FDA Warns Against Using Unapproved Ozone or Ultraviolet Light Products To Clean CPAP Machines
Federal health officials are warning against the use of ozone gas or ultraviolet (UV) light to clean continuous positive airway pressure (CPAP) devices or accessories, indicating these cleaning methods have not been approved and could result in adverse health consequences.
In a safety communication issued on February 27, 2020, the FDA indicates that patients and healthcare professionals should refrain from using illegally marketed ozone gas or ultraviolet (UV) light cleaning products to disinfect or sanitize CPAP devices. The warning comes after nearly a dozen reports involving patients suffering respiratory complications after trying one of these cleaning methods.
CPAP devices provide steady air pressure through a mask or nose piece, granting continuous positive airway pressure to prevent the user’s airway from collapsing, thus preventing constant broken sleep.
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The devices are often used by those diagnosed with obstructive sleep apnea, which is a condition that causes a person’s airway to collapse during sleep, resulting in short periods of time where the individual stops breathing. Individuals suffering from sleep apnea have a greater risk of experiencing adverse health and heart problems. Typically, these individuals have a higher risk of suffering hypertension, stroke, heart disease and daytime sleepiness.
The FDA indicates it has received at least 11 reports of CPAP cleaning problems involving use of ozone or UV light products from 2017 through 2019, involving individuals who experienced coughing, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing problems after using the unapproved products.
Although ozone gas is used to kill harmful bacteria for certain products, for the process to be effective in killing harmful bacteria it must be present at high concentrations that far exceed safe levels of exposure to humans. Consequently, patients could be exposed to unsafe levels of ozone gas which may result in a variety of adverse health consequences to an individual’s respiratory system.
Exposure to UV light poses a number of potential health risks for patients, including burns, eye damage or increasing the risk of skin cancer due to overexposure. The FDA indicates that it has not become aware of any injuries directly related to patients who cleaned their CPAP devices with a UV light, however, the agency warns the UV light may not be able to penetrate all components of CPAP devices and accessories, such as the plastic tubing, masks and connectors. The inadequate cleaning of these accessories could result in unsafe conditions for reuse.
The FDA has never approved the use of ozone gas-or UV light based products to clean CPAP machines and is instructing patients and healthcare professionals to stop using these cleaning methods immediately.
The FDA has identified several manufacturers who are illegally marketing ozone gas or UV light-based products for CPAP cleaning. The agency has requested they submit data demonstrating the safety and effectiveness of their products, indicating they need clearance and approval to keep marketing those items.
The FDA urges patients to follow the CPAP machine cleaning instructions provided by the manufacturers, which indicate users should only use soap and water to thoroughly rinse, cleanse and disinfect the devices.
Patients and healthcare professionals are encouraged to report any adverse events related to the products through the FDA’s MedWatch Adverse Event Reporting System.
4 Comments
RubinJuly 29, 2022 at 7:30 pm
Wow, this is a lot to take in. I have a CPAP machine and have been using the SoClean 2 since 2020. This is careless if the company knew that their machines are releasing dangerous gasses into the air. I did call them about the smell coming from the SoClean 2 machine and that it was leaving behind a burnt brown residue in my CPAP machine after cleaning. They (SoClean) did tell me it's normal and no[Show More]Wow, this is a lot to take in. I have a CPAP machine and have been using the SoClean 2 since 2020. This is careless if the company knew that their machines are releasing dangerous gasses into the air. I did call them about the smell coming from the SoClean 2 machine and that it was leaving behind a burnt brown residue in my CPAP machine after cleaning. They (SoClean) did tell me it's normal and nothing to worry or be concerned with. I've had more nasal respiratory infections, asthma attacks and migraines than before using the SoClean 2 machine. Wow, I had no idea! This is very disheartening and unbelievable for a person in my position with multiple medical issues.
