COPD Foundation Position on Non-Clinical Retail Oxygen Concentrators

Posted on February 17, 2021   |   

This position statement was reviewed by the COPD Foundation Medical and Scientific Advisory Committee.


Background

Supplemental oxygen therapy is a mainstay of therapy for COPD and other chronic lung conditions. As with all medical devices, oxygen concentrators intended for clinical use in the outpatient setting must undergo a rigorous approval process to demonstrate both safety and efficacy before sales and distribution are permitted. This assures that those who need supplemental oxygen therapy can be confident that their needs will be met by their equipment.

Over-The-Counter Oxygen Concentrators

Recently, a number of lower-cost devices being marketed as oxygen concentrators (as well as 'oxygen generators') have appeared on retail websites such as Amazon.com and eBay.com and Facebook. These devices are appealing to many, as they are readily accessible without a prescription and at a fraction of the retail cost of approved devices. They are also often marketed with stock images of people using standard oxygen cannulas, as well as stock images of people wearing clinical attire, implying these items are the equivalent to approved medical devices. Comments and (potentially seller-generated) reviews in the retail listings often indicate these units are safe and effective for patients requiring up to 7 liters per minute of flow, leading many to believe these units are appropriate for their needs. However, the technical specifications (which are often obfuscated or difficult to find), reveal that the purity of the oxygen delivered is as low as 30%, an unsafe level far below regulatory standards.

COPD Foundation Position

At this time the FDA has not approved the purchase of oxygen concentrators without a prescription. The COPD Foundation does not recommend the purchase or use oxygen concentrators that are not approved for use as Medical Devices for the treatment of COPD or other chronic lung condition. We advocate for these unregulated devices to be removed from the marketplace due to the high levels of risks they pose. The COPD Foundation encourages all individuals to discuss oxygen therapy with their personal clinical team and adhere to their prescribed regimen.

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