Month: August 2024

Methods of measuring FeNO

Fractional exhaled nitric oxide (FeNO) measurement plays a crucial role in the diagnosis and management of airway inflammation. FeNO testing is recommended by the National Institute for Health and Care Excellence (NICE) to help diagnose asthma¹, with the NObreath® device one of three devices recommended by NICE¹.

In 2005 the American Thoracic Society (ATS) and the European Respiratory Society (ERS) published recommendations for standardised procedures of FeNO testing highlighting that whilst evidence shows ambient levels of nitric oxide (NO) do not affect the result; it is preferable to avoid doubt by removing it from the breath sample². This can be done by either ‘partitioning’ the sample; effectively ignoring the potential initial spike caused by ambient NO, or another method is inhaling through an NO scrubber before exhalation.

The NObreath® utilises the partition method. This article explores the partitioning method, how it works, and why Bedfont® Scientific Limited selected this method for the NObreath® device.

What is the partition method?

The partition method essentially ‘parts’ the breath sample, and omits the first few seconds to ensure any potential high ambient levels of NO present in the breath are not measured during sampling.

When performing a breath test with the NObreath®, the user will be prompted to take a deep breath and then instructed to blow gently into the mouthpiece with an onscreen flow meter to guide the patient on their exhalation rate. The NObreath® offers two test modes: A 12-second test mode and a 10-second test mode for those up to 10 years old who cannot complete the 12-second test mode.

As the breath sample enters the NObreath® device, the first few seconds are partitioned and vented through the device bypassing the sensor chamber. After the partition period has elapsed, the pump will draw the remaining viable sample into the sensor chamber, where the breath sample will be analysed. When the patient completes a breath test using the NObreath® a green tick will appear on the screen to indicate a successful test, and the patient’s results will be shown onscreen in parts per billion (ppb) instantly.

The NObreath® applying the partitioning method

The partition method is a user-friendly method designed to measure airway inflammation, providing instant results, and eliminating wait times for both patients and healthcare professionals. The patient does not have to inhale through a device that has been used on multiple prior patients, as even highly effective bacterial viral filters may not be 100% effective and the patient does not have to inhale through an NO scrubber*. Avoiding inhalation means these risks do not arise and this is another reason why Bedfont® chose this technique for NObreath®. The NObreath® also utilises an NO scrubber for accuracy but this does not form any part of the breath pathway.

To learn more about the NObreath® utilising partitioning method, please visit https://www.nobreathfeno.com/measuring-feno-with-the-nobreath/

FeNO testing

The use of FeNO testing, combined with a comprehensive clinical history and additional examinations, enhances the efficiency of asthma diagnosis and improves patient care. This allows for effective monitoring of patients’ responses to asthma interventions. Bedfont® are world leaders in breath analysis, with over 47 years of experience. Bedfont® has been manufacturing the NObreath® portable FeNO device for over 15 years. Used by healthcare professionals to measure airway inflammation to aid in the diagnosis and management of asthma, taking a minimal amount of valuable consultation time with the ability to monitor airway inflammation in both adult and child patients. With annual servicing and minimal consumables, the NObreath® can be used as a functional device for years**.

Visit https://www.nobreathfeno.com to learn how to support your patients with FeNO monitoring using the NObreath® from Bedfont® Scientific Limited.

*NO scrubbing filters typically utilise potassium permanganate (a potentially hazardous substance) which has been referenced in certain conditions, if inhaled, to cause irritation to the nose, throat and lungs causing coughing and/or shortness of breath^3,4,5,6.

**The NObreath® has been validated for up to 29,000 tests when used as instructed and properly maintained and serviced. The number of tests can be periodically checked within the settings of the device; when 29,000 tests are reached a service is recommended. Contact your local service centre.

References:

