934-S01). Viral Filtration Efficiency (VFE) at Increased Challenge Level Final Report (July 2018).
  18. Data-on-file (Ext. Report). “Coronavirus and barrier material tests” (April 2020).
  19. Laue M, Moller L. Robert Kock Institute. SARS-CoV-2 Diagnostic EM 202000327 using validated protocol https://doi.org/10.3390/v7020666) Last accessed 14th May 2020
  20. Liu Y et al. Aerodynamic Characteristics and RNA concentration of SARS-CoV-2 aerosol in Wuhan Hospitals during COVID-19 outbreak (2020). doi: https://doi.org/10.1101/2020.03.08.982637 Last accessed 14th May 2020
  21. World Health Organization. Q&A on infection prevention and control for health care workers caring for patients with suspected or confirmed 2019-nCoV. What are the disinfectants recommended for environmental cleaning in healthcare facilities or home housing patients with suspected or confirmed 2019-nCoV infection? 16 February 2020. https://www.who.int/news-room/q-a-detail/q-a-on-infection-prevention-and-control-for-health-care-workers-caring-for-patients-with-suspected-or-confirmed-2019-ncov Last accessed 14th May 2020
  22. The National Environment Agency. Interim list of household products and active ingredients for disinfection of the COVID-19 virus. 01 March 2020. https://www.nea.gov.sg/our-services/public-cleanliness/environmental-cleaning-guidelines/guidelines/interim-list-of-household-products-and-active-ingredients-for-disinfection-of-covid-19 Last accessed 14th May 2020
  23. United States Environmental Protection Agency. List N: disinfectants for use against SARS-CoV-2. 03 March 2020. https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2 Last accessed 14th May 2020
  24. Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infect 2020;104(3):246-251. https://doi.org/10.1016/j.jhin.2020.01.022 Last accessed 14th May 2020.
  25. European Centre for Disease Prevention and Control (ECDC). Interim Guidance. 18th Feb 2020. https://www.ecdc.europa.eu/sites/default/files/documents/coronavirus-SARS-CoV-2-guidance-environmental-cleaning-non-healthcare-facilities.pdf Last accessed 14th May 2020.
  26. Health Canada. Hard-surface disinfectants and hand sanitizers (COVID-19): List of disinfectants for use against COVID-19 https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/list.html Last accessed 14th May 2020
  27. Rabenau HF et al. Efficacy of various disinfectants against SARS coronavirus Journal of Hospital Infection (2005) 61, 107–111