AlJuly 21, 2022 at 11:50 am
I purchased and started using the Soclean device when they 1st came out. I paid over $300.00 for this unit. Several years ago, after complaing about black residue in my Dream Station humidity water tank and a smell when using my Soclean unit. I reported the black residue to Phillips and the smell being present while using the SoClean machine. I found out that there was an isuue with foam break[Show More]I purchased and started using the Soclean device when they 1st came out. I paid over $300.00 for this unit. Several years ago, after complaing about black residue in my Dream Station humidity water tank and a smell when using my Soclean unit. I reported the black residue to Phillips and the smell being present while using the SoClean machine. I found out that there was an isuue with foam breaking down in the DreamStation CPAP from Phillips and from SoClean, the smell was safe and only the OZONE cleaning action. Years before the warning came out I started experincing extreme fatigue, sinus head aches, high blood pressure, back pain, memory loss, and feeling ill at times and also had a brain tumor removed. My wife also began experiencing several symptoms including tremors, sever coughing, extreme fatigue, hand tremors, head aches, high blood pressure, back pain, memory loss, and feeling ill at times. About a year before the warnings came out the latch assy would not latch. I emailed SoClean to ask if they would replace my SoClean Machine or even send parts for repairing the latch ass'y. They said 'NO' to both and that I should purchase a new machine. I can't afford another $300.00 so I devised a bungee cord strapped under the unit with two (2) heavy duty command hooks secured to the lid. It has been keeping the lid secured tightly and I didn't have to pay SoClean another $300.00 because their system broke down. When I stopped using the SoClean unit after the latch broke, my symptoms seemed to have improved but I gave it no real thought of the foam break down connection or the OZONE cleaning smell. I fixed the latch issue with the bungee cord fix and started using the SoClean machine again. I didn't give it much thought until only recently when I read that the SoClean device may have caused these symptoms. I just received a new (I believe new & not rebuilt ) Phillips Resmed Dream Station 2. I hope that the replacement CPAP will not have any health issues with the SoClean machine if I use it. I’m believe that both, mine and my wife's illnesses could be connected to the foam break down and OZONE smells from these devices.
DianaMarch 8, 2022 at 3:41 pm
We purchased the SoClean2 on May 10, 2021, through ApriaDirect Health. We were told that the product was safe to use and that it was the best way to clean the CPAP machine. However, after using it for a while, my husband started coughing a lot. He was also having trouble breathing. We called Apria Health a few times and they kept reassuring us that everything was ok. We continued to use it until [Show More]We purchased the SoClean2 on May 10, 2021, through ApriaDirect Health. We were told that the product was safe to use and that it was the best way to clean the CPAP machine. However, after using it for a while, my husband started coughing a lot. He was also having trouble breathing. We called Apria Health a few times and they kept reassuring us that everything was ok. We continued to use it until mid-February until the coughing and lack of breath became unbearable for my husband. Since we have stopped using the SoClean2 to clean the CPAP machine my husband's systems have reduced dramatically. I am very upset that this item was sold to us under the impression that it was safe. I am hoping that no long term health issue was caused from our 9 months of using this product. Not sure why they continue to sell these items. They are not safe to use.
MarkApril 1, 2021 at 2:51 am
Purchased and started using the Soclean device in July of 2019. I began experiencing several symptoms including tremors, sever cough, nose bleeding, extreme fatigue, tremors, head aches, high blood pressure, back pain, memory loss, and feeling very ill at times. Only recently have I discovered that the Soclean 2 device has caused these symptoms. I stopped using the device a week ago and my symptom[Show More]Purchased and started using the Soclean device in July of 2019. I began experiencing several symptoms including tremors, sever cough, nose bleeding, extreme fatigue, tremors, head aches, high blood pressure, back pain, memory loss, and feeling very ill at times. Only recently have I discovered that the Soclean 2 device has caused these symptoms. I stopped using the device a week ago and my symptoms have improved and some have disappeared. I’m convinced the last year and a half of illness is from this device. I have the medical records to proof this.