FDA OKs ClearMate Device for Carbon Monoxide Poisoning

Megan Brooks

March 15, 2019

The US Food and Drug Administration (FDA) has approved the ClearMate device (Thornhill Medical) designed to more quickly treat patients suffering from carbon monoxide (CO) poisoning.

The standard treatment for CO poisoning is breathing 100% oxygen through a mask. In severe cases, patients may use a hyperbaric chamber, which delivers oxygen under higher than normal pressure.

The ClearMate device speeds up elimination of CO from the body by delivering both 100% oxygen plus a mixture of oxygen and carbon dioxide, causing the patient to breathe faster.

"The increased breathing accelerates the rate at which the carbon monoxide leaves the patient's body, allowing a normal amount of oxygen to attach to hemoglobin and be carried where it is needed throughout the body," the FDA explains in a news release.

The ClearMate device consists of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask, and hoses. It is intended for use in the emergency department setting.

CO poisoning kills nearly 500 people in the US each year and sends up to 20,000 to emergency departments because of unintended exposure to CO, primarily from poorly-maintained heating systems, or gas stoves/gas-powered generators used for heat or power during storms.

In multiple clinical studies that tested the effectiveness of the device on 100 patients, ClearMate led to faster elimination of CO than treatment with 100% oxygen alone — but was not faster than hyperbaric oxygen therapy.

"Carbon monoxide poisoning is a serious issue, affecting thousands of people each year," said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA's Center for Devices and Radiological Health.

"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 US. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time," Eydelman explained.

Marketing authorization by the FDA for ClearMate "provides patients with access to a simple, yet lifesaving device that may minimize the delay of getting vital treatment, especially in severe cases of carbon monoxide poisoning," she said.

ClearMate was reviewed under the FDA's de novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type.

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