According to the lawsuits, SoClean's product was not safe because it omits harmful levels of ozone gas which exceeded the maximum safe limits set by the FDA.
The use of an ozone cleaner such as the SoClean can make this worse. While the number of people actually experiencing problems has been quite small, there is enough concern to trigger this recall. Respironics is recalling all their PAP machines manufactured before April 2021.
Ozone gas (used in SoClean and other devices) does kill bacteria. However, the ozone levels required to kill bacteria are unsafe for humans. Further, ozone would have a hard time killing bacteria that are covered in dirt, so the CPAP devices and accessories being sanitized should be cleaned first, anyway.
SoClean is an integrated CPAP cleaner and falls into that category of not recommended. ResMed came out against the use of Ozone on their CPAP machine a couple years back. They went as far as telling customers that use of ozone CPAP cleaners on their device may void the warranty.
SoClean 2 Go Travel CPAP/BiPAP Cleaner - DISCONTINUED.
FDA Approved: The SoClean 2 CPAP Sanitiser - Intus Healthcare.
If you have owned or used a SoClean cleaner device to sanitize your CPAP machine, you may have the standing to join a class action lawsuit for your exposure to toxic levels of ozone.
Warm water and mild soap is the best way to clean your CPAP machine, but if you choose to use a CPAP cleaner it is important to understand their limitations and the potential health risks.
The best CPAP cleaner for you
The SoClean 2 CPAP Sanitizer (ozone) 3B Medical Lumin CPAP Cleaner (UV) 3B Medical Lumin Bullet UV Hose Cleaner (UV)
Do not use moisturizing soaps, bleach, scented oils, chlorine, or alcohol-based solutions to clean your supplies. These solutions may cause irritation to your skin and lungs and may reduce the life of your products. Dawn Dish soap or Comparable works best for daily cleaning.
When used as instructed, CPAP sanitizers using ozone gas can still be safely used to clean CPAP equipment, such as masks, tubing, headgear, nasal pillows, and humidifier water chambers. It is not recommended to connect your CPAP cleaning device directly to your CPAP machine.
Sometimes you may experience a strong odor after running the SoClean for the first time. This is a byproduct of the oxidation with activated oxygen of the old materials that may have been used to clean your CPAP equipment in the past, such as vinegar or scented soaps.
FDA Tests CPAP Cleaners
The testing demonstrated that devices using ozone disinfection generated ambient levels of ozone above limits considered safe for human exposure.
As of February 1, 2020, ResMed has indicated that ozone damage will void the CPAP manufacturer's warranty. Therefore, they recommend that SoClean not be used with ResMed CPAP machines.
How long will the SoClean machine last? We warranty the SoClean for two years. However, in our testing we simulated running the machine for over 5 years and experienced no issues. 7.
This adapter should be used for customers using a CPAP or BiPAP without a heated humidifier. The fitting part will connect directly to your machine, allowing your SoClean to give your equipment a quick and hygienic cleansing.
Best CPAP Cleaner Overall: SoClean 3
The SoClean 3 is by far our top recommendation when it comes to CPAP cleaners. It's a popular model that's received a number of positive reviews for its effectiveness and simple-to-use design. It uses activated oxygen technology to destroy germs and bacteria.
Does SoClean Enjoy Insurance Cover? SoClean doesn't currently enjoy insurance cover. You may, however, use the funds kept in the FSA or HSA to buy a Soclean cpap cleaner. Both FSA and HSA can provide great cost-reducing options.
The Lumin CPAP Cleaner offers extra cleaning protection using UV light to thoroughly sanitize your equipment. The Lumin kills 99.9% of harmful bacteria, viruses, mold, and fungus. It is completely ozone-free and the process takes only 5 minutes.
CPAP equipment manufacturers recommend regular cleanings. They advise washing out the mask, tubing and CPAP humidifier chamber at least once a week. Rinsing the mask and hose daily is also a good practice that helps keep them clean in the interim. Experts also recommend washing the parts out daily if you are sick.
You can do this by running the CPAP without any water in the water reservoir for a few minutes until it is dry. Or take the CPAP Tube off and hang it over a doorway until it is completely dry. Turn your Humidity Setting down on your CPAP.
Are there any products I should avoid? You should always follow the cleaning instructions in your mask user guide and use mild soap. We recommend using ordinary washing up liquid or baby shampoo to wash your mask and headgear. You can also use CPAP Mask Cleansing Wipes.
We are unable to credit a refund to your account without an RMA number, nor in many cases will we be able to return the product back to you. Once the product has been received and inspected, a refund will be issued. Refunds are processed within approximately 1 to 2 weeks of our receipt of your merchandise.
To keep your SoClean running optimally, you'll need to change its filter and check valve about every six months. The SoClean Cartridge Filter Kit, available for sale on soclean.com, includes both of these components.
The SoClean 2 does not use water or chemicals. SoClean and SoClean 2 are two different models of a CPAP cleaning device.