How Do Ozone Cleaners Affect the Safety of CPAP Machines?

 Posted on January 28,2022 in Recalled Devices

Millions of people have been affected by the recall of CPAP and BiPAP machines performed by Philips Respironics in 2021. These devices were recalled because of a foam that was used in the machines for noise-dampening purposes. The degradation of the foam, which could occur throughout the life of a device, could potentially lead to small foam particles and toxic chemicals being inhaled by users while they were receiving treatment for sleep apnea. One issue that was raised by Philips in its recall notice was the use of certain types of cleaning devices that purified CPAP parts through the use of ozone. CPAP users who also used ozone cleaners will want to understand how this may have affected their health and safety.

Manufacturer of Ozone Cleaners Sues Philips Respironics

When it issued its notice recalling multiple different types of CPAP and BiPAP devices, as well as medical ventilators, Philips stated that the use of unapproved cleaning methods, including cleaning devices that use ozone, may have exacerbated the degradation of the foam in the devices, increasing the likelihood that users could be exposed to harmful particles and chemicals. In October of 2021, SoClean Inc, a manufacturer of ozone cleaners, filed a lawsuit against Philips, claiming that the company had made false and misleading claims about the causes of foam degradation. The lawsuit stated that SoClean’s sales have fallen and its brand’s reputation has suffered as a result of the statements made by Philips. It also stated that Philips is attempting to divert blame for injuries suffered by CPAP users, when the true reasons for these issues are design flaws and a poor choice of materials. SoClean believes that the use of ozone when cleaning CPAP machines does not lead to the breakdown of foam, but degradation is actually caused by high humidity and contact with water.

Ozone CPAP Cleaners Not Approved by FDA

While it is still unclear whether the use of ozone cleaning devices is a factor in the degradation of foam in CPAP devices, it should be noted that these types of cleaners have not been approved by the FDA. Instead, the FDA recommends that users follow the manufacturer’s cleaning instructions, which usually state that CPAP devices and parts should be cleaned with soap and water.

SoClean is also facing multiple lawsuits from users who believe that they suffered harm due to exposure to ozone gas. Ozone is toxic, and the concentration of this gas that is needed to kill germs may cause harm if it is inhaled. The FDA has received reports that users of ozone CPAP cleaners have experienced symptoms such as headaches, asthma, and difficulty breathing. Exposure to ozone may also lead to irritation of the airways or respiratory infections.

Contact Our CPAP Health Issues Attorneys

If you are concerned about how your use of a CPAP device or related products may have affected your health, we can advise you of your options, and we will work with you to determine whether you can pursue financial compensation for the injuries or illnesses that you have suffered. Contact our CPAP recall lawyers today to set up a free consultation.

Sources:

https://www.fda.gov/consumers/consumer-updates/cpap-machine-cleaning-ozone-uv-light-products-are-not-fda-approved

https://www.fda.gov/medical-devices/safety-communications/potential-risks-associated-use-ozone-and-ultraviolet-uv-light-products-cleaning-cpap-machines-and

https://www.reuters.com/legal/litigation/soclean-sues-philips-disparaging-ozone-cpap-cleaners-2021-10-13/