Carbon Monoxide Poisoning Treatment Device Approved by FDA

To help treat carbon monoxide poisoning, federal regulators have approved a new medical device that is designed to quickly remove carbon monoxide from the body, reducing the risk of brain damage from the toxic gas and increasing the survival odds.

The FDA issued a press release on March 14, to announce the approval of ClearMate, which gives carbon monoxide poisoning victims oxygen and increases their breathing rate. This allows the gas to leave the body faster. The approval was granted to the manufacturer, Thornhill Research, Inc.

“Carbon monoxide poisoning is a serious issue, affecting thousands of people each year,” Dr. Malvina Eydelman, director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA Center for Devices and Radiological Health, said in the press release. “While the current standard treatment of administering 100 percent oxygen through a mask can be done anywhere, hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire U.S. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time.”

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The ClearMate is much smaller and portable, consisting of a gas mixer, oxygen reservoir, mask, hoses, valves, meters and breathing circuits. According to the press release, it has undergone multiple clinical studies which tested its safety and effectiveness on a total of 100 patients.

Carbon monoxide is a colorless and odorless gas that is produced by the incomplete burning of various fuels, including coal, wood, charcoal, oil, kerosene, propane, and natural gas. The gas is often referred to as the “silent killer,” since it is difficult to detect without the use of a properly functioning detector or alarm, and is a leading cause of poisoning deaths in the United States.

Due to the inability to detect the gas without the use of a carbon monoxide detector, individuals may be exposed to low levels of the gas over a long period of time, potentially resulting in severe injury or permanent brain damage from carbon monoxide poisoning.

The initial symptoms of carbon monoxide exposure may cause feelings of nausea, headaches, dizziness, drowsiness, and shortness of breath, whereas prolonged exposure may result in mental confusion, vomiting, loss of muscle coordination or control, loss of consciousness, and ultimately death. It is common for individuals to mistake the initial symptoms of CO exposure for the flu, often times prolonging treatment and causing increased adverse health effects.

The FDA indicates that nearly 500 people die every year in the U.S. due to carbon monoxide poisoning, which causes about 20,000 emergency room visits each year.


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