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The truth about FDA’s Warning on SoClean and Ozone CPAP Cleaning Devices
FDA Guidance on Ozone CPAP Cleaning Devices
If you use CPAP therapy, you may have seen supplemental devices that use ozone gas to treat CPAP masks and tubing. The FDA has previously raised concerns about ozone-based products and has issued safety information regarding certain SoClean devices.
Understanding the difference between supplemental treatment devices and routine physical cleaning is important when maintaining CPAP equipment.
FDA Information About SoClean2 and SoClean3
In November 2023, SoClean announced a voluntary recall involving SoClean2 and SoClean3 equipment. The recall included updated instructions and a hose and mask adapter intended to reduce the potential risk of ozone exposure.
The FDA recommends that users of affected SoClean2 and SoClean3 equipment follow the updated manufacturer's instructions and use the appropriate hose and mask adapter.
In August 2024, the FDA also announced that a different product, SoClean3+, had been authorized for marketing as an add-on after regular cleaning to reduce bacteria on certain CPAP masks and ventilation hoses.
SoClean3+ should therefore not be confused with the earlier SoClean2 and SoClean3 products addressed by the recall.
Why the FDA Has Raised Concerns About Ozone
Ozone is a reactive gas. The FDA has reported concerns about potential exposure to ozone generated by devices used with CPAP equipment.
According to the FDA, reports associated with ozone-based CPAP products have included symptoms such as:
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Breathing difficulty
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Headaches
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Asthma attacks
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Other respiratory symptoms
The FDA has also noted that residual ozone may remain in CPAP equipment after an ozone treatment cycle.
Ozone Treatment Does Not Replace Regular Cleaning
An important distinction is that supplemental ozone treatment is not a substitute for the routine cleaning recommended by CPAP manufacturers.
The FDA advises CPAP users to follow the cleaning instructions supplied by the manufacturer of their equipment.
For many detachable CPAP components, these instructions involve washing with mild soap and water, rinsing thoroughly, and allowing the components to dry completely.
Physical Cleaning of CPAP Accessories
Physical washing helps remove material that accumulates during normal use, including:
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Skin oils
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Dust
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Dirt
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Residue
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Deposits in humidifier chambers
CPAP masks, detachable hoses, connectors, and humidifier chambers should be maintained according to the instructions provided by their respective manufacturers.
Electrical CPAP machines should never be submerged in water. Follow the manufacturer's instructions for cleaning the exterior of the machine and other non-submersible components.
Follow Your Equipment Manufacturer's Instructions
There is no single cleaning procedure appropriate for every CPAP system or accessory.
Cleaning schedules, approved detergents, water temperatures, soaking instructions, and replacement intervals may vary by manufacturer and product.
For that reason, CPAP users should always consult the instructions supplied with their equipment before cleaning masks, hoses, humidifier chambers, filters, or other components.
The Bottom Line
The FDA's guidance makes an important distinction between routine physical cleaning and supplemental devices intended to reduce bacteria or otherwise treat CPAP accessories.
Regular cleaning should be performed according to the CPAP manufacturer's instructions. Supplemental devices should not be considered replacements for the manufacturer's recommended cleaning process.
Consumers using SoClean2 or SoClean3 should review the FDA's safety communication and the manufacturer's updated instructions. Consumers considering supplemental CPAP treatment products should also verify the product's current FDA regulatory status and intended use.
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