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, 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 U.S.A at this time.
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REFERENCES
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/