Gastrolyzer COVID-19 Update

COVID-19, more commonly referred to as Coronavirus, has become an increasing concern, especially in the world of medical devices. We have collated the following information to hopefully answer any questions you may have about the use of Gastrolyzer® devices and consumables.

 

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. Bedfont® does not recommend breath testing of patients with cold/flu symptoms.

 

Can remote breath testing still be done with the GastroCH4CK® Gastrolyzer® breath bags?

First and foremost we must ask that you follow your local guidelines on continuing Hydrogen and Methane Breath Testing (HMBT) at this time.

The British Society of Gastroenterology have published their guidelines on carry out GI testing during these current conditions, and recommend home kits for HBMT procedures, which allow patients to carry out the test at home instead of the hospital/clinic environments4.

Therefore, when using the GastroCH4ECK® breath bags in home kits for remote HBMT testing, Bedfont® advises the following:

A study published in the New England Journal of Medicine revealed plastic is the surface the virus remains viable on for the longest – up to 72 hours. On stainless steel, the virus was detected up to 48 hours after application. For cardboard it was 24 hours and for copper just 4 hours2. Therefore first consider leaving the samples in quarantine for 72 hours before sampling.

Before sampling, wipe down the sample bags with non-alcoholic antibacterial/viral wipes, provided with the monitor.

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

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/sample.

 

How safe are the GastroCH4ECK® Mouthpieces?

The GastroCH4ECK® mouthpiece has an infection control filter, which has been tested vigorously by Public Health England to prove it removes and trap >99% of airborne bacteria and viruses. It has been tested to filter viruses as small as 24 nanometres in diameter and the COVID-19 virus particle has a diameter of approximately 125 nanometres1. 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 size1 in comparison to COVID-19 virus which is approximately 125 nanometres in size1. Therefore, Bedfont can conclude that bacterial and viral pathogens (including COVID-19) will effectively be removed by GastroCH4ECK® mouthpiece filter at an efficiency rate of >99%.

The GastroCH4ECK® 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.

 

How safe are the D-piece® mouthpiece filters for the Gastro+™?

The D-piece™ incorporates a one-way valve and an infection control filter, which has been tested vigorously by Public Health England to prove it removes and trap 99% and 97% of airborne bacteria and viruses respectively. Bedfont recommends the D-piece™ can be used for a continuous 30 days in conjunction with single-patient-use SteriBreath™ mouthpieces.

Both the D-piece™ filter and OneBreath™ mouthpiece have been tested to filter viruses as small as 24 nanometres in diameter and the COVID-19 virus particle has a 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 size1 in comparison to COVID-19 virus which is approximately 125 nanometres in size2. Therefore, Bedfont can conclude that bacterial and viral pathogens (including COVID-19) will effectively be removed by both the D-piece™ filter and OneBreath™ mouthpiece filter at an efficiency rate of >99% (bacteria) and >97% (viruses).

 

How effective is SteriTouch® against Coronavirus?

We are proud to say the Gastro+™ 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 available.’ 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 Gastrolyzer® devices.

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

Gastro+™ Infection Control and Maintenance Guidelines

GastroCH4ECK Infection Control and Maintenance Guidelines

 

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:

If possible, wear gloves when handling the Gastrolyzer® monitors.

Do not let the patient hold the monitor when performing the test – it is recommended at this time that the healthcare professional should hold the device.

It is recommended at all times that the patient should dispose of their mouthpiece at the end of the test, as stated in the Infection Control Maintenance Guidelines.

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

 

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.

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 Gastro+™ monitors for cleaning, a test report can be shown on request.

The GastroCH4ECK® has yet to be tested, Bedfont® are working around the clock to provide this and will update once testing has been completed.

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.

A device accuracy test should be performed periodically to ensure it is working as intended.

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

If you wish to review any of the reports mentioned above, please email ask@bedfont.com.

References

  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. 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/#:~:text=The MS-2 virus is 24-26,both referenced on the chart [Accessed 12 June 2020].

 

  1. New England Journal of Medicine. 2020. Aerosol And Surface Stability Of SARS-Cov-2 As Compared With SARS-Cov-1 | NEJM. [online] Available at: https://www.nejm.org/doi/full/10.1056/NEJMc2004973 [Accessed 12 June 2020].

 

  1. The British Society of Gastroenterology. 2020. AGIP Council Guidance In Relation To GI Physiology Provision During The COVID-19 Pandemic | The British Society Of Gastroenterology. [online] Available at: https://www.bsg.org.uk/covid-19-advice/agip-council-guidance-in-relation-to-gi-physiology-provision-during-the-covid-19-pandemic/ [Accessed 12 June 2020].