1. Measuring fractional exhaled nitric oxide concentration in asthma: NIOX MINO, NIOX VERO and NObreath [Internet]. National Institute for Health and Care Excellence. 2014. [Cited Monday 12^th August 2024]. Available from: https://www.nice.org.uk/guidance/dg12/chapter/1-Recommendations
2. American Thoracic Society Documents. ATS/ERS recommendations for standardised procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005;171(8):912-30. DOI: 10.1164/rccm.200406-710ST.
3. Hazardous substance fact sheet [Internet]. New Jersey Department of Health and Senior Services. 2002. [Cited Monday 12^th August 2024]. Available from: https://nj.gov/health/eoh/rtkweb/documents/fs/1578.pdf
4. Safety data sheet potassium permanganate [Internet]. AquaPhoenix Scientific. 2015. [Cited Monday 12^th August 2024]. Available from: https://beta-static.fishersci.com/content/dam/fishersci/en_US/documents/programs/education/regulatory-documents/sds/chemicals/chemicals-p/S25497.pdf
5. . Potassium permanganate permanganic acid potassium salt [Internet]. Safety International Chemical Cards. 2016. [Cited Monday 12^th August 2024]. Available from: https://www.ilo.org/dyn/icsc/showcard.display?p_lang=en&p_card_id=0672&p_version=2
6. Potassium permanganate safety data sheet [Internet]. LabChem. 2014. [Cited Monday 12^th August 2024]. Available from: https://palsusa.com/wp-content/uploads/sites/6/2024/08/POTASSIUM-PERMANGANATE.pdf

A door opens to ensure the gold standard of FeNO testing is available in Latin America.

Bedfont® Scientific Limited, world leaders in breath analysis, with over 47 years of experience in the manufacturing and distribution of breath analysis devices have partnered with worldwide respected medical company Geratherm® Group, to enable them to manufacture a Fractional exhaled Nitric Oxide (FeNO) testing device.

Geratherm® Group predominantly known for their medical glass thermometers are an internationally aligned group that develop and produce medical solutions from respiratory therapy to women’s health at its five locations in Germany. They export 82% of their products to over 60 different countries every year, with many products in use in practices, clinics and rehabilitation facilities worldwide.

Their Latin America sales office, which was founded in May 2002 based in Brazil, is currently the focal point for sales, warehousing and customer service from Mexico to Chile for the entire group. This is where the partnership begins between Bedfont® and Geratherm®.

Marcio Souza, CEO of Geratherm® Medical Latin America visited the Bedfont® premises back in April, for a tour of the company, to oversee production. During the visit, final details were discussed and an agreement was reached.

Marcio Souza, CEO of Geratherm® says “We are excited to announce a new commercial partnership with Bedfont®, a recognised leader in the medical field, focused on respiratory analysis. This collaboration aims to bring the Brazilian market the best FeNO device available in the medical area, which will allow us to offer innovative and quality solutions to Latin American markets. Together, we are committed to delivering all benefits such as improving patient health, increasing efficiency, better costs and faster exam results. We believe that this union will be an important milestone in the advancement of medicine and the transformation of the healthcare experience.”

Adding to their already extensive well established product listing, Bedfont® are supplying the FeNObreath® kit which will allow Geratherm® to manufacture a FeNO testing device. Adding a FeNO device to their listing is a huge step forward in aiding the diagnosis and treatment of asthma in Latin America.

FeNO is a gas that is produced when airways are inflamed, a typical symptom of asthma. By measuring the FeNO on a person’s breath you can differentiate between allergic asthma and non-allergic asthma, as well as monitoring a person’s adherence to medication. A FeNO testing device is a great tool for asthma management and will certainly boost Geratherm’s already impressive catalogue of products.

Jason Smith, Managing Director of Bedfont® says “We are thrilled to announce our strategic partnership with Geratherm® for the manufacturing of our innovative FeNO device. This collaboration marks a significant milestone in our efforts to expand access to FeNO testing in Latin America. By leveraging Geratherm’s manufacturing expertise and our cutting-edge technology, we are poised to make a substantial impact on respiratory health management in the region. This partnership not only strengthens our global footprint but also reaffirms our commitment to improving patient care through advanced diagnostic solutions.”

For more information on how FeNO testing is revolutionising asthma care, visit nobreathfeno.com

FeNO Testing in Asthma Care

Although airway eosinophilic inflammation is a key characteristic of asthma, there are few methods available to measure it. This inflammation can be assessed by measuring eosinophils and eosinophilic cationic protein (ECP) in sputum or by measuring ECP in blood samples¹. However, these methods are considered time-consuming, expensive, and not readily available.

For most asthma patients, airway inflammation is driven by an allergen-induced Th2 response². Evidence from the literature suggests that fractional exhaled nitric oxide (FeNO) is a crucial biomarker for respiratory tract inflammation². Elevated FeNO levels in asthma are thought to result from inducible NOS2 expression in the inflamed airways². The NObreath® FeNO device provides a non-invasive and significantly more cost-effective alternative aid to diagnose asthma and assess airway eosinophilic inflammation.

This article delves into the challenges encountered within primary care and how the innovative technology of the NObreath® can assist. Additionally, the article discusses the transition of the use of the NObreath® from primary care environments to secondary care facilities.

