Bedfont Scientific Ltd. Makes ToxCO® FDA 510(k) Submission

Bedfont Scientific Ltd. has made a 510(k) submission for US FDA clearance of their ToxCO® monitor used by emergency services to mass screen for carbon monoxide (CO) poisoning.

Bedfont Scientific Ltd. has made a 510(k) submission for US FDA clearance of their ToxCO<sup>®</sup> monitor used by emergency services to mass screen for carbon monoxide (CO) poisoning.

Bedfont, based in the UK, specialists in the design and manufacture of breath analysis medical products, has made an FDA 510(k) submission for clearance to sell one of its breath analysers, the ToxCO®.

Established in 1976, the second-generation family company already has one device on the market in America, their Micro+™ Smokerlyzer® CO monitor to help people quit smoking. Using a similar technology, the ToxCO® is designed for emergency services to mass screen for cases of CO poisoning, providing a quicker method than the traditional blood test. A breath sample can be taken from a patient via mouthpiece, or in instances where the patient is unconscious, by face mask. By being able to mass screen patients on-site, it can rule out unnecessary hospital admissions and save valuable time, furthermore, the ToxCO® has ambient monitoring which begins from switch-on, alerting emergency services to high levels of atmospheric CO at the scene of the incident, helping to safeguard them and be prepared.

Known as the silent killer, CO is a colourless, odourless, highly poisonous gas that is produced when fuels are burned incompletely. Everybody is exposed to CO in everyday life; from boilers, open fires, cars, generators and even burning your toast. CO poisoning is the most common type of fatal poisoning in many countries1. According to the CDC, “during 1999–2010, a total of 5,149 deaths from unintentional carbon monoxide poisoning occurred in the United States, an average of 430 deaths per year”2. Prolonged exposure can lead to severe health consequences, and if exposed for too long, death. An exposure to 12,800ppm of carbon monoxide can kill you within 1-3 minutes3.

Jason Smith, Managing Director at Bedfont, explains, “We are working hard to help raise awareness of breath analysis in the USA and how the ToxCO® has the potential to save so many lives. We are fully committed to working closely everyone involved to have swift and successful FDA clearance for this product.”

Daniel Sibis, Vice President at coVita LLC, Bedfont’s USA distributor, comments, “The ToxCO® will revolutionise how emergency services approach carbon monoxide poisoning. Compared to blood samples, breath analysis with the ToxCO® is quick, easy and completely non-invasive. This means no more needles and with values shown instantly onscreen, the ToxCO® will save more lives.”

PLEASE NOTE: The ToxCO® is not available for sale in the USA at this time.

 

REFERNCES
1. Humber, A. (2009) ‘A Feasibility study into the prehospital carbon monoxide poisoning of patients’, London Ambulance Service NHS.
2. QuickStats: Average Annual Number of Deaths and Death Rates from Unintentional, Non–Fire-Related Carbon Monoxide Poisoning,*† by Sex and Age Group — United States, 1999–2010 [Internet]. Cdc.gov. 2018 [cited 11 January 2018]. Available from: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6303a6.htm
3. CO Health Risks – Detect Carbon Monoxide [Internet]. Detect Carbon Monoxide. 2017 [cited 17 January 2018]. Available from: http://www.detectcarbonmonoxide.com/co-health-risks/