The device is intended to be used as an adjunct to reduce bacteria on certain CPAP masks and hoses after cleaning.
RT’s Three Key Takeaways:
- FDA De Novo Clearance: The FDA granted marketing authorization to SoClean for its SoClean 3+ bacterial reduction device for use with two CPAP accessories (ResMed’s ClimateLine Air tubing and SlimLine tubing) and one mask (Resmed’s Mirage FX) in conjunction with the ResMed AirSense 10 CPAP device.
- 99.9% Bacterial Reduction: SoClean notes the SoClean 3+ device has been shown to achieve 99.9% bacterial reduction on CPAP hoses and masks.
- Upgrade Program: SoClean plans to introduce an upgrade program within the next 60 days for current SoClean users and users of other CPAP cleaning devices.
SoClean, a maker of bacterial reduction systems for CPAP hoses and masks, announced it has been granted De Novo clearance by the US Food and Drug Administration (FDA) for SoClean 3+.
SoClean 3+ is intended to be used as an adjunct to reduce bacterial populations on certain compatible home-use CPAP masks and ventilation hoses after cleaning. The FDA notes the device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers.
The device is established for use with the ResMed Mirage FX nasal mask, ResMed ClimateLine Air (tubing), and ResMed SlimLine (tubing) for the ResMed AirSense 10. Moving forward, SoClean is working to establish additional hoses and masks for use with the SoClean 3+ bacterial reduction device.
According to SoClean, the device has been demonstrated to achieve 99.9% bacterial reduction in CPAP hoses and masks.
[RELATED: SoClean Issues Voluntary Recall of Equipment Used to Clean CPAPs]
“Sleep apnea is a growing issue worldwide, which impacts users’ ability to get a proper night’s rest. Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users,” says CEO Robert Wilkins in a release.
SoClean will communicate to customers how to upgrade their current SoClean devices to a SoClean 3+ within the next 60 days. Additionally, SoClean will be offering an upgrade program to users of any other CPAP hose and mask cleaning devices.
SoClean is an independent company not affiliated with ResMed Inc.
Photo caption: SoClean 3+
Photo credit: SoClean