Challenges in Primary Care

GPs often face restricted budgets due to resource allocation for population needs, and financial sustainability to stay within healthcare budgets and prevent overspending. Each patient appointment is typically limited to just 10 minutes.

Population needs

In the UK, approximately 5.4 million people, or about 8 in every 100 individuals, suffer from asthma³. The National Review of Asthma Deaths (NRAD) documented 195 asthma-related deaths among adults in 2013, highlighting preventable factors in 89 of the 195 deaths (46%), such as lack of specific asthma expertise (17%) and non-adherence to UK asthma guidelines (25%)⁴. FeNO testing is valuable in GP settings, as GPs often encounter a spectrum of asthma cases, from mild to severe. The NObreath® device facilitates rapid and reliable FeNO measurements, to allow GPs to make informed decisions and aid in identifying patients who do or do not require ongoing treatment⁵. This also reduces emergency visits and hospital admissions related to poorly controlled asthma.

Financial sustainability

One of the ongoing challenges in primary care is maintaining financial sustainability. The NObreath® FeNO device is cost-effective, with minimal ongoing costs. The device requires only one consumable- the NObreath® mouthpiece which has a long shelf life and an integrated infection control filter, effectively removes airborne bacteria (>99%) and viruses (>98%)⁶. The device also incurs low annual servicing costs and imposes no test limits*.

Time with patient

When a GP determines the need for a FeNO test using the NObreath®, there’s no warm-up time, and the device operates through a simple exhale-only technique with on-screen visual guidance. Patients receive instant results, eliminating wait times. Intended for adult and paediatric patients**, the NObreath® offers two test modes: a 10-second test mode for those up to 10 years old who cannot complete the 12-second test mode.  GPs can store up to 25 results in up to 50 patient profiles and view a graph of results. If a GP office possesses only one NObreath®, they benefit from the device size and portability, ensuring that healthcare providers can efficiently utilise the device wherever patient care demands.

Carol Stonham, a member of Bedfont® Scientific Limited Medical Advisory Board and policy lead for Policy Care Respiratory Society (PCRS), comments “The NObreath® is my preferred choice for primary care in managing asthma for many reasons. Primarily it suits the unpredictability of the volume of testing in primary care – none of the consumables or device needs to be used or lost in a short time frame. It is an intuitive machine which is easy to use and teaches patients of all ages.”

Primary Care to Secondary Care

Using the NObreath® device in primary care can reduce the number of inappropriate referrals to secondary care clinics. However, if a patient is referred to an asthma specialist in secondary care, the NObreath® FeNO device can aid in the diagnosis and management of asthma. The NObreath® helps differentiate between allergic (eosinophilic) and non-allergic asthma⁷. FeNO measurements show the patient’s response to the treatment, enabling accurate prescription of medication and safer, monitored adjustments. This helps patients understand their condition better by demonstrating how their FeNO levels correlate with their symptoms and treatment adherence. Measuring airway inflammation with the NObreath® can help monitor the effectiveness of medication and predict the risk of asthma attacks⁸***

Gold Standard FeNO Testing

FeNO testing is increasingly recognised as a valuable tool in the management of asthma, but what makes the NObreath® stand out from other FeNO devices on the market? Developed by Bedfont® in 2008, the NObreath® has over 15 years of clinical use and has been featured in numerous studies worldwide, contributing to the advancement of FeNO testing. Conforming to both the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines, the NObreath® is also one of three FeNO devices recommended by the National Institute for Health Care Excellence (NICE)⁹, an independent international organisation providing national guidance and advice to improve health and social care.

To find out how you can support your patients with FeNO testing in asthma care with the NObreath®, please visit: https://www.nobreathfeno.com/

*The NObreath® has been validated for up to 29,000 tests when used as instructed and properly maintained and serviced. The number of tests can be periodically checked within the settings of the device; when 29,000 tests are reached a service is recommended. Contact your local service centre.

**NObreath® can be used on paediatric and adult patients, provided they can follow test protocol. USA only: NObreath® can be used on patients 7+ years old.

***FeNO is not a definitive indication of asthma and should be used in conjunction with (but not limited to) spirometry, patient history, and symptoms.

