FDA NewsPerspective

FDA grants marketing authorization to carbon monoxide poisoning treatment

The FDA recently granted marketing authorization to Thornhill Research’s ClearMate device that assists in treating patients with carbon monoxide poisoning, according to an FDA press release.

ClearMate — a novel device consisting of hoses, mask, oxygen reservoir, breathing circuits, gas mixer, meters and valves — delivers 100% oxygen and a combination of oxygen and carbon dioxide to the patient, allowing faster breathing, the release stated. The device speeds up the rate carbon monoxide leaves the patient’s body and allows a normal amount of oxygen to attach to hemoglobin and be delivered to where it is needed throughout the body.

Emergency Room Sign 
The FDA recently granted marketing authorization to Thornhill Research’s ClearMate device that assists in treating patients with carbon monoxide poisoning, according to an FDA press release.

Source: Adobe

“While the current standard treatment of administering 100% 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.,” 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 said in the release.

“Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization 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 continued.

The FDA granted authorization based on data that showed ClearMate was effective at eliminating carbon monoxide in 100 patients. These patients also did not experience any device-related complications.

ClearMate was reviewed as part of the FDA’s De Novo premarket review pathway process.

Disclosure: Eydelman works for the FDA.

The FDA recently granted marketing authorization to Thornhill Research’s ClearMate device that assists in treating patients with carbon monoxide poisoning, according to an FDA press release.

ClearMate — a novel device consisting of hoses, mask, oxygen reservoir, breathing circuits, gas mixer, meters and valves — delivers 100% oxygen and a combination of oxygen and carbon dioxide to the patient, allowing faster breathing, the release stated. The device speeds up the rate carbon monoxide leaves the patient’s body and allows a normal amount of oxygen to attach to hemoglobin and be delivered to where it is needed throughout the body.

Emergency Room Sign 
The FDA recently granted marketing authorization to Thornhill Research’s ClearMate device that assists in treating patients with carbon monoxide poisoning, according to an FDA press release.

Source: Adobe

“While the current standard treatment of administering 100% 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.,” 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 said in the release.

“Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization 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 continued.

The FDA granted authorization based on data that showed ClearMate was effective at eliminating carbon monoxide in 100 patients. These patients also did not experience any device-related complications.

ClearMate was reviewed as part of the FDA’s De Novo premarket review pathway process.

Disclosure: Eydelman works for the FDA.

    Perspective
    Daniel Bachmann

    Daniel Bachmann

    Editor’s Note:

    Though Daniel Bachmann, MD, could not comment on the ClearMate specifically, he did discuss the science behind advanced carbon monoxide therapies to assist clinicians in making treatment decisions. 

    With spring here, at least from the calendar’s perspective, many of our patients are turning off their dwelling’s heating unit and the thought of carbon monoxide poisoning may not be at the top of their minds. But winter will return, and with it, the threat of this condition that in extreme cases can be deadly. Here at my ED in Ohio, at the height of the winter season, we were getting patients referred to us with carbon monoxide poisoning almost on a daily basis, so trust me, it is almost certain you will encounter a patient with carbon monoxide poisoning at least once in your professional lifetime.  

    The current standard treatment for these patients starts with administering 100% oxygen through a mask and can be done just about anywhere. The next level of treatment for more severe carbon monoxide exposures employs the use of a hyperbaric oxygen chamber. This specialized equipment is only found at centers with staff specifically trained in its use. The technology allows a patient to breathe 100% oxygen with the application increased ambient pressure. This combined environment allows arterial oxygen levels 20- to 25-fold greater than normal ambient conditions. The removal of carbon monoxide from hemoglobin in the body is significantly expedited by up to 10-fold allowing overall reduced toxic effects.   

    I can tell you that, generally speaking, hyperbaric oxygen treatment is much faster than breathing normal air and/or breathing oxygen through a mask. Additionally, some studies have shown that patients treated with hyperbaric oxygen are less vulnerable to the long-term neurological sequelae of carbon monoxide poisoning. However, there are also some studies that suggest hyperbaric oxygen treatment does not influence these delayed neurologic symptoms. But if it were my family member meeting the indications for carbon monoxide poisoning, I would use hyperbaric oxygen treatment to treat them since the risks to using it are minimal.

    The best thing a primary care physician can do is to emphasize prevention. This can be done by encouraging all of their patients, and if applicable, their patients’ parents, to purchase a carbon monoxide detector. An additional annual step would include having their dwelling’s heating and air conditioning system checked for normal operation. Doing so could save a life.

    • Daniel Bachmann, MD
    • director of hyperbaric medicine
      emergency medicine physician
      The Ohio State University Wexner Medical Center

    Disclosures: Bachmann reports no relevant financial disclosures.

    Perspective
    Henry A. Spiller

    Henry A. Spiller

    Editor's Note:

    Though Henry A. Spiller, MS, DABAT, FAACT, could not comment on the ClearMate specifically, he did discuss the science behind advanced carbon monoxide therapies to assist clinicians in making treatment decisions. 

    We have known for some time that carbon monoxide must be cleared from the body the same way it enters the body: through the lungs. Long before this FDA approval, studies showed providing oxygen at higher pressures to the patient, known as hyperbaric oxygen treatment, allows greater oxygen concentrations  and more dissolved oxygen in the blood, and in turn, allows the patient to clear carbon monoxide sooner than the other commonly used treatment of just 100% pure oxygen.

    The signs of carbon monoxide poisoning include blurred vision, confusion, dizziness, dull headache, nausea or vomiting, weakness and loss of consciousness. Adverse events include heart and brain damage, fetal death or miscarriage, or death. Thus, patients who present with this condition need to undergo some sort of treatment immediately.

    • Henry A. Spiller, MS, DABAT, FAACT
    • director of the Central Ohio Poison Control Center
      Nationwide Children’s Hospital assistant professor in the department of pediatrics
      College of Medicine
      The Ohio State University

    Disclosures: Spiller reports no relevant financial disclosures.