FDA Warns Against Anti-Choking Devices, Recommends Heimlich Maneuver

FDA warns against using anti-choking devices, recommends Heimlich maneuver as proven, effective method to save lives in choking emergencies.

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FDA Warns Against Anti-Choking Devices, Recommends Heimlich Maneuver

FDA Warns Against Anti-Choking Devices, Recommends Heimlich Maneuver

The U.S. Food and Drug Administration (FDA) issued a safety communication on Monday warning against the use of over-the-counter anti-choking devices and instead recommending the Heimlich maneuver as the preferred method for responding to choking emergencies. The FDA stated that the safety and effectiveness of these devices have not been established, and they are not FDA approved or cleared.

While the agency acknowledged it was not aware of any serious injuries or deaths associated with the use of anti-choking devices, it expressed concern that using them could waste precious time in an emergency. "Established choking rescue protocols, which rely on the Heimlich maneuver, have a high success rate and can be performed immediately without devices, saving valuable time," the FDA said in its warning.

The leading anti-choking device on the market, the LifeVac, is FDA registered as a Class II medical device but is exempt from premarket clearance. In response to the FDA's warning, LifeVac defended its product, stating that it "has saved over 100 lives worldwide, with no adverse effects from its use ever reported."

Why this matters: Choking is a leading cause of injury and death among children, with thousands of cases reported each year in the United States alone. The FDA's warning emphasizes the significance of using proven, time-tested methods like the Heimlich maneuver to quickly and effectively respond to choking emergencies.

The FDA emphasized that this safety communication is part of its ongoing commitment to advancing health equity and ensuring people get the care they need. The agency is collaborating with various stakeholders, including patient groups, healthcare providers, the medical device industry, and housing experts, to build the "Home as a Health Care Hub" initiative. The FDA said it will keep the public informed as additional information becomes available.

Key Takeaways

  • FDA warns against using over-the-counter anti-choking devices, recommends Heimlich maneuver.
  • FDA states safety and effectiveness of anti-choking devices are unestablished and not FDA-approved.
  • Leading anti-choking device LifeVac is FDA-registered but exempt from premarket clearance.
  • Choking is a leading cause of injury and death, Heimlich maneuver is a proven, effective method.
  • FDA collaborating with stakeholders to advance health equity and ensure proper emergency care.