References:

1. Pizzichini E, Pizzichini MM, Efthimiadis A, Dolovich J, Hargreave FE. Measuring airway inflammation in asthma: eosinophils and eosinophilic cationic protein in induced sputum compared with peripheral blood. Journal of allergy and clinical immunology. 1997 Apr 1;99(4):539-44. DOI: 10.1016/S0091-6749(97)70082-4.
2. Keller AC, Rodriguez D, Russo M. Nitric oxide paradox in asthma. Memórias do Instituto Oswaldo Cruz. 2005;100:19-23. PMID: 15962094 DOI: 10.1590/s0074-02762005000900005.
3. What is Asthma? [Internet]. Asthma+ Lung UK. 2024. [Cited Monday 8^th July 2024]. Available from: https://www.asthmaandlung.org.uk/conditions/asthma/what-asthma#:~:text=Asthma%20is%20a%20common%20condition,cough%20or%20a%20tight%20chest.
4. Royal College of Physicians. Why asthma still kills: the National Review of Asthma Deaths (NRAD) Confidential Report. London, RCP; 2014.
5. Taylor DR, Pijnenburg MW, Smith AD, Jongste J. Exhaled nitric oxide measurements: clinical application and interpretation. Thorax. 2006 Sep 1;61(9):817-27. PMID: 16936238 PMCID: PMC2117092 DOI: 10.1136/thx.2005.056093.
6. Public Health England. An Evaluation of Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges. Salisbury: Public Health England; 2020.
7. Ref: Coumou H, Bel EH. Improving the diagnosis of eosinophilic asthma. Expert review of respiratory medicine. 2016 Oct 2;10(10):1093-103. DOI: 10.1080/17476348.2017.1236688.
8. Saito J, Gibeon D, Macedo P, Menzies-Gow A, Bhavsar PK, Chung KF. Domiciliary diurnal variation of exhaled nitric oxide fraction for asthma control. European Respiratory Journal. 2014 Feb 1;43(2):474-84. DOI: 10.1183/09031936.00048513.
9. Measuring fractional exhaled nitric oxide concentration in asthma: NIOX MINO, NIOX VERO and NObreath [Internet]. National Institute for Health and Care Excellence. 2014. [Cited Wednesday 10^th July 2024]. Available from: https://www.nice.org.uk/guidance/dg12/chapter/5-Outcomes

A series of events and initiatives culminate in remarkable fundraising achievements by Med-Tech company Bedfont® and NewMed.

Bedfont® Scientific Ltd. world leaders in breath analysis, with over 47 years of expertise in the design and manufacture of medical breath analysis devices, welcomed the roaming Shaun the Sheep sculpture to its offices on Friday, 26th July, for the exciting announcement. Bedfont® teamed up with NewMed Ltd. earlier in the year to sponsor and support Heart of Kent Hospice and its various charity events throughout the year, and are extremely proud to have contributed to raising over £28,000.

Heart of Kent Hospice, based in Aylesford, is a charity with a passion for improving quality of life and provides specialist care and support to adults with terminal illnesses. Bedfont®, along with NewMed, have been actively involved in a variety of fundraising events for Heart of Kent Hospice, and have been engaging employees and the community to support this worthy cause.

In May, Bedfont® participated in the Bluebell Walk, following a picturesque walk through the North Downs and raised substantial funds through sponsorships and raffles. Bedfont® also proudly sponsored a beautiful Shaun the Sheep sculpture for the Hospice’s Shaun in the Heart of Kent art trail, the event not only highlights local artistry but also draws significant attention to the hospice’s mission. Additionally, Bedfont® took part in the Shaun the Sheep Selfie Challenge, capturing joyful moments and sharing them widely to further boost donations and awareness.

Jason Smith, Managing Director at Bedfont® Scientific Ltd., comments “At Bedfont®, we believe in the power of community and the importance of giving back. Our partnership with NewMed Ltd. and our ongoing support for the hospice, reflect our commitment to making a positive impact on the lives of those around us. We look forward to continuing our efforts and exploring new ways to support Heart of Kent Hospice in the future”

David Dadswell, Corporate Partnerships Manager at Heart of Kent Hospice, commented “Collaborating with the local business community plays a pivotal role in the Hospice’s strategy, and allows us to create increased awareness of the services we provide and supports our fundraising events to deliver the best experience for all those who participate. Both Bedfont® Scientific and NewMed fully immersed themselves into the recent Bluebell Walk as headline sponsors, exhibitors, and participants and through their efforts, we raised over £28,000. It’s the perfect partnership between organisations that have strong values around healthcare and a commitment to giving back to their local communities.

To find out more about Bedfont® and the continued efforts in supporting Heart of Kent Hospice, follow us on social media @BedfontLtd