TUESDAY, April 23, 2024 -- The U.S. Food and Drug Administration is advising people to use the Heimlich maneuver to aid a choking victim and not rely on over-the-counter anti-choking devices.'The safety and effectiveness of over-the-counter anti-choking devices have not been established; they are not FDA approved or cleared,' the agency said in a safety communication issued Monday.The FDA admitted that it is 'not aware of any serious injuries reported with the use of these devices, and no deaths have been associated with the use of anti-choking devices.' However, the agency is concerned that fumbling with these one-use-only devices could cost precious time in an emergency.The leading device, the $70 LifeVac, comes with a mask that fits over a person's nose or mouth and attaches to a plunger-like bellows.

2024年4月23日，星期二——美国食品和药物管理局（FDA）建议人们使用海姆利希（Heimlich）方法来帮助窒息的受害者，而不要依赖非处方的防窒息设备非处方防窒息装置的安全性和有效性尚未确定；该机构在周一发布的一份安全通讯中说，它们未经FDA批准或批准。FDA承认，它“不知道使用这些设备有任何严重伤害的报告，也没有死亡与使用防窒息设备有关。”然而，该机构担心，在紧急情况下摸索这些一次性设备可能会花费宝贵的时间。领先的设备是售价70美元的LifeVac，它配有一个面罩，可以套在人的鼻子或嘴巴上，并连接到一个柱塞状的波纹管上。

Pushing the bellows down and then quickly up creates a vacuum to clear the airway.The LifeVac website contains a 'Hall of Saves' presenting thousands of cases in which the device has saved a child or adult from choking, as well as a page devoted to medical journal articles about the gadget.The company informs consumers that the LifeVac is 'FDA registered as a Class II medical device,' adding that 'it is exempt from premarket clearance.

向下推风箱，然后迅速向上推，产生真空以清除气道。LifeVac网站上有一个“拯救大厅”，展示了数千例该设备拯救儿童或成人免于窒息的案例，还有一个专门用于医学期刊文章的页面。该公司告知消费者，LifeVac是“FDA注册的II类医疗器械”，并补充说“它不需要上市前许可”。

The FDA does not require a premarket review of the LifeVac device. Currently, in the United States, all portable suction devices are required to be registered with the FDA, not approved.'Still, the FDA says people should not rely on these devices because established choking rescue protocols, which rely on the Heimlich, 'have a high rate of success and can be carried out immediately without devices, saving valuable time.'More InformationWhatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbo.

FDA不要求对LifeVac设备进行上市前审查。目前，在美国，所有便携式抽吸设备都需要在FDA注册，但未经批准。”尽管如此，美国食品和药物管理局表示，人们不应该依赖这些设备，因为依赖海姆利希（Heimlich）建立的窒息救援协议“成功率很高，可以在没有设备的情况下立即进行，节省了宝贵的时间。”更多信息无论您感兴趣的主题是什么，请订阅我们的时事通讯，在您的inbo中获得Drugs.com的最佳信息。