Coronavirus & the 2nd Generation NObreath® Update

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My patient has cold/flu-like symptoms – can they still perform a breath test?

As a global company, we must first and foremost advise that you follow your local guidelines on whether or not you should continue breath testing at this time.

Please be advised that patients with cold/flu-like symptoms can pose a higher risk of cross infection.

 

What precautions can I take to reduce the risk of cross-infection?

At this time, Bedfont® suggests the following measures to help reduce the risk of cross-infection:

  • Throughout the consultation, wear disposable gloves and other PPE such as a facemask.
  • Wash hands before and after as per your clinical guidelines
  • Ensure the area is well ventilated
  • Ensure to maintain the minimum, recommended distance from patients as per your clinical guidelines, please note: none of Bedfont® breath monitors require a test technique that generates aerosols. A list of aerosol generating procedures (AGP) can be found here.
  • Healthcare professionals should allow their patient to hold the monitor when carrying out a breath test. Once the breath test has been completed, the monitor should be cleaned with anti-viral and anti-bacterial wipes provided with the monitor.
  • The mouthpiece should be disposed of in accordance to the local infection control guidelines.

Is FeNO monitoring an aerosol generating procedures (AGP)?

Risks associated with performing lung function tests during the COVID-19 pandemic has been reviewed by established respiratory organisations. ARTP (Association for Respiratory Technology and Physiology) and PCRS (The Primary Care Respiratory Society) published guidance on FeNO testing during pandemic times. Both supported the idea that FeNO testing was a low effort procedure, therefore was unlikely to induce aerosol generating events, such as coughing5-6.

Additionally, compared to other well established respiratory tests such as spirometry, FeNO testing has been considered a lower risk in comparison suggested in a statement released in September 2020 by PCRS6.

The breath testing procedures for both the 1st and 2nd generation NObreath® FeNO monitors do not require patients to forcefully exhale, only to gently exhale at a steady pace until the test is complete. For this reason, breath testing, and FeNO monitoring in particular, are not considered as AGPs, as deemed by Public Health England9.

There have been no reports of coughing experienced from the use of the 1st or 2nd generation NObreath®. The recent NObreath® clinical study and all usability studies performed since the launch of the 1st and 2nd generation NObreath® examining the monitors safety and performance show that there have been no coughing related events.

We are working around the clock to provide you with current and correct information. Please check back daily for all updates regarding Coronavirus and the Bedfont® products and consumables.

 

How safe is the 2nd generation NObreath® Mouthpiece?

The Second Generation NObreath® Mouthpiece has an infection control filter, which has been tested vigorously by Public Health England to prove it removes and trap >99% and >98% of airborne bacteria and viruses respectively8.

The NObreath® mouthpiece has been tested to filter viruses as small as 23 nanometres in diameter and the COVID-19 virus particle has an approximate diameter of approximately 125 nanometres2. Due to the risky nature of testing live respiratory viruses, a non-pathogenic virus model is used (M2-Coliphage). The filters undergo both bacterial filter efficiency (BFE) and viral filtration efficiency (VFE). The virus model is incredibly penetrable, even more so than a majority of human viruses, therefore makes it a very affective model to use for virus filtration efficiency (VFE) testing. The model virus is approximately 24-26 nanometres in size 1 in comparison to COVID-19 virus which is approximately 125 nanometres in size 2. Therefore, Bedfont® can conclude that bacterial and viral pathogens (including COVID-19) will effectively be removed by both the NOBreath® mouthpiece filter at an efficiency rate of >99% (Bacteria) and >98% (viruses)8.

The NObreath® Mouthpiece is a single-patient use mouthpiece, meaning it should be disposed of according to local waste guidelines immediately after testing to further minimise the risk of cross infection.

Furthermore, when taking a FeNO measurement with the NObreath®, due to our uniquely designed NO scrubber and software algorithms, the patient does not inhale through the device or mouthpiece before exhaling, to reduce the risk of cross-infection.

 

Can I use other mouthpieces/consumables to make it safer for my patients?

Use of counterfeit or non-Bedfont® approved accessories and consumables may result in loss of performance and/or damage to your device. This risk of incorrect results could adversely affect patient care. We also remind you that counterfeit and/or non-Bedfont® accessories and consumables do not possess the quality and reliability of the original manufacturer products, nor have they undergone the Toxicology tests to ensure they are fit to be used orally, and therefore their safety and infection control efficacy cannot be guaranteed.

 

I’m trying to identify a cleaning product that is effective against Coronavirus and also safe for our devices. I know that we aren’t supposed to use alcohol products for example.

NHS customers should follow procedures given by the NHS and the rest of the world should please follow their local guidelines, followed by the Infection Control and Maintenance Guidelines provided by Bedfont®.

As standard practice, Bedfont® recommends that the monitors are wiped down with non-alcoholic antibacterial/viral wipes, provided with the monitor, after each breath test.

The World Health Organisation has labelled the latest strain of coronavirus as Covid-19. The virus that causes the disease has been named as SARS-CoV-2. The Azo Universal wipes provided with the Bedfont® monitors have been tested by the supplier and found effective against SARS-CoV-2, as the product shows efficacy against feline coronavirus, a surrogate coronavirus for SARS-CoV-2. A test report can be shown on request.

