The FDA has authorized the SoClean company to market its SoClean3 device as its most recent product for sanitizing CPAP devices beyond the routine cleaning process outlined in all CPAP instruction manuals. Along with this authorization, the FDA is notifying the public of SoClean’s 2023 recall, which involved a release of updated instructions and add-on equipment for the SoClean2 (UCP 187293000860) and SoClean3 (UDI (01)00858242007147).
A CPAP machine delivers continuous positive airway pressure to people with obstructive sleep apnea. Sleep apnea is a condition that can cause airways to close during sleep. The CPAP prevents the airways from closing to ensure that users are able to breath continuously throughout the night without the interruptions customary of sleep apnea. While the manufacturer instructions for CPAP machines direct all users to clean their devices with soap and water, some customers have opted to purchase products intended to further sanitize CPAP masks and hoses through the application of ozone gas, or activated oxygen.
The SoClean3+ device and its predecessors are used to apply ozone to the hoses and masks attached to CPAP machines, as described above. Used in high enough concentrations, the ozone can destroy harmful bacteria. When used as initially directed, however, customers ran the risk of exposure to potentially harmful levels of ozone gas. According to the EPA, ozone exposure can cause “respiratory symptoms [that] include coughing; throat irritation; pain, burning, or discomfort in the chest when taking a deep breath; chest tightness, wheezing, or shortness of breath.” The EPA also indicates that exposure to ozone may increase a person’s risk for developing asthma.
In April, 2023, SoClean responded to concerns about possible exposure to dangerous levels of ozone by issuing an updated instruction manual and a hose and mask adaptor. When placed between the ozone tubing and the ventilation hose, the adaptor prevents ozone gas from entering the CPAP machine and its water reservoir, thereby reducing exposure for users.
The FDA wishes to remind the public of the following safety guidelines for use of the SoClean3+ and older devices:
- Customers should always use the appropriate adaptors when utilizing the SoClean devices to clean their CPAP machines and accessories.
- SoClean devices should not be used while the customer is wearing or utilizing their CPAP machine.
- All customers should familiarize themselves with the SoClean user manual and follow all safety instructions
- Customers should read the user manual for their CPAP machines and follow all relevant instructions for cleaning the device. If the CPAP manufacturer cautions against using an ozone cleaner, customers should heed the instructions.
- Anyone with potential sensitivities to ozone gas, such as people with asthma, COPD, or a cardiovascular disease, should speak with their doctor before using an ozone product to sanitize their CPAP machine.
Ultimately, the FDA also wishes to remind the public that while SoClean is authorized to market their product, ozone devices are not FDA-approved for cleaning CPAP machines and other medical devices.
Anyone with questions about the FDA warning can contact the Division of Industry and Consumer Education (DICE) at 800-638-2041 or 301-796-7100.
Customers can learn more about the SoClean recall via the link listed below to the notice listed on the company’s website.
If you or a loved one has experienced an adverse health outcome linked to using a product marketed for cleaning medical devices with ozone, the team at TruLaw would like to hear more about your experience. You deserve recourse for the physical, emotional, and financial consequences of your injury. TruLaw will help you hold the negligent parties responsible. Get started today by contacting us or taking our free Instant Case Evaluation ℠.