For US Healthcare Professionals Only
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.
Recognizing 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.
Ian Johnson (Executive Chairman)
Jonathan Emms (Chief Operating Officer)
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.
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
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
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
In vitro studies were independently conducted to test the viral efficiency of the NIOX filters. 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.17*
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:
In regards to COVID-19 specifically:18-24 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
If you would like more information or have further questions, please contact our Medical Affairs team at firstname.lastname@example.org.
*NIOX filters have not been tested specifically with regard to SARS-CoV-2.
1. European Respiratory Society. ERS 9.1 Statement on lung function during COVID-19European Respiratory Society (ERS) Recommendations on Lung Function Testing During the COVID-19 Pandemic and Beyond. May 2020. https://ers.app.box.com/s/zs1uu88wy51monr0ewd990itoz4tsn2h(last accessed 26 April 2021).