We have also conducted testing on a 0.5% Sodium Hypochlorite solution, which was found be effective against SARS-CoV-2. Testing found that a solution of this strength had little effect on the readings and we can safely confirm that Sodium Hypochlorite with a solution ≤0.5% can be applied directly to the NObreath® monitor for cleaning. Test report 138.322 can be shown on request.

Please see the next question about hand sanitiser containing alcohol.

 

I know we cannot use alcohol to clean the products, but can I still use a hand sanitiser containing alcohol before using the monitor?

During the current COVID-19 risk, we understand that using only non-alcohol sanitising products may not be feasible at this time. It is for this reason that we have tested the potential impact alcohol hand sanitising gels might have on device results. From the data obtained, it appears that commonly used hand sanitisers contain up to 73.5% alcohol, therefore we have carried out strenuous testing with a number of hand gels up to this alcohol percentage, using the NObreath® monitors after the hand sanitiser has completely dried.

After using and allowing hand sanitiser to dry, it was shown to have little effects on the results given by the NObreath®. Therefore, we can conclude that hand sanitising products with an alcohol content lower than 73.5% can be used when handling the NObreath® monitors, once hands have dried.

If you are worried the sensor is reading incorrectly, please check accuracy of the sensor using the CO that is supplied by Bedfont® (please refer to user manual about how to do this). Alternatively, you can send the device back to Bedfont®/distributor so we can check your device is performing correctly.

Alcohol sanitisers containing more than 73.5% alcohol should be avoided due to the lack of testing with regard to the impact it could have on readings.

A device accuracy test should be performed periodically to ensure the monitor is working as intended. This can be done with a canister of gas, which can be purchased from Bedfont®.

How effective is SteriTouch® against Coronavirus?

We are proud to say the NObreath® monitor is integrated with SteriTouch® antimicrobial additives, which eradicate the bacteria that cause contamination and infection. SteriTouch® has released a statement on COVID-19 which reads, ‘Several of the active substances used by SteriTouch® have been successfully tested against other enveloped viruses, such as Influenza, Avian flu and SARS. It would be reasonable to imply that those same active substances would be effective against COVID-19, but at this stage testing against COVID-19 is not available3.’ For further information on Coronavirus and SteriTouch®, we recommend you visit the SteriTouch® information page: https://www.steritouch.com/portfolio-posts/coronavirus-steritouch-stance/

If you would like to take extra precautions at this time, Bedfont® recommends wearing gloves when handling the NObreath®.

NHS customers should follow procedures given by the NHS

(https://www.nhs.uk/conditions/coronavirus-COVID-19/ )4 and the rest of the world should please follow their local guidelines, followed by the Infection Control and Maintenance Guidelines provided by Bedfont®.

 

References:

  1. Berkeywaterkb.com. 2020. Is The MS2 – Fr Coliphage Still Known To Be A Good Indicator Of Virus Filtration? Do You Have Tests On Any Other Viruses? – Berkey Knowledge Base. [online] Available at: http://berkeywaterkb.com/is-the-ms2-fr-coliphage-still-known-to-be-a-good-indicator-of-virus-filtration-at-least-one-article-suggests-that-it-might-not-be-do-you-have-tests-on-any-other-viruses/ [Accessed 12 June 2020].

 

  1. Avon-protection.com. 2020. [online] Available at: https://www.avon-protection.com/downloads/product_brochures/GR04471-01%20Coronavirus%20-%20WHITE%20PAPER.pdf [Accessed 12 June 2020].

 

  1. SteriTouch. 2020. CORONAVIRUS – THE STERITOUCH STANCE. [online] Available at: https://www.steritouch.com/portfolio-posts/coronavirus-steritouch-stance/ [Accessed 12 June 2020]

 

4.NHS. 2020. Coronavirus (COVID-19). [online] Available at: https://www.nhs.uk/conditions/coronavirus-covid-19/  [Accessed 12 June 2020]

 

  1. Artp.org.uk. 2021 [Internet]. Artp-uk.org [cited 25 January 2021]. Available from: https://www.artp.org.uk/write/MediaUploads/Standards/COVID19/ARTP_COVID_Practical_Innovations_Vers1.2_final.pdf

 

  1. PCRS Position Statement Diagnostic work up of the patient presenting with respiratory symptoms during the COVID-19 pandemic [Internet]. Pcrs-uk.org. 2021 [cited 25 January 2021]. Available from: https://www.pcrs-uk.org/sites/pcrs-uk.org/files/resources/COVID19/Diagnosis-asthma-COPD-during-Covid-19-v2-17-September-2020.pdf

 

  1. Public Health England. 091.010 NObreath Accessories Mouthpiece Performance Test Report. London: Public Health England; 2009.

 

  1. Public Health England. An Evaluation of Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges. Salisbury: Public Health England; 2020.

 

  1. COVID-19: Guidance for maintaining services within health and care settings [Internet]. Assets.publishing.service.gov.uk. 2021 [cited 26 January 2021]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/954690/Infection_Prevention_and_Control_Guidance_January_2021.pdf