CPAP 清洁和消毒器械

医疗器械受食品和药物管理局 (FDA) 管制,该机构是负责确保供人类使用的医疗器械的安全性和有效性的美国联邦机构。此类器械包括持续气道正压通气 (CPAP) 清洁和消毒器械。

我们发现主要有两种医疗器械声称可以清洁 CPAP 器械。一种器械使用臭氧气,另一种器械使用紫外线光。到目前为止,FDA 尚未对任一类型的机器可清洁 CPAP 器械做出批准或核准。

事实上,FDA 已向亚马逊明确表示上述类型的清洁器械尚未获得批准。I 类和 II 类非豁免医疗器械必须经 FDA 批准才能在美国销售(有关更多信息,请参阅 510(k) 清关)。只有符合 FDA 要求且获得授权的商品才能在亚马逊上销售。


 亚马逊官网原文详情:

CPAP Cleaning and Disinfecting Devices


Medical devices are regulated by the Food and Drug Administration (FDA), which is the U.S. federal agency that is responsible for ensuring that medical devices intended for human use are safe and effective. This includes continuous positive airway pressure (CPAP) cleaning and disinfecting devices.

We have seen two primary types of medical devices that claim to clean CPAPs. One type uses ozone gas, the second type uses ultraviolet (UV) light. To date, the FDA has not approved or cleared either type of machine to clean CPAPs.

In fact, the FDA expressly communicated to Amazon that the above types of cleaning devices are unapproved. Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. (for more information, see 510(k) Clearances). Only products that comply with FDA requirements and are authorized may be sold on Amazon.

 文章来源:亚马逊